Scolaris Content Display Scolaris Content Display

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Funnel plot of comparison: 5 Music versus standard care, outcome: 5.1 Anxiety.
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Figure 3

Funnel plot of comparison: 5 Music versus standard care, outcome: 5.1 Anxiety.

Comparison 1 Audiovisual distraction versus music, Outcome 1 Anxiety.
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Analysis 1.1

Comparison 1 Audiovisual distraction versus music, Outcome 1 Anxiety.

Comparison 1 Audiovisual distraction versus music, Outcome 2 Pain.
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Analysis 1.2

Comparison 1 Audiovisual distraction versus music, Outcome 2 Pain.

Comparison 2 Audiovisual distraction versus standard care, Outcome 1 Anxiety.
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Analysis 2.1

Comparison 2 Audiovisual distraction versus standard care, Outcome 1 Anxiety.

Comparison 2 Audiovisual distraction versus standard care, Outcome 2 Pain.
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Analysis 2.2

Comparison 2 Audiovisual distraction versus standard care, Outcome 2 Pain.

Comparison 3 Music versus blank tape / headphones only, Outcome 1 Anxiety.
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Analysis 3.1

Comparison 3 Music versus blank tape / headphones only, Outcome 1 Anxiety.

Comparison 3 Music versus blank tape / headphones only, Outcome 2 Heart rate.
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Analysis 3.2

Comparison 3 Music versus blank tape / headphones only, Outcome 2 Heart rate.

Comparison 3 Music versus blank tape / headphones only, Outcome 3 Blood pressure.
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Analysis 3.3

Comparison 3 Music versus blank tape / headphones only, Outcome 3 Blood pressure.

Comparison 3 Music versus blank tape / headphones only, Outcome 4 Respiration rate: with choice of outcomes.
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Analysis 3.4

Comparison 3 Music versus blank tape / headphones only, Outcome 4 Respiration rate: with choice of outcomes.

Comparison 3 Music versus blank tape / headphones only, Outcome 5 Skin conductance.
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Analysis 3.5

Comparison 3 Music versus blank tape / headphones only, Outcome 5 Skin conductance.

Comparison 3 Music versus blank tape / headphones only, Outcome 6 Stress hormones.
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Analysis 3.6

Comparison 3 Music versus blank tape / headphones only, Outcome 6 Stress hormones.

Comparison 4 Music versus scheduled rest, Outcome 1 Anxiety.
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Analysis 4.1

Comparison 4 Music versus scheduled rest, Outcome 1 Anxiety.

Comparison 4 Music versus scheduled rest, Outcome 2 Heart rate.
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Analysis 4.2

Comparison 4 Music versus scheduled rest, Outcome 2 Heart rate.

Comparison 4 Music versus scheduled rest, Outcome 3 Blood pressure.
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Analysis 4.3

Comparison 4 Music versus scheduled rest, Outcome 3 Blood pressure.

Comparison 4 Music versus scheduled rest, Outcome 4 Respiration rate.
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Analysis 4.4

Comparison 4 Music versus scheduled rest, Outcome 4 Respiration rate.

Comparison 5 Music versus standard care, Outcome 1 Anxiety.
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Analysis 5.1

Comparison 5 Music versus standard care, Outcome 1 Anxiety.

Comparison 5 Music versus standard care, Outcome 2 Heart rate.
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Analysis 5.2

Comparison 5 Music versus standard care, Outcome 2 Heart rate.

Comparison 5 Music versus standard care, Outcome 3 Blood pressure.
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Analysis 5.3

Comparison 5 Music versus standard care, Outcome 3 Blood pressure.

Comparison 5 Music versus standard care, Outcome 4 Respiration rate.
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Analysis 5.4

Comparison 5 Music versus standard care, Outcome 4 Respiration rate.

Comparison 5 Music versus standard care, Outcome 5 Sedation requirements (anxiolytics).
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Analysis 5.5

Comparison 5 Music versus standard care, Outcome 5 Sedation requirements (anxiolytics).

Comparison 5 Music versus standard care, Outcome 6 Peripheral skin temperature.
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Analysis 5.6

Comparison 5 Music versus standard care, Outcome 6 Peripheral skin temperature.

Comparison 5 Music versus standard care, Outcome 7 Oxygen saturation.
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Analysis 5.7

Comparison 5 Music versus standard care, Outcome 7 Oxygen saturation.

Comparison 5 Music versus standard care, Outcome 8 Mood state.
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Analysis 5.8

Comparison 5 Music versus standard care, Outcome 8 Mood state.

Comparison 5 Music versus standard care, Outcome 9 Satisfaction.
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Analysis 5.9

Comparison 5 Music versus standard care, Outcome 9 Satisfaction.

Comparison 5 Music versus standard care, Outcome 10 Length of stay / Examination time.
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Analysis 5.10

Comparison 5 Music versus standard care, Outcome 10 Length of stay / Examination time.

Comparison 6 Music versus white noise, Outcome 1 Heart rate.
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Analysis 6.1

Comparison 6 Music versus white noise, Outcome 1 Heart rate.

Comparison 6 Music versus white noise, Outcome 2 Blood pressure.
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Analysis 6.2

Comparison 6 Music versus white noise, Outcome 2 Blood pressure.

Table 1. Aromas: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Graham 2003

RCT; 3 parallel groups.

DESCRIPTION: 313 patients undergoing radiotherapy, in Australia.
NUMBERS: Unclear how many patients per group.
AGE, mean (range): 65 (33‐90) years old.
GENDER (male/female): 163/150.
ETHNICITY: not described.
INCLUSION CRITERIA: If a course of eight or more fractions of radiotherapy was prescribed.
EXCLUSION CRITERIA: not described.

FRAGRANT PLACEBO: Patients were administered the carrier oil with low‐grade essential oils. The carrier oil was sweet almond cold‐pressed pure vegetable oil. The low‐grade fractionated oils (lavender, bergamot, and cedarwood) were of unknown purity (supplied by Naturistics, Hornsby, Australia). These fractionated oils were diluted with the carrier oil in a ratio of 1:2.
NON‐FRAGRANT PLACEBO: Patients were administered the carrier oil only: sweet almond cold‐pressed pure vegetable oil.
PURE ESSENTIAL OIL: 100% pure essential oils of lavender, bergamot, and cedarwood were administered in a ratio of 2:1:1 (supplied by "In Essence").

All patients were administered their study treatment via a necklace with a plastic‐backed paper bib, donned before radiotherapy treatment each day and removed after exiting the treatment bunker. Three drops of oil were applied to the bib. Typical duration lasted 15‐20 minutes. Patients were seated in waiting areas segregated according to study arm allocation to avoid cross‐exposure.

ANXIETY, DEPRESSION, and FATIGUE: Measured via the Hospital Anxiety and Depression Scale (HADS), and the Somatic and Psychological Health Report (SPHERE), which is composed of the General Health Questionnaire (GHQ) and Symptoms of Fatigue and Anergia (SOFA) scales.

In a multivariate analysis:
There were significantly fewer patients with anxiety >7 in the non‐fragrant placebo arm than both the essential oil (Odds ratio = 2.6, 95% CI = 1.1 to 6.1), and fragrant placebo (Odds ratio = 2.8, 95% CI = 1.1 to 6.7) groups.

There were no significant differences between groups in depression scores, the General Health Questionnaire, and fatigue scale.

Holmes 2002

CCT; Cross‐over trial, 2 conditions.

DESCRIPTION: 15 psychiatric inpatients in the communal area of a long‐stay hospital psychogeriatric ward for patients with behavioural problems, in England.
NUMBERS: 15 patients; cross‐over trial.
AGE, mean (SD): 79.0 (6.3) years old.
GENDER (male/female): 6/9.
ETHNICITY: not described.
INCLUSION CRITERIA: International classification of disease (ICD)‐10 diagnostic criteria for severe dementia; evidence of agitated behaviour‐ defined as scoring > 3 on the Pittsburgh Agitation Scale at some point each day over the period of a week.
EXCLUSION CRITERIA: none described.

LAVENDER: The communal area of the unit was diffused with a standard concentration of lavender oil (2%), using three aroma‐streams for a period of two hours between the period of 4pm and 6pm.
PLACEBO: The communal area of the unit was diffused with water, using three aroma‐streams for a period of two hours between the period of 4pm and 6pm.

A total of five treatments and five placebo trials were carried out for each patient over a period of two weeks.

AGITATION: Measured on the 16‐point Pittsburgh Agitation Scale by a blinded observer for the final hour of each two hour study period. Outcomes are presented as median scores for each patient in each condition.

9 patients showed an improvement with lavender.
5 patients showed no change with lavender.
1 patient showed a worsening of condition with lavender.
Wilcoxon Signed‐Ranks test, P = 0.016

Of the 4 patients with Alzheimer's disease, 3 improved and 1 showed no change; of the 7 patients with vascular dementia, 5 improved and 2 showed no change; of the 3 patients with Dementia with Lewy Bodies, 2 showed no change and 1 worsened; the 1 patient with Fronto‐temporal lobe dementia improved.

SD: standard deviation

Figures and Tables -
Table 1. Aromas: Characteristics of included studies
Table 2. Aromas: Characteristics of excluded studies

Study ID

Reason for exclusion

Anderson 2004

Intervention

Burns 2000a

Study design

Burns 2000b

Study design

Burns 2002

Study design

Bykov 2003a

Setting and population

Girard 2004

Editorial

Hudson 1995

Study design

Hudson 1996

Outcomes

Itai 2000

Study design

Kane 2004

Data unsuitable for cross‐over study

Kirkpatrick 1998

Commentary

Lehrner 2000

Setting

Louis 2002

Setting

Redd 1994

Aromas administered via nasal cannula, judged to be too invasive to constitute an 'environmental' intervention.

Tate 1997

Intervention; outcome not validated

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Table 2. Aromas: Characteristics of excluded studies
Table 3. Art: Characteristics of excluded studies

Study ID

Reason for exclusion

Bower 1995

Qualitative report

Breslow 1993

Descriptive article

De Jong 1972

Participants

Finkelstein 1971

Intervention interactive

Finlay 1993

Qualitative report

Green 1994

News article

Guillemin 2000

Qualitative

Homicki 2004

Descriptive article

Litch 2006

Narrative article

Mellor 2001

Commentary

Palmer 1999

No group comparisons presented, unable to obtain further details from authors

Staricoff 2001

Study design

Staricoff 2003a

Study design (part of same study as Staricoff 2001)

Ulrich 1993b

Conference abstract, unable to obtain further details from author

Wikström 1992

Setting

Wikström 1993

Setting

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Table 3. Art: Characteristics of excluded studies
Table 4. Audiovisual: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Notes

Barnason 1995/1996

RCT; 3 parallel groups.

DESCRIPTION: 96 in‐patients in the cardiovascular ICU and progressive care units having undergone elective coronary artery bypass grafting, in USA.
NUMBERS: Music group = 33, Music + video group = 29, Scheduled rest group = 34.
AGE, mean (SD): 67 (9.9) years old.
GENDER (male/female): 65/31.
ETHNICITY: White = 96 (100%)
INCLUSION CRITERIA: Orientated to person, time and place; speak and read English; 19 years or older; extubated within 12 hours of surgery; removal of intra‐aortic balloon pump within 12 hours of surgery.
EXCLUSION CRITERIA: Currently using one of the intervention techniques; major hearing deficit.

MUSIC GROUP: Choice of 5 tapes: 'Country Western Instrumental' or 'Fresh Aire' by Mannheim Steamroller, 'Winter into Spring' by George Winston, or 'Prelude' or 'Comfort Zone' by Steven Halpern. Played via headphones for 30 minutes.
MUSIC + VIDEO GROUP:
Barnason 1995 states:
Choice of 2 Steven Halpern tapes: 'Summer Wind' or 'Crystal Suite'. Each is 30 minutes of soft instrumental with visual imaging.
Zimmerman 1996 states:
Choice of three 30 minute videocassettes by Pioneer Artist ('Water's Path', 'Western Light', or 'Winter').
SCHEDULED REST: 30 minutes of rest in bed or chair, visitors and staff requested not to disturb.

2 x 30 min intervention periods during afternoons of post‐operative days 2 and 3. Lights dimmed.

Barnason 1995 reports:
STATE ANXIETY: measured using STAI at three time‐points: pre‐operatively, before intervention on 2nd post‐operative day, and after intervention on 3rd post‐operative day.
ANXIETY: taken using NRS before and after each intervention session.
PHYSIOLOGICAL: HR (bpm) and BP (mm Hg) taken using the Kendall BP Monitor (Model 8200)‐ not enough data presented for extraction.
MOOD: Measured using a NRS‐ not a validated outcome.

Zimmerman 1996 reports:
PAIN: Pain was measured with a 10‐point VRS before and after each session, and with the McGill Pain Questionnaire (scores are given for the subscales and the present pain index rating scale) administered once prior to the first session, and once after the second session.
SLEEP: Measured with the Richards‐Campbell Sleep Questionnaire (RSQ), administered between 7am and 9am on the third post‐operative day.

Data extracted for state anxiety (STAI measure). Pain data are extracted for the end values on the VRS.

Patients in the music group showed a significant improvement in mood after the 2nd intervention when controlling for pre‐intervention mood rating. No differences between groups were found for anxiety on either data collection tool. Physiological measures did not differ between groups, however there were significant differences over time (regardless of group), indicating a generalised relaxation response.
Authors conclude that although no intervention was overwhelmingly superior, all groups demonstrated a relaxation response.

Diette 2003

RCT; 2 parallel groups.

DESCRIPTION: 80 in‐patients and out‐patients undergoing FB in Mariland, USA.
NUMBERS: Bedscapes group = 41, Control = 39 patients.
AGE, mean (range): Bedscapes = 52.3 (21‐88); Control = 55.3 (30‐90).
GENDER (Male/Female): Bedscapes = 16/25; Control = 22/17.
ETHNICITY (White/African‐American): Bedscapes = 25/16; Control = 28/11.
INCLUSION CRITERIA: 18 years or older, undergoing FB.
EXCLUSION CRITERIA: Non‐English speaker, contact isolation, presence of encephalopathy or significant alteration in mental status, sensory deficits that preclude use of visual/auditory aid.

BEDSCAPES GROUP: Countryside river scene with associated sounds of nature played through headphones. Intervention available before, during, and after FB procedure. The scene was mounted by the bedside in the recovery area and on the ceiling in the procedure room.
CONTROL GROUP: standard care.

ANXIETY: State anxiety via STAI;
PAIN: Pain control during procedure measured by VRS. Values presented as % with good/excellent pain control. Due to unclear missing data (> 10%), it is unclear how many people this represents.
ABILITY TO BREATHE: (poor to excellent) rating scale. Validity unclear.
SATISFACTION WITH CARE: Ratings of: willingness to return, privacy, safety, overall rating of facility. Validity unclear.

Outcomes obtained via a follow‐up survey administered on the second day following the procedure. Out‐patients completed form and returned it by mail. In‐patients forms were collected from their hospital room.

SDs for anxiety have been estimated from P value of a t‐test.

Adverse events: 1 patient in the treatment group urinated on the bronchoscopy table. The patient felt that this had occurred because of hearing sounds of running water.

Lee 2004a

RCT; 3 parallel groups.

DESCRIPTION: 157 day‐patients undergoing colonoscopy in an Endoscopy Suite in Hong Kong, China.
NUMBERS: Visual distraction = 52 patients, Audiovisual distraction = 52 patients, Control group = 53 patients.
AGE, mean (SD): Visual distraction = 45.6 (10.2), Audiovisual distraction = 48.8 (11.3), Control group = 46.3 (11.4).
GENDER (male/female): Visual distraction = 25/27, Audiovisual = 27/25, Control group = 23/30.
ETHNICITY: not described.
INCLUSION CRITERIA: Undergoing elective day‐case colonoscopy.
EXCLUSION CRITERIA: History of allergy to propofol and/or alfentanil. Receive a colectomy.

VISUAL DISTRACTION: Eyetreck system (olympus) with preset home made movie (mainly scenic views), patient wears earphones but with no sound.
AUDIOVISUAL DISTRACTION: Same as visual distraction with the addition of classical music played through earphones.
CONTROL: Standard care.
All groups received PCS using a mixture of propofol and alfentanil.

PAIN: scored using 10 cm VAS;
SATISFACTION: measured using 10 cm VAS;
Willingness to repeat procedure (using 10 cm VAS);
ANALGESICS: Dose of PCS consumed;
PHYSIOLOGICAL:
Hypotensive episodes;
Oxygen desaturation;
RECOVERY TIME: nurse assessed

Lembo 1998

RCT; 3 parallel groups.

DESCRIPTION: 37 patients undergoing flexible sigmoidoscopy in Calfornia, USA.
NUMBERS: Audiovisual group = 13, audio alone group = 12, control group = 12.
AGE, mean (SD): Audiovisual group = 58 (7), Audio alone group = 60 (8), Control group = 59 (7) years old.
GENDER: Male = 37 (100%).
ETHNICITY: not described.
INCLUSION CRITERIA: Undergoing routine screening flexible sigmoidoscopy.
EXCLUSION CRITERIA: none described.

AUDIOVISUAL: Virtual‐i glasses, personal display system showing an ocean shoreline with corresponding sounds (via headphones)
AUDIO ALONE: Sounds of the ocean shoreline only played via headphones.
CONTROL: No intervention, standard care.

DISCOMFORT: Measured via VAS which asked patients to rate their level of abdominal discomfort from faint to severly intense.
STRESS SYMPTOMS: Measured 6 subscales (arousal, stress, anxiety, anger, fatigue, and attention) using 12 VAS.

Data for discomfort entered as pain scores.

Data extracted for review on anxiety and anger. Arousal and attention not considered health‐related outcomes.

There was no difference between groups on the stress and fatigue subscales, data not reported for extraction.

Miller 1992

RCT; 2 parallel groups.

DESCRIPTION: 17 in‐patients undergoing burns care treatment and dressings change in a Burn Special Care Unit, Cincinnati, USA.
NUMBERS: Audiovisual group = 9, Control group = 8.
AGE, mean: Audiovisual group = 40.9, Control group = 27.8
GENDER (male/female): Audiovisual group = 9/0, Control group = 7/1.
ETHNICITY (white/black): Audiovisual group = 8/1, Control group = 7/1.
INCLUSION CRITERIA: 10‐40% body surface burn; expected length of stay >/= 1 week; Adult patients, 18 years or older.
EXCLUSION CRITERIA: Substance abuse disorder; unable to see/or hear; psychotic; under 18 years old; cannot understand English; mentally retarded; disorientated; multiple trauma injuries.

AUDIOVISUAL GROUP: "Muralvision" (Muralvision Studios, Inc., Eugene, Ore.)‐ on a bedside television, video programmes composed of scenic beauty (ocean, desert, forest, flowers, waterfalls, and wildlife) with accompanying music.
CONTROL GROUP: Standard care.

Participants were exposed to their treatment group on 10 occasions during dressing change.

PAIN: Measured via the McGill Pain Questionnaire, with the Pain Rating Index and Present Pain Intensity scales.
ANXIETY: Measured via the STAI.

Outcomes were measured within 2 minutes at the end of each dressing change. Outcomes are reported as the overall means and standard errors for the 10 dressing changes.

For data extraction in the review, change scores from baseline were calculated and associated estimated standard deviations, using the F statistics provided.

SD: standard deviation; STAI: State Trait Anxiety Inventory; VAS: visual analogue scale

Figures and Tables -
Table 4. Audiovisual: Characteristics of included studies
Table 5. Audiovisual: Characteristics of excluded studies

Study ID

Reason for exclusion

Allen 1989

Intervention

Egger 1981

Study design

Friedman 1992

Study design

Hoffman 2000

Intervention‐ interactive virtual reality

Hoffman 2001

Intervention‐ interactive virtual reality

Holden 1992

Intervention‐ patient education video

Martin 1999

Inadequate information provided (Ulrich study)

Oyama 2000

Intervention interactive

Pruyn 1998

Unclear validity of outcomes

Schneider 2003

Intervention interactive

Schneider 2004

Intervention interactive

Schofield 2000

Intervention‐ snoezelen

Singer 2000

Population, < 90% over 18 years old.

Tse 2003

Setting

Ulrich 2003

Setting

Wint 2002

Participants not adults

Figures and Tables -
Table 5. Audiovisual: Characteristics of excluded studies
Table 6. Decoration: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Notes

Edge 2003

RCT; 4 parallel groups.

DESCRIPTION: 39 in‐patients (10 post‐operative for cardiac surgery, 29 undergoing cardiac observations) in a cardiac care unit in Florida, USA.
NUMBERS: Beige = 13, Purple = 10, Green = 9, Orange = 7.
AGE: 26 to 89 years old.
GENDER (male/female): 20/19.
ETHNICITY: not described.
INCLUSION CRITERIA: Admitted to unit between February and March 2003.
EXCLUSION CRITERIA: Colour blind; non‐English speaking; not able to understand or confused.

BEIGE: Walls remained original colour of beige (similar to Sherwin Williams colour SW6658) in four rooms.
PURPLE: Wall at foot of bed painted purple (SW6556) in two rooms.
GREEN: Wall at foot of bed painted green (SW6451) in two rooms.
ORANGE: Wall at foot of bed painted orange (SW6346) in two rooms.

Otherwise rooms were of same decor and intervention colours were co‐ordinated with colours already present in the rooms (e.g. on bed curtains). Artwork was removed from the rooms. Rooms were double occupancy with western outlook. Curtains were combination of orange, yellow, green, blue, and purple. Laminate countertops were green, and floors were orange and green. Furniture was neutral shades of white, grey, or beech wood.

ANXIETY: Measured via STAI on day of discharge (after 2 to 5 days in hospital). Presented as mean (SD). No significant differences reported.
LENGTH OF STAY: Extracted from patient notes by researcher (days). No SDs presented. No significant differences reported.
PAIN MEDICATION REQUESTS: Extracted from patient notes by researcher. Presented as number of patients making requests and number of requests made (no SDs presented), subgrouped by first day, middle days, and final day. No significant differences reported.

Partients in this study were not approached for informed consent until Day 3 of the study.

STAI: State Trait Anxiety Inventory

Figures and Tables -
Table 6. Decoration: Characteristics of included studies
Table 7. Decoration: Characteristics of excluded studies

Study ID

Reason for exclusion

Becker 1980

Outcomes not validated

Cooper 1989

Qualitative report

Dickinson 1995

Setting

Hewawasam 1996

Study design

Hussian 1987

Study design

Jacobs 1974

Participants

Knobel 1985

Descriptive article

Namazi 1989

Study design

Rabin 1981

Descriptive article

Rice 1980

Outcomes

Steer 1975

Counfounding

Steffes 1985

Staffing confound

Figures and Tables -
Table 7. Decoration: Characteristics of excluded studies
Table 8. Music [RCT]: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Notes

Allen 2001

RCT; 2 parallel groups.

DESCRIPTION: 40 day‐patients undergoing ophthalmic surgery in New York, USA.
NUMBERS: 20 patients in each group.
AGE, mean (range): Music group = 74 (51‐87), Control group = 77 (64‐88) years old.
GENDER (male/female): Music group = 5/15, Control group = 5/15.
ETHNICITY: not described.
INCLUSION CRITERIA: Ambulatory surgical patients scheduled on the rosters of two ophthalmic surgeons.
EXCLUSION CRITERIA: none described.

MUSIC GROUP: Patient choice of 22 types of music (e.g. soft hits, classical guitar, chamber music, folk music, popular singers from 1940's and 1950's), played via headphones throughout pre‐operative, surgical, and post‐operative periods.
CONTROL GROUP: Standard care.

PHYSIOLOGICAL: HR and BP measured via Propaq Monitor (Protocol Systems, Inc., Beaverton, OR) every 5 minutes during pre‐operative, surgical, and post‐operative period. Averages for the last three recorded measures within each time period were used for analysis in the paper. For purposes of review, data is extracted for the mean post‐operative scores only.
COGNITIVE APPRAISAL: Two Likert scales used to measure questions on coping and stress, validity unclear. Not extracted for review.

Andrada 2004

RCT; 2 parallel groups.

DESCRIPTION: 118 out‐patients undergoing colonoscopy in a Digestive Endoscopy Unit in Spain.
NUMBERS: Music group = 63 patients, Control group = 55 patients.
AGE, mean (SD): Music group = 46 (14.22), Control = 49 (13.88).
GENDER (Male/Female): Music group = 31/32, Control group = 28/27.
ETHNICITY: not specified.
INCLUSION CRITERIA: 18‐75 years old, scheduled for ambulatory examination.
EXCLUSION CRITERIA: anacusis or significant bilateral hearing loss, senile dementia, cognitive disorders, acute or chronic confusional syndromes, treatment with anxiolytic medication in 72 hours prior to examination.

MUSIC GROUP: Series of classical tracks (e.g. Bach, Grieg, Mozart, Delibe, Faure, and Mendelssohn) played via headphones during procedure.
CONTROL GROUP: Wore headphones but did not receive music throughout the procedure.

ANXIETY: State anxiety measure pre and post procedure using the STAI; Reported as post ‐ pre difference with 95% CI.
ABNORMAL EVENTS: BP, capillary oxygen saturation, and HR were monitored using a Datex‐Ohmeda 3800 pulse oximeter and Nissei KTJ‐20 sphygmomanometer. Abnormal events arising from these parameters e.g. hypoxaemia, hypotension, hypertension, bradycardia, and tachycardia were recorded.

There were no significant differences between groups regarding abnormal events. This data has not been extracted for the review.

Argstatter 2006

RCT; 3 parallel groups.

DESCRIPTION: 83 in‐patients undergoing cardiac catheterization in Germany.
NUMBERS: Music group = 28, Control group = 27, Coaching group excluded from review. There are some discrepancies as to reported numbers in the paper, which also states there were 28 people in the control group.
AGE, mean (SD) [range]: Music group = 65.8 (8.4) [49‐83], Control group = 67.5 (14.0) [28‐83].
GENDER (male/female): Music group = 16/12, Control group = 15/12.
ETHNICITY: not described.
INCLUSION CRITERIA: Patients were undergoing cardiac catheterization for the first or second time.
EXCLUSION CRITERIA: none described.

MUSIC GROUP: Music was played via headphones, which were worn half on so patients could still hear the medical personnel, during the cardiac catheterization. A music therapist was present only to control the volume. Music played was "Entspannung" [relaxation] by Markus Rummel, composed specially for relaxation.
CONTROL GROUP: Standard care. This group did not have the addition of a music therapist present during the cardiac catheterization.
COACHING GROUP: Excluded from review.

ANXIETY: Measured via the STAI before and after cardiac catheterization. Unclear whether post measurements were taken on the following day after cardiac catheterization.
PHYSIOLOGICAL: BP and Pulse are reported as pre‐ and post‐measurements. Unclear how measurements were obtained.
SUBJECTIVE MUSIC QUESTIONNAIRE: excluded from review.

Ayoub 2005

RCT; 3 parallel groups.

DESCRIPTION: 90 patients undergoing urological surgery with spinal anaesthesia and PCS in Connecticut (USA) and Beirut (Lebonon).
NUMBERS: Music group = 31, White noise = 31, Operating room noise = 28.
AGE, mean (SD): Music group = 55 (12), White noise = 54 (12), OR noise = 57 (10) years old.
GENDER (male/female): Music group = 28/3, White noise = 29/2, OR noise = 24/4.
ETHNICITY: Unclear, although 36 recruited in USA, and 54 recruited in Lebonon.
INCLUSION CRITERIA: 18‐60 years old; ASA status I‐III (although Table1 states music group had a classification of V).
EXCLUSION CRITERIA: On psychiatric medications; a history of affective disorders.

MUSIC GROUP: Patients brought own music from home.
WHITE NOISE: Delivered by SoundSpa Acoustic Relaxation Machine.
OR NOISE: Delivered by mini‐amplifier speaker via occlusive headphones. This Radio Shack (R) has mini‐microphone for voice acquisition.

All groups wore occlusive headphones.

PROPOFOL REQUIREMENTS: Recorded as mg/kg/min and % of patients not using any propofol. Unclear if data presented are the SDs, and if the data presented as mg/kg/min is based on the total N or % of patients who used propofol.

Observers Assessment of Alertness/Sedation Scale (OAA/S): Data not presented.

PACU LENGTH OF STAY. (not primary outcome)‐ unclear whether the numbers presented are mean and SD.

Data not extracted for meta‐analysis.

Bally 2003

RCT; 2 parallel groups.

DESCRIPTION: 107 patients undergoing diagnostic coronary angiography or a percutaneous intervention procedure, in Ontario, Canada.
NUMBERS: Music group = 56 patients, Control group = 51 patients.
AGE, mean (SD): Music group = 59 (11), Control group = 58 (11).
GENDER (Male/Female): at enrolment: Music group = 34/24, Control group = 30/25.
ETHNICITY: not specified.
INCLUSION CRITERIA: 1st time diagnostic coronary angiography or a percutaneous intervention procedure, speak and read English, cognitively orientated.
EXCLUSION CRITERIA: major auditory deficits.

MUSIC GROUP: patient selected music (classical, soft rock, relaxation, country, own/other) played via headphones before, during, and after procedure, continued as the patient desired.
CONTROL GROUP: standard care (no music).

ANXIETY: State Anxiety via STAI pre and post procedure;
PAIN INTENSITY: measured via 100mm VAS pre and post procedure (data extracted);
PAIN RATING: measured via VRS pre and post procedure;
APICAL HR (bpm): measured via cardiac monitor;
BP (mm Hg): measured via pressure dynamometer and arterial pressure monitoring;
HR and BP were taken at 4 points: (1) baseline; (2) after sheath insertion; (3) end of procedure; (4) after procedure, before sheath removal. Not enough information provided for data extraction of HR and BP.

See Cepeda 2006 for details on music for pain relief.

Barnason 1995/1996

RCT; 3 parallel groups.

DESCRIPTION: 96 in‐patients in the cardiovascular ICU and progressive care units having undergone elective coronary artery bypass grafting, in USA.
NUMBERS: Music group = 33, Music+video group = 29, Scheduled rest group = 34.
AGE, mean (SD): 67 (9.9) years old.
GENDER (male/female): 65/31.
ETHNICITY: White = 96 (100%)
INCLUSION CRITERIA: Orientated to person, time and place; speak and read English; 19 years or older; extubated within 12 hours of surgery; removal of intra‐aortic balloon pump within 12 hours of surgery.
EXCLUSION CRITERIA: Currently using one of the intervention techniques; major hearing deficit.

MUSIC GROUP: Choice of 5 tapes: 'Country Western Instrumental' or 'Fresh Aire' by Mannheim Steamroller, 'Winter into Spring' by George Winston, or 'Prelude' or 'Comfort Zone' by Steven Halpern. Played via headphones for 30 minutes.
MUSIC + VIDEO GROUP:
Barnason 1995 states:
Choice of 2 Steven Halpern tapes: 'Summer Wind' or 'Crystal Suite'. Each is 30 minutes of soft instrumental with visual imaging.
Zimmerman 1996 states:
Choice of three 30 minute videocassettes by Pioneer Artist ('Water's Path', 'Western Light', or 'Winter').
SCHEDULED REST: 30 minutes of rest in bed or chair, visitors and staff requested not to disturb.

2 x 30 min intervention periods during afternoons of post‐operative days 2 and 3. Lights dimmed.

Barnason 1995 reports:
STATE ANXIETY: measured using STAI at three time‐points: pre‐operatively, before intervention on 2nd post‐operative day, and after intervention on 3rd post‐operative day.
ANXIETY: taken using NRS before and after each intervention session.
PHYSIOLOGICAL: HR (bpm) and BP (mm Hg) taken using the Kendall BP Monitor (Model 8200)‐ not enough data presented for extraction.
MOOD: Measured using a NRS‐ not a validated outcome.

Zimmerman 1996 reports:
PAIN: Pain was measured with a 10‐point VRS before and after each session, and with the McGill Pain Questionnaire (scores are given for the subscales and the present pain index rating scale) administered once prior to the first session, and once after the second session.
SLEEP: Measured with the Richards‐Campbell Sleep Questionnaire (RSQ), administered between 7am and 9am on the third post‐operative day.

Data extracted for state anxiety (STAI measure).

Patients in the music group showed a significant improvement in mood after the 2nd intervention when controlling for pre‐intervention mood rating. No differences between groups were found for anxiety on either data collection tool. Physiological measures did not differ between groups, however there were significant differences over time (regardless of group), indicating a generalised relaxation response.

Authors conclude that although no intervention was overwhelmingly superior, all groups demonstrated a relaxation response.

See Cepeda 2006 for details on music for pain relief.

Binnings 1987

RCT; 2 parallel groups.

DESCRIPTION: 20 patients undergoing regional anaesthesia in North Carolina, USA.
NUMBERS: 10 patients in each group.
AGE: Not stated.
GENDER: Not stated.
ETHNICITY: Not stated.
INCLUSION CRITERIA: Patients scheduled for regional anaesthesia, 18‐65 years old.
EXCLUSION CRITERIA: Taking tranquilizers or psychoactive medication.

NATURE TAPES: choice of sounds of birds, the ocean, a lagoon, or deeply resonant chimes, played for the duration of the surgery.
CONTROL: standard care.

STATE ANXIETY: STAI administered pre‐operatively and one hour post‐operatively to calculate the change score.
SEDATION MEDICATION: amount of Methohexital (mg) and Fentanyl (cc) administered by the anaesthetist was recorded. The anaesthetist was instructed to administer as much sedation as needed for a safe and comfortable experience with regional anaesthesia. Data extracted for Fentanyl for analysis ( P < 0.025 for differences between groups for both medications in favour of nature sounds).

Scores given for state anxiety are outside of the normal range for this questionnaire (20‐80). Method of calculating scores is not described.

SDs calculated from t‐values presented for the difference in means between groups.

Blankfield 1995

RCT; 3 parallel groups.

DESCRIPTION: 95 in‐patients undergoing coronary artery bypass (n = 92) or valvular heart surgery (n = 3) in Ohio, USA.
NUMBERS: Music group = 32, Control group = 29, therapeutic suggestions = 34.
AGE, mean (SD): Music group = 60 (10.4), Control group = 65 (7.8) years old.
GENDER (male/female): Music group = 23/9, Control group = 21/8.
ETHNICITY (White/other): Music group = 30/2, Control group = 27/2.
INCLUSION CRITERIA: All coronary artery bypass patients.
EXCLUSION CRITERIA: Impaired hearing, poor comprehension of English.

TAPED THERAPEUTIC SUGGESTIONS: excluded from review.
MUSIC GROUP: Listened to "Dreamflight II" by Herb Ernst intraoperatively and for 30 minutes twice daily during post‐operative period.
CONTROL GROUP: Listened to a blank tape intraoperatively (to blinded surgeon), and received no tape during the post‐operative period.

POST‐OPERATIVE STAY (days); Data extracted for analyses.
SURGICAL INTENSIVE CARE UNIT STAY (days); Data not entered into analyses as accounted for by postoperative stay score (no significant differences).
MORPHINE USAGE (mg);
MEPERIDINE USAGE (mg);
MORPHINE EQUIVELENTS (mg): combined morphine/meperidine usage, where the use of 10 mg of meperidine was considered equivalent to 1 mg morphine.
ORAL NARCOTICS (total number of pills);
DEPRESSION: 7‐item depression scale, unclear validity/reliability. Questionnaire given approximately one month after discharge.
ACTIVITIES OF DAILY LIVING (10‐item scale), Questionnaire given approximately one month after discharge;
CARDIAC SYMPTOM SCALE (7‐item scale), unclear validity/reliability. Questionnaire given approximately one month after discharge.

See Cepeda 2006 for details on music for pain relief.

Broscious 1999

RCT: 3 parallel groups.

DESCRIPTION: 156 in‐patients undergoing chest tube removal after open heart surgery in Virginia, USA.
NUMBERS: Music group = 70 patients, White noise = 36 patients, Control group = 50 patients.
AGE, mean (SD): 66.35 (9.7) year old.
GENDER (male/female): Music group = 53/17, White noise = 22/14, Control group = 32/18.
ETHNICITY (White/Asian/Hispanic/Other): 152/1/1/2.
INCLUSION CRITERIA: Ability to read and understand English, haemodynamic stability, no prior untoward response to music.
EXCLUSION CRITERIA: Psychiatric history.

MUSIC GROUP: Patients preselected music they would prefer to hear from a library of 10 pre‐recorded music cassettes with no lyrics. Cassettes were produced by students in a music therapy programme under the supervision of a music therapist. Patients listened to the music via headphones for 10 minutes prior to and then during chest tube removal.
WHITE NOISE: Pre‐recorded tape selected by the investigator. Patients listened to the tape via headphones for 10 minutes prior to and then during chest tube removal.
CONTROL: Not explicit, presumably standard care with no headphones.

PAIN INTENSITY: Measured using a 10 cm NRS at 3 time points: (1) 10 minutes prior to chest tube removal, (2) immediately after chest tube removal, (3) 15 minutes after chest tube removal.
HR and BP: measured every 5 minutes from 10 minutes prior to chest tube removal to 15 minutes afterwards. Physiological measurements were taken with a Hewlett‐Packard Component Monitoring System or a DINAMAP.

Report states that 18 participants had missing physiological data. Unclear from which groups these belonged, so for purposes of data extraction, it has been assumed that 6 participants were missing from each group.

See Cepeda 2006 for details on music for pain relief.

Buffum 2006

RCT; 2 parallel groups.

DESCRIPTION: 170 pre‐operative patients to undergo vascular angiography in California, USA.
NUMBERS: Music group = 89, Control group = 81.
AGE, mean (SD): 66.8 (9.95) years old.
GENDER (male/female): 166/4.
ETHNICITY: not described.
INCLUSION CRITERIA: undergoing vascular angiography of the abdomen or lower extremities; 18 years or older; English speaking; read and write a 5th grade level; able to sign consent; interested in participating.
EXCLUSION CRITERIA: Documented diagnosis of active psychosis or dementia; unable to consent; could not listen to music for 15 minutes prior to procedure.

MUSIC GROUP: Selection of 5 categories (classical, jazz, rock, country western, easy listening), played via headphones for 15 minutes prior to angiography. Patients could continue to listen to music during the angiography after collection of outcomes.
CONTROL GROUP: 15 minute wait period. These participants were allowed to listen to music during the angiography after the study outcome measures had been taken.

ANXIETY: Measured via STAI before and after 15 minute study period.
VITAL SIGNS: Unclear how data collected.

Cadigan 2001

RCT; 2 parallel groups.

DESCRIPTION: 140 in‐patients in the cardiac units with intravascular sheaths or an intra‐aortic balloon pump (IABP) in place, in USA.
NUMBERS: Music group = 75 patients, Control group = 65 patients.
AGE, mean (SD): Music group = 62 (11.4), Control group = 62.5 (14).
GENDER (Male/Female): Music group = 56/19, Control group = 44/21.
ETHNICITY: not specified.
INCLUSION CRITERIA: read and speak English, haemodynamic stability, received an intravascular sheath or IABP.
EXCLUSION CRITERIA: psychiatric illness, hearing deficits (not enhanced with an assistive device), documented confusional state.

MUSIC GROUP: 30 minutes of music through headphones. Mixture of symphonic music and nature sounds selected by the researchers. Same music played to all those in the music group.
CONTROL GROUP: standard care.

PAIN PERCEPTION: measured via 10 mm VAS pre‐ and post‐intervention.
HR (bpm): determined from a 1 minute readout of electrocardiogram;
BP: measured via noninvasive automatic oscillometric BP cuff or transduced arterial wave form;
RR (breaths per minute): measured via auscultation with stethoscope over chest for 1 minute;
PERIPHERAL SKIN TEMPERATURE: taken from index finger with 'Dermatemp' hand‐held infrared thermographic scanner;
MOOD: measure by the Profile of Mood States (POMS) short form questionnaire.

See Cepeda 2006 for details on music for pain relief.

Cepeda 1998

RCT; 2 parallel groups.

DESCRIPTION: 193 day‐patients undergoing lithotripsy for renal stones (America).
NUMBERS: Music group = 97, Control group = 96 patients.
AGE, mean (SD): Music group = 40.7 (12.1), Control group = 41.0 (11.4).
GENDER (male/female): Music group = 48/49, Control group = 47/49.
ETHNICITY: not described.
INCLUSION CRITERIA: 15‐65 years old, undergoing first lithotripsy for renal stones.
EXCLUSION CRITERIA: Serum creatinine exceeded 1.5 mg/dl.

MUSIC GROUP: Music of type preferred by patient played via headphones, starting 10 minutes prior to procedure and continuing until 10 minutes after lithotripsy is complete. Patients wore additional ear protectors to protect patients from the noise of the lithotriptor.
CONTROL GROUP: Wore headphones with ear protectors however the music (of patient preference) did not begin until the lithotripsy and study primary outcomes data collection had completed. Music was played for 10 minutes at the conclusion of the procedure.

PAIN INTENSITY: rated verbally every 5 minutes throughout the lithotripsy on a NRS (0‐10).
ALFENTANIL REQUIREMENT: "registered" (mg).
QUALITY OF ANALGESIA: rated by anaesthesiologist on a 4‐point scale (excellent to bad), 10 minutes after procedure conclusion.
SIDE EFFECTS: evaluated throughout procedure and in the PACU: respiratory depression, bradycardia, level of consciousness, nausea, pruritis.
PATIENT SATISFACTION WITH ANALGESIA: patient rated before leaving the PACU on a VRS, and indicated if they would accept same technique for future treatments.

See Cepeda 2006 for details on music for pain relief.

Chan 2003

RCT; 2 parallel groups.

DESCRIPTION: 220 female out‐patients undergoing colposcopy in China.
NUMBERS: Music group = 112 patients, Control group = 108.
AGE, median (range): Music group = 40 (20‐61), Control group = 38.5 (19‐65).
GENDER: All patients were female.
ETHNICITY: All patients were Chinese.
INCLUSION CRITERIA: 18‐65 years old, presenting for initial colposcopy, read and understand Chinese.
EXCLUSION CRITERIA: previous experience of colposcopy, mental impairment, pregnant.

MUSIC GROUP: CD compilation of slow‐rhythm music (instrumental ballad). Patients could choose to listen to any song(s) within the compilation. Music played through speakers during the examination. Prior to onset of study women attending the clinic were surveyed on musical preferences to inform compilation disc.
CONTROL GROUP: standard care, no music.

ANXIETY: State anxiety via Chinese version of STAI measured pre and post colposcopy;
PAIN INTENSITY: measured via 10 cm VAS.

See Cepeda 2006 for details on music for pain relief.

Chan 2006

RCT; 2 parallel groups.

DESCRIPTION: 43 in‐patients undergoing application of a C‐clamp (which applies pressure to stop bleeding when sheaths are removed after percutaneous coronary interventions), in an ICU, Hong Kong, China.
NUMBERS: Music group = 20, Control group = 23.
AGE: 32.6% of participants were 75+, age ranged from 35 upwards.
GENDER (male/female): Music group = 16/4, Control group = 15/8.
ETHNICITY: not described.
INCLUSION CRITERIA: Diagnosis of MI, acute coronary syndrome, or coronary artery disease; conscious and alert; able to communicate, read, and write; able to speak Cantonese.
EXCLUSION CRITERIA: hearing deficit; history of psychiatric illness; neurological disorders; dying; unable to give informed consent.

MUSIC GROUP: 3 choices of soft, slow music without lyrics (slow rhythmic songs, Chinese slow rhythmic music, Western slow rhythmic music). Music played via headphones during the application of the C‐clamp (approximately 45 minutes).
CONTROL GROUP: No music, standard care.

VITAL SIGNS: BP, HR, RR, and oxygen saturation, recorded at baseline, 15, 30, and 45 minutes via a bedside monitor.
PAIN: Measured via the Universal Pain Assessment Tool (a NRS).

Outcomes extracted for end time‐point only.

This paper states that missing values (unclear how many) were replaced with the group mean. It is unclear from the data presented if these are the raw values, or those that have been adjusted (which may potentially bias the results by lowering the variance and exaggerating group differences). For this reason we have removed this study in sensitivity analyses.

See Cepeda 2006 for details on music for pain relief.

Chang 2005

RCT; 2 parallel groups.

DESCRIPTION: 64 patients undergoing cesarean section in Taiwan.
NUMBERS: 32 patients per group.
AGE, mean (SD): Music group = 30.31 (4.16), Control group = 32.31 (4.48) years old.
GENDER: Female = 64 (100%) .
ETHNICITY: Taiwanese.
INCLUSION CRITERIA: Women scheduled to receive cesarean section; married, between 20 and 40 years old; pregnancies gone to term with planned cesarean births; underwent spinal or epidural anaesthesia; newborns normal singletons with an Apgar score >/= 7 at 5 minutes.
EXCLUSION CRITERIA: not stated.

MUSIC GROUP: Choice of western classical, new age, or Chinese religious music, played via headphones. Participants listened to music for at least 30 minutes from start of anaesthesia to end of surgery. Volume low enough to allow mutual conversation with the researcher.
CONTROL GROUP: Unaware they had not had the opportunity to listen to music. They received the researchers' attendance and casual conversation.

ANXIETY: measured via a 10 cm VAS, researcher filled it in after asking participant to indicate how they were feeling.
PHYSIOLOGICAL MEASURES: Oxygen saturation (measured via NONIN MODEL 9500 pulse oximeter), temperature of finger (measured via biofeedback system DT‐002), RR, pulse, and BP measured via Hewllett Packard 78352A.
BIRTH SATISFACTION: measured via the satisfaction of cesarean delivery scale (SCDS) designed for the present study. Data not extracted.

Anxiety & physiological measures taken pre‐surgery, post neonatal contact, and after completion of skin suture. Data extracted for end time‐points only.

Chlan 1995

RCT; 2 parallel groups.

DESCRIPTION: 20 in‐patients receiving mechanical ventilation in private patient room areas in critical care units in Midwest USA.
NUMBERS: Music group = 11, Control group = 9.
AGE, mean: Music group = 64.2, Control group = 55.7 years old.
GENDER (male/female): 13/7.
ETHNICITY: not described.
INCLUSION CRITERIA: mechanically ventilated patients; alert; mentally competent; haemodynamically stable; able to sign consent form; adequate hearing.
EXCLUSION CRITERIA: Documented mental incompetence; haemodynamically unstable; comatose; uncorrected impaired hearing.

MUSIC GROUP: Selection of classical music played for 30 minutes via headphones. Patients instructed to close eyes and concentrate on the music.
CONTROL GROUP: Wore headphones with no music. Instructed to close eyes and rest for 30 minutes.

For both groups lights were dimmed and/or doors closed. Experiment took place during late afternoon or early evening.

MOOD: Short‐form POMS.
PHYSIOLOGICAL: HR (bedside ECG monitor), RR (observation for 1 minute), Oxygen saturation (pulse oximetry with finger probe), airway pressure (dial on ventilator), and BP (indwelling arterial lines, automatic BP monitor, or mercury sphygmomanometer and stethoscope), were measured before, and at 5 minute intervals during and 5 minutes after the intervention for both groups.

No SDs are presented for the post‐intervention physiological outcomes. Significant differences were found for HR and RR in favour of music. Other variables did not differ significantly.

Chlan 1998

RCT; 2 parallel groups.

DESCRIPTION: 54 in‐patients receiving mechanical ventilation in one of 4 Intensive Care Units, USA.
NUMBERS: 27 patients in each group.
AGE, mean (SD): Music group = 57.3 (14.5); Control = 56.8 (18.6).
GENDER (Male/Female): 22/32.
ETHNICITY (White/Black/Native American): 50/3/1.
INCLUSION CRITERIA: ventilator dependent, alert, mentally competent, adequate hearing, English as primary language.
EXCLUSION CRITERIA: receiving continuous intravenous sedation.

MUSIC GROUP: choice of non‐lyric tapes 60‐80 bpm, classical, new age, country western, religious, and easy listening (30 mins).
CONTROL GROUP: rest period (30 mins).
Both groups received an enhanced environment by closing the blinds, placing a "do not disturb" sign on door, dimming the lights, and instructed to lie quietly and close eyes.

ANXIETY: State anxiety via short form STAI (6 items);
RR (observation);
HR (bedside cardiac monitor).

Insufficient data for RR and HR data extraction.

Due to the lack of clarity over withdrawals and drop‐outs, it is unclear how many people were analysed in each group for the outcome anxiety. The degrees of freedom stated (49) suggests 51 observations were made, and we have assumed that N = 25 in the music group and N = 26 in the control group, based on the descriptions given for 3 of the withdrawals in the paper.

Chlan 2000

RCT; 2 parallel groups.

DESCRIPTION: 64 out‐patients undergoing flexible sigmoidoscopy (FS) in Midwest USA.
NUMBERS: Music group = 30 patients; Control group = 34 patients.
AGE, mean (SD): Overall = 54.6 (11.5) years old.
GENDER (Male/Female):20/44
ETHNICITY (White/African‐American/Hispanic): 62/1/1.
INCLUSION CRITERIA: any adult out‐patient scheduled to undergo a nurse‐endoscopist performed screening FS, English as primary language, adequate or corrected hearing, mental competence.
EXCLUSION CRITERIA: mentally incompetent (i.e. Alzheimers), uncorrected hearing impairment, English not primary language.

MUSIC GROUP: choice of music (classical, country‐western, new‐age, easy listening, pop, rock, religious, jazz, era‐specific, motion picture soundtracks), played via headphones during FS procedure. Patients instructed to concentrate on music and that the investigator would meet with them afterwards to discuss their experiences.
CONTROL GROUP: routine care consisting of nurse‐endoscopist speaking to the patient at various times throughout the procedure. Patients were informed that the investigator will meet with them afterwards to discuss their experiences.

ANXIETY: State anxiety measured via STAI
DISCOMFORT: Intensity of discomfort measured via NRS (entered into review as pain scores).
SATISFACTION: Satisfaction measured via VRS
FUTURE COMPLIANCE: Perceived future compliance measured via VRS

Chui 2003

RCT; 2 parallel groups.

DESCRIPTION: 68 pre‐operative patients undergoing extracorporeal shock wave lithotripsy (ESWL) in Taiwan.
NUMBERS: Music group = 34 patients, Control group = 34 patients.
AGE (range): 23‐72 years old.
GENDER (male/female): 57/11.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: listened to natural music via headphones for 5 minutes prior to ESWL.
CONTROL GROUP: Headphones without music for 5 minutes.

All participants lay on the operating table and rested in the dark alone. Then experimental conditions were implemented and the outcome measures were taken, all prior to ESWL procedure.

BLOOD PRESSURE: Method of data collection unclear.
HEART RATE VARIABILITY: Measured via an electrocardiogram (ECG). A number of measures derived, including RR intervals, low frequency (LF) and high frequency (HF) bands, converted into total power (LF nu; HF nu) and the LF/HF ratio.

Heart rate variability data showed positive changes in favour of the music group.

Colt 1999

RCT; 2 parallel groups.

DESCRIPTION: 60 in‐patients and out‐patients undergoing flexible fibreoptic bronchoscopy (FB) in California, USA.
NUMBERS: Music group = 30 patients; Control group = 30 patients.
AGE, mean (SD): Music group = 49 (18); Control group = 56 (13) years.
GENDER (Male/Female): Music group = 20/10; Control group = 19/11.
ETHNICITY (Caucasian/Hispanic/Black/Asian): 37/11/10/2.
INCLUSION CRITERIA: All in‐patients and out‐patients referred for diagnostic FB.
EXCLUSION CRITERIA: under 18 years old, unable to speak and understand English, unable to give consent, in need of ICU hospitalisation, significantly hearing impaired, impaired mental status, receiving known anxiolytic or sedative medication.

MUSIC GROUP: "Relax" (Expansion Records, Manchester, UK) consisting of piano improvisations (60bpm), played via headphones during FB procedure.
CONTROL GROUP: silence whilst wearing headphones during FB procedure.

ANXIETY: State and Trait anxiety measure via STAI.

Cooke 2005

RCT; 3 parallel groups.

DESCRIPTION: 180 pre‐operative day patients scheduled for day surgery in Australia.
NUMBERS: 60 participants in each group.
AGE, median (range): Music group = 53 (19‐99), Placebo group = 58 (18‐83), Control group = 56 (18‐87) years old.
GENDER (male/female): 30/30 in each group.
ETHNICITY: not described.
INCLUSION CRITERIA: Day surgery patients.
EXCLUSION CRITERIA: < 18 years old; undergoing eye surgery requiring eye drops which could affect vision; had pre‐operative sedatives; did not like music; hearing‐impaired; difficulty wearing headphones; could not read and write English; had a pre‐operative waiting time anticipated as < 45 minutes.

MUSIC GROUP: Choice of classical, jazz, country & western, new age, easy‐listening, and "other" mostly by contemporary artists. Music played for 30 minutes via headphones.
PLACEBO GROUP: Patients wore headphones without any music for 30 minutes.
CONTROL GROUP: Routine care.

ANXIETY: State anxiety measured via STAI.

95% Confidence Intervals are presented in the paper based on logarithmically transformed scores. Standard deviations were calculated by first back‐translating data to a log scale before utilising the CIs to estimate the SDs. Data entered into the review analysis are expressed as the natural log.

Cruise 1997

RCT; 4 parallel groups.

DESCRIPTION: 121 patients undergoing elective cataract extraction in Canada.
NUMBERS: Music = 32, OR noise = 30, White noise = 29 (Relaxing Suggestions, N = 30, excluded from review).
AGE, mean: Music = 70.8, OR noise = 68.3, White noise = 73.6 years old.
GENDER (male/female): Music = 8/24, OR noise = 12/18, White noise = 12/17.
ETHNICITY: not described.
INCLUSION CRITERIA: none described.
EXCLUSION CRITERIA: On sedative or psychotropic drugs; hearing impairment.

MUSIC GROUP: Classical music accompanied by soothing sounds of nature, played via headphones intra‐operatively.
OR NOISE: Playback of a previously recorded cataract operation, played via headphones intra‐operatively.
WHITE NOISE: Played via headphones intra‐operatively.
RELAXING SUGGESTIONS: Excluded from review.

ANXIETY: Measured via STAI before and after surgery.
VITAL SIGNS: BP, HR, and RR recorded before and after the retrobulbar block, and at 15 minute intervals thereafter until procedure completion.
SATISFACTION: Unclear validity, not included in review.

Data reporting unclear. Cannot extract SDs.

No differences between groups are reported for anxiety, DBP, HR and RR.

SBP did differ between groups over time, where music and white noise groups increased more after the retrobulbar block than the OR noise group, and then the OR noise group decreased more over the course of the operation than both the music and white noise group. Exact differences between groups are unclear.

Daub 1988

RCT; 3 parallel groups.

DESCIPTION: 90 pre‐operative in‐patients waiting for dental restoration surgery under general anaesthesia, or orthopedic surgery, in Germany.
NUMBERS: 30 patients in each group.
AGE: 15‐65 years old.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: 15‐65 years old; German speaking (1st language).
EXCLUSION CRITERIA: Malignant diseases; expecting operations of uncertain outcome.

MUSIC GROUP: listened to 45 minutes of music pre‐operatively. Choice of music arranged the evening before surgery. 11 patients chose classical, 19 chose pop music.
NO MEDICATION: Patients received no premedication and no music.
MEDICATION: Received 1‐2 ml Thalamonal. Excluded from review.

ANXIETY: Measure via STAI and a tick‐box anxiety scale tailored for the clinic. There was a significant decrease in state anxiety from pre‐treatment to post‐treatment in the music group (change score = 2.2). There was no significant change in anxiety for the 'no medication' control group (change score = 0.633).

Other outcomes not included.

Not enough information for data extraction.

Davis‐Rollans 1987

RCT; Cross‐over study.

DESCRIPTION: 24 in‐patients with MI (N = 12) and other cardiac conditions (N=12) in a Critical Care Unit, Ontario, Canada.
NUMBERS: Cross‐over study of 24 patients.
AGE, mean (range): 62 (45‐75) years old.
GENDER (male/female): 19/5.
ETHNICITY: not described.
INCLUSION CRITERIA: Willingness to listen to music; Asymptomatic for 6 hours prior to data collection; Stable vital signs; Physician's approval to participate.
EXCLUSION CRITERIA: Pace‐maker; Hearing deficit; Use of a ventilator; Asian or Middle Eastern cultural background [rationale: "tonal systems differ from that of Western (European) music"].

MUSIC: 3 pieces each lasting approximately 12 minutes played in randomised Latin square design via headphones. a) Symphony no.6 by Beethoven; b) Eine Kleine Nachtmusik by Mozart; and c) The Moldau by Smetana.
CONTROL: ICU noise as heard through silent headphones.

Order of receiving conditions was randomised, each condition lasted 42 minutes.

PSYCHOLOGIC: Questionnaire not fully validated (content validity only). Not extracted for review.
PHYSIOLOGICAL: HR (median values used) and heart rhythm (clinical categorisation) measured via electrocardiography. RR measured via Brush‐Gould bellows pneumograph and Hewlett‐Packard 4 channel FM tape recorder.

Each session began with a 5 minute baseline data collection period.

Significant order effects for HR variability (P = 0.03) and heart rhythm (ectopy).

HR varied when different music pieces were played (P = 0.04) regardless of order.

Individual patient data presented for HR during music and control periods. Data extracted for review and paired t‐test reveals no significant difference between groups (MD = 0.847, 95% CI = ‐1.42, 3.11, P = 0.447), music and control significantly correlated (r = 0.942). Data entered with adjusted standard deviations.

No significant differences are reported for RR between music and control periods.

Domar 2005

RCT; 3 parallel groups.

DESCRIPTION: 143 out‐patients (93 included in present review) undergoing screening mammography in a clinic of a tertiary care hospital in Massachusetts, USA.
NUMBERS: Music group = 47, Control group = 46 patients.
AGE, mean (SD): Music group = 51.7 (10.9), Control group = 53.1 (11.6).
GENDER: all patients were female.
ETHNICITY (white/black/other): Music group = 91/7/2, Control group = 80/13/7.
INCLUSION CRITERIA: Scheduled for screening mammography.
EXCLUSION CRITERIA: unable to read and speak English, current psychiatric diagnosis, brought own tape player and planned to listen to an audiotape during mammography, pain or anxiety medication taken before procedure. Additionally stated "women who have a history of breast cancer do not undergo screening, so they were not eligible for the study".

RELAXATION GROUP: excluded from review, as taped instructions constitute a psychological therapy.
MUSIC GROUP: choice of classical, jazz, or soft rock, played via headphones whilst in the waiting room and during the examination.
CONTROL GROUP: blank tape played via headphones, whilst in the waiting room and during the examination.

ANXIETY: recorded before and after study period using the STAI, and at the end of the study with a Likert scale (1‐10) asking to rate level of anxiety felt during the procedure.
PAIN: recorded after procedure using the McGil Pain Questionnaire, and a Likert scale (1‐10) asking to rate pain felt during the procedure.

Investigator identified a possible floor effect.

See Cepeda 2006 for details on music for pain relief (this study is not yet included in Cepeda 2006).

Elliot 1994

RCT; 3 parallel groups.

DESCRIPTION: 56 in‐patients with unstable angina pectoris or acute MI at coronary care unit in Australia.
NUMBERS: Music group = 19, Control group = 19, muscle relaxation not included in review.
AGE, average = 60.6 years old.
GENDER (male/female): 40/16.
ETHNICITY (Australian/Other): 47/9.
INCLUSION CRITERIA: Patients admitted to the coronary care unit with provisional medical diagnoses of unstable angina pectoris or acute MI.
EXCLUSION CRITERIA: none further described.

MUSIC GROUP: Received two or three 30‐minute sessions of light classical music (Bonny,Music Rx) played via headphones.
CONTROL GROUP: two or three sessions of 30 minutes uninterrupted rest.
MUSCLE RELAXATION: Excluded from review.

ANXIETY: Measured at pre and post test with three psychologic scales, 1) STAI, 2) Hospital Anxiety and Depression Scale, and 3) Linear Analogue Anxiety Scale (VAS). STAI scores extracted for review.
PHYSIOLOGICAL: HR (measured digitally by bedside cardiac monitors) and BP (measured via sphygmomanometer) were observed 7 times at the routine observation times in the coronary care unit (not directly before and after intervention period).

Ezzone 1998

RCT; 2 parallel groups.

DESCRIPTION: 33 in‐patients undergoing bone marrow transplant chemotherapy, in Columbus, USA.
NUMBERS: Music group = 16, Control group = 17.
AGE, median (range): Music group = 36.9 (21‐49), Control group = 40.3 (14‐61).
GENDER (male/female): Music group = 11/5, Control group = 8/9.
ETHNICITY: not described.
INCLUSION CRITERIA: Patients receiving treatment with autologous or allogeneic transplant; a preparative regimen consisting of busulfan and cyclophosphamide or busulfan, etoposide, and cyclophosphamide with all dosages calculated on body weight; the pharmacologic protocol for control of nausea and vomiting consisting of IV ondansetron 0.15 mg/kg every six hours around the clock starting 30 minutes before and continuing for 24 hours after the preparative regimen. Additional antiemetics were limited to IV lorazepam 1‐2 mg or promethazine 12.5‐25 mg every four to six hours as needed for breakthrough nausea and vomiting.
EXCLUSION CRITERA: none described.

MUSIC GROUP: Listened to 45 minute recording of self‐selected music via headphones at 6, 9, and 12 hours after the start of each infusion as an adjunct to antiemetic therapy. A variety of music selections was available and patients were encouraged to bring their favourite music.
CONTROL GROUP: Standard care.

NAUSEA: Measured on a VAS in the pictorial form of a thermometer (questionable validity).
Mean (range) at 8‐hour follow‐up, 1st dose of Cytoxan:
Music group = 50 (0‐90), Control group = 54.4 (0‐100)
Mean (range) at 8‐hour follow‐up, 2nd dose of Cytoxan:
Music group = 29.6 (0‐95), Control group = 59.3 (0‐100).
VOMITING: Instances of vomiting were defined as the oral expulsion of gastric contents or as retching, the act of vomiting without expulsion of gastric contents. For data analysis, the authors considered the occurrence of 5 instances of retching within one minute as a vomiting episode.
Mean (range) episodes at 8‐hour follow‐up, 1st dose:
Music group = 0.69 (0‐4), Control group = 1.73 (0‐6)
Mean (range) episodes at 8‐hour follow‐up, 2nd dose:
Music group = 0.31 (0‐2), Control group = 0.94 (0‐2).

Data not in sufficient detail for extraction.

The music group had significantly less nausea and vomiting than the control group (Mann‐Whitney U test, P < 0.017 for both comparisons).

Ferguson 2004

RCT; 2 parallel groups.

DESCRIPTION: 11 patients undergoing range‐of‐motion exercises as part of acute care rehabilitation for burns, Virginia, USA.
NUMBERS: Music group = 5, Control group = 6.
AGE, mean (range, SD): Music group = 45.4 (22‐75, 19.3), Control group = 38.3 (18‐57, 16.3).
GENDER (male/female) %: Music group = 92/8, Control group = 46/54. (Note: Can not sensibly convert % to number of patients ‐data unclear)
ETHNICITY (African American/White) %: Music group = 58/42, Control group = 0/100
INCLUSION CRITERIA: English‐speaking; partial‐thickness or deeper burns crossing at least one major joint; scored 100% on a cognitive screening tool.
EXCLUSION CRITERIA: No further criteria described.

MUSIC GROUP: Choice of 6 cassette tapes (Lifescapes series) that met the guidelines for music in medical settings. Music was played during the range‐of‐motion exercises.
CONTROL GROUP: No music played during the range‐of‐motion exercises.

The number of repetitions and type of exercise (active, active‐assistive, or passive) were based on the needs of each patient. Both groups were treated in the patient's room with the door closed and "do not disturb" sign posted. Lights were turned on and the television was turned off.

PAIN: Measured via VAS before and after rehabilitation exercises. There was a statistically significant increase in pain from pre‐treatment to post‐treatment in both groups (P = 0.04). There was no significant difference between groups (P = 0.38).
ANXIETY: Measured via STAI before and after rehabilitation exercises. The mean pre‐treatment and post‐treatment state anxiety scores were greater for the control group (P = 0.04).
VITAL SIGNS: BP, HR, and RR measured before and after rehabilitation exercises using either the Hewlett‐Packard Component Monitoring System or the Dinamap 8100 Portable Vital Signs Monitor. There were no significant differences between groups (systolic BP: P = 0.30, diastolic BP: P = 0.84, HR: P = 0.29, RR: P = 0.54). RR did increase in both groups from baseline (P <0.01).

Data not in sufficient detail for extraction.

See Cepeda 2006 for details on music for pain relief.

Gaberson 1991

RCT (post‐test only); 3 parallel groups.

DESCRIPTION: 15 pre‐operative patients in the waiting room for elective same‐day surgery in Pittsburgh, USA.
NUMBERS: Music group = 5, Control group = 5, Humour group = 5 (excluded from review).
AGE (range): 23‐76 years old.
GENDER (male/female): 6/9.
ETHNICITY: not described.
INCLUSION CRITERIA: 21 years old and over; admitted for same‐day elective surgical procedures;
EXCLUSION CRITERIA: Can not speak, understand, and read English; Hearing loss; Surgery for diagnostic procedures; Taken anti‐anxiety medication with 24 hours of operation.

HUMOUR GROUP: excluded from review.
MUSIC GROUP: Listened to 'Omni Suite' by Steven Bergman (tranquil music) via headphones for 20 minutes in the waiting room.
CONTROL GROUP: Standard care.

ANXIETY: Measured via a VAS after the intervention period.

Gaberson 1995

RCT (post‐test only); 3 parallel groups.

DESCRIPTION: 46 pre‐operative patients scheduled for same‐day surgery in Pittsburgh, USA.
NUMBERS: Music group = 16 patients, Control group = 15 patients, Humour group = 15 patients (excluded from review);
AGE, mean (SD): Music group = 51.75 (17.18), Control group = 47.07 (19.07) years old.
GENDER (male/female): 19/27
ETHNICITY: not described.
INCLUSION CRITERIA: 21 years and older; scheduled for elective surgical procedures.
EXCLUSION CRITERIA: Can not speak, read, and understand English; Hearing loss; Undergoing diagnostic procedure; Taken medications with anti‐anxiety effects within past 24 hours; presenting with ear pathology.

HUMOUR GROUP: excluded from review.
MUSIC GROUP: listened to tranquil music via earphones for 20 minutes after admission to surgery unit and before scheduled procedure.
CONTROL GROUP: 20 minute waiting period (standard care).

ANXIETY: Measure post‐intervention via VAS.

Ganidagli 2005

RCT; 2 parallel groups.

DESCRIPTION: 50 pre‐operative patients to undergo septorhinoplastic surgery in Turkey.
NUMBERS: Music group = 25, Control group = 25 patients.
AGE, mean (SD): Music group = 31 (9), Control group = 29 (9) years old.
GENDER (male/female): Music group = 14/11, Control group = 15/10.
ETHNICITY: not described.
INCLUSION CRITERIA: ASA I‐II; 18‐60 years old; scheduled to undergo septorhinoplastic surgery.
EXCLUSION CRITERIA: 4 patients excluded as observer blinding unsuccessful due to technical problems with tape player.

MUSIC GROUP: Patients brought own CD or tape from home, those who forgot were provided with a 'suitable replacement', played via headphones during pre‐operative period, as patients were being sedated.
CONTROL GROUP: Blank tape/CD played via headphones during pre‐operative sedation period.

All patients asked to bring music from home in case they were allocated to the music group.

"modified" OAA/S: not included in review.
BI‐SPECTRAL INDEX (BIS): Time (seconds) to reach BIS value of 60 (hypnotic end point of anaesthesia). BIS values were monitored (A‐2000, Aspect Medical Systems Inc) and the average scores calculated at 10 minute intervals from baseline to 50 minutes. Data extracted for time to reach BIS 60 value (end‐point).
PROPOFOL: induction dose of propofol (mg) recorded.
Time to eyelash reflex: not included in review.

Guo 2005

RCT; 2 parallel groups.

DESCRIPTION: 93 in‐patients scheduled for laparoscope surgery, in Beijing, China.
NUMBERS: Music group = 48 patients; Control group = 45.
AGE, mean (SD) years: Music group = 40.90 (10.94); Control group = 40.69 (9.94).
GENDER (male/female): Music group = 20/28; Control group = 19/26.
ETHNICITY: Not stated.
INCLUSION CRITERIA: Consenting patients.
EXCLUSION CRITERIA: Hearing problems; cancer patients; no clear outcome from laparoscopy.

MUSIC GROUP: Choice of 6 types of music (Western classical; light; pop; folk; folksong; opera) with 30 minutes listening time. Patients listened to music via headphones 1‐2 hours before their operation, whilst lying in bed.
CONTROL GROUP: Had headphones with no music for 30 minutes 1‐2 hours prior to operation.

ANXIETY: Measured via STAI before and after intervention period.
BP, HR, GALVANIC SKIN RESPONSE: Measured before intervention, at 10 and 20 minutes after, and at 4 hours after. Unclear what time point the data in the table reflects.
SALIVA CORTISOL: Measured before and 2‐3 minutes after intervention.

Harikumar 2006

RCT; 2 parallel groups.

DESCRIPTION: 78 patients undergoing colonoscopy in Kerala, India.
NUMBERS: Music group = 38, Control group = 40
AGE: not described.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: Scheduled for elective colonoscopy; 15‐60 years old.
EXCLUSION CRITERIA: Hard of hearing; overt or borderline psychiatric illness; cardiopulmonary morbidity.

MUSIC GROUP: Choice of 6 tapes played via headphones during colonoscopy. Selection of: popular film songs (based on carnatic classical ragas), classical music, devotional songs, folk songs, soft instrumental music, bioacoustics (soft instrumental music with nature sounds).
CONTROL GROUP: Wore headphones but were not played music.

SEDATION: Dose of midazolam (2 mg given on demand).
DURATION OF PROCEDURE;
RECOVERY TIME: Defined as when patient orientated in time, place, and person, and can serially subtract 6 from 100, as assessed by recovery room nurse;
PAIN SCORE: 0‐10 visual analogue scale (UNCLEAR if patient or nurse rated);
DISCOMFORT SCORE: 0‐10 visual analogue scale (UNCLEAR if patient or nurse rated);
WILLINGNESS TO REPEAT PROCEDURE: Method of data collection not described.

Data insufficient for extraction.

Data reported as median and range.

Controls received significantly more midazolam:
Music group = 4 (0‐6) mg
Control group = 5 (0‐8) mg

Duration of procedure did not differ between groups:
Music group = 28 (14‐50) minutes
Control group = 33 (17‐58) minutes

Recovery time was significantly longer in controls:
Music group = 10 (0‐28) minutes
Control group = 20 (0‐20) minutes.

See Cepeda 2006 for details on music for pain relief (this study is not yet included in Cepeda 2006).

Hayes 2003

RCT; 2 parallel groups.

DESCRIPTION: 198 out‐patients awaiting gastrointestinal procedures (colonoscopy or esophagogastroduodenoscopy [EGD]) in California, USA.
NUMBERS: Music group = 100, Control group = 98.
AGE, mean (SD): 61 (10.5) years old.
GENDER (male/female): 193/5.
ETHNICITY: not described.
INCLUSION CRITERIA: Undergoing colonoscopy or EGD for the 1st time; 18 years or older; English speaking; Able to read at 5th grade level; able to sign the study consent.
EXCLUSION CRITERIA: Actively psychotic or has dementia; could not listen to music for 15 minutes prior to procedure.

MUSIC GROUP: Patient selected music (classical, rock, jazz, country western, easy listening) for 15 minutes prior to medical procedure. Were allowed to continue listening to music after outcome measures were taken.
CONTROL GROUP: No music for a 15 minute wait, were given the opportunity to listen to music during their procedure.

ANXIETY: state anxiety measured via STAI.
PHYSIOLOGICAL MEASURES: BP and pulse were recorded before and after the 15‐minute intervention period, however details of methods unclear.

This study has questionable clinical relevance: "To avoid introducing more anxiety with the explanation of the [gastrointestinal] procedure, the consent process for the [gastrointestinal] procedure was delayed until after the patients completed the music study".

Heitz 1992

RCT; 3 parallel groups.

DESCRIPTION: 60 in‐patients who have undergone surgery with general anaesthesia, in a PACU in Iowa, USA.
NUMBERS: 20 participants per group.
AGE, mean (SE): Music group = 46 (3), Control group = 52 (3), Headphones only group = 54 (4) years old.
GENDER (male/female): Music group = 2/18, Control group = 1/19, Headphones only group = 1/19.
ETHNICITY: not described.
INCLUSION CRITERIA: >19 years old; Undergoing a thyroidectomy, parathyroidectomy, or unilateral modified radical mastectomy; Intact hearing; No drug abuse; No psychiatric history; class I‐III ASA status.
EXCLUSION CRITERIA: none further described.

MUSIC GROUP: Choice of three instrumental tapes: Calm classical (e.g. Bach, Debussy, Pachelbel), Stimulative classical (e.g. Strauss, Tschaikovsky), and calm popular music (e.g. piano solos by George Winston, guitar solos by William Ackerman and Steve Halpern). Patients decided which music they would like to listen to in the PACU in the pre‐operative visit. Played via headphones until discharge from PACU.
CONTROL GROUP: No headphone, no music (standard care).
HEADPHONES ONLY GROUP: Wore headphones but heard no music. Patients wore headphones until discharge from the PACU.

PAIN: Measured via 10cm VAS every 15 minutes while in the PACU.
MORPHINE REQUIREMENT: Patients received 0.025 mm/kg IV morphine every 5 minutes as necessary for pain control. Total requirement and time until initial analgesic was needed after leaving the PACU were recorded.
PHYSIOLOGICAL MEASURES: BP and HR were monitored with an ECG and Noninvasive BP machine (Spacelabs, Redmond, WA). RR was monitored by counting the rate for 1 minute. BP, HR, and RR were recorded every 15 minutes whilst in the PACU.
LENGTH OF STAY: Length of stay in the PACU was recorded.
FOLLOW‐UP QUESTIONNAIRE: not included in review (not validated).

Data insufficient for extraction.

There was no significant differences between groups in:
Pain scores; Morphine requirement; BP; HR; RR; Length of stay.

After leaving the PACU patients in the music group (mean = 6.5 hours) waited significantly longer than the headphones only group (mean = 3.5 hours) before initially requiring analgesic. Patients in the control group waited for 4.5 hours (not significant).

See Cepeda 2006 for details on music for pain relief.

Ikonomidou 2004

RCT; 2 parallel groups.

DESCRIPTION: 55 day‐patients undergoing laparoscopic sterilization or laparoscopic tubal dyeing as part of a fertility programme in Sweden.
NUMBERS: Music group = 29, Control group = 26.
AGE, median (range): Music group = 34 (25‐45), Control group = 34 (22‐42) years old.
GENDER: Female = 55 (100%).
ETHNICITY: not described.
INCLUSION CRITERIA: ASA rating 1‐2; 25‐45 years old (does not tally with baseline characteristics); scheduled to undergo gynaecologic laparoscopy under general anaesthesia.
EXCLUSION CRITERIA: ASA rating > 2; psychiatric disorder; history of drug/alcohol abuse; neurological disease; 1st language not Swedish; chronic pain problems; analgesic medication taken within the last week; allergy to any of the planned perioperative medications; past complications during anaesthesia or surgery; additionally 5 patients were excluded from analysis due to "extended surgery or various technical problems on the ward"

MUSIC GROUP: Panpipe music played via headphones for 30 minutes pre‐operatively and 30 minutes post operatively.
CONTROL GROUP: Blank disc and headphones for 30 minutes pre‐ and post‐operatively.

PHYSIOLOGICAL MEASURES: RR, BP, and HR, were measured by an attending nurse blinded to group allocation, before and after each 30 minute session (pre‐ and post‐surgery).
PAIN: Pain was measured post‐operatively using a VAS. Pain medication ("cumulative opioid consumption") was also recorded, units unclear.
WELLBEING: Measured pre‐ and post‐ each 30 minute session using a VAS with end‐points marked "calm" and "very anxious". For purposes of review this data is considered as the outcome ANXIETY.

Sensitivity analyses conducted using data extracted for pre‐operative and post‐operative scores for anxiety, RR, BP, and HR.

Findings reported in the paper cannot be replicated using the data provided in the table, leading to concerns over either the validity of information provided or selective outcome reporting (due to the multiple ways data could have been analysed). For this reason the study has been removed in sensitivity analyses.

See Cepeda 2006 for details on music for pain relief.

Jacobson 1999

RCT; 3 parallel groups.

DESCRIPTION: 110 in‐patients and out‐patients undergoing IV catheter insertion in Southwestern public and private hospitals, USA.
NUMBERS: (Saline group = 38 patients), Music group = 36 patients, Control group = 36 patients.
AGE, mean (SD): overall = 53 (14) years old.
GENDER (male/female): 58/52
ETHNICITY (Caucasian/Black/Hispanic): 74/25/11.
INCLUSION CRITERIA: 18 years and older, English speaking, vision and hearing in tact, medical orders for peripheral IV therapy.
EXCLUSION CRITERIA: cognitive, neurological, or motor impairment.

SALINE GROUP: excluded from review as confounding non‐environmental intervention.
MUSIC GROUP: choice of 11 compact discs representing different music styles (e.g. jazz, country).
CONTROL GROUP: standard care.

PAIN INTENSITY: measured via 100mm VAS.
PAIN DISTRESS: measured via 100mm VAS.
INSERTION DIFFICULTY: Difficulty of IV catheter insertion via 100mm VAS.
IV catheter insertion difficulty checklist (12 items to identify factors contributing to difficulty).
Patients filled out the pain scores and the investigator rated the insertion difficulty immediately after IV insertion or failed IV insertion attempt.

See Cepeda 2006 for details on music for pain relief.

Insertion difficulty is not included in the present review as a health‐related outcome.

Kliempt 1999

RCT; 3 parallel groups.

DESCRIPTION: 76 in‐patients undergoing surgery with general anaesthetic, in Sidcup, UK.
NUMBERS: Music group = 25, Control group = 26, Binaural beats group = 25.
AGE, mean: Music group = 48.7, Control group = 46.9, Binaural Beats group = 41.8
GENDER (male/female): Music group = 9/16, Control group = 9/17, Binaural beats group = 15/10.
ETHNICITY: not described.
INCLUSION CRITERIA: ASA 1‐2; Aged 18‐76 years old; Scheduled for general surgical operations under general anaesthesia.
EXCLUSION CRITERIA: Disliked classical music; knew the Monroe Institute or knew about Hemi‐Sync (Binaural Beats) music; suffered from known malignancy; hearing impairment; mentally impaired; used regular pain killers, tranquillisers, or antihypertensive medicines; known alcoholic or drug user; history of epilepsy or mental illness; were pregnancy; scheduled for operation involving the head or neck area; were not suitable for the standardised anaesthetic technique.

MUSIC GROUP: Classical music ('Adagio' Karajan, Deutsche Grammophon, 445 282‐4). Played via headphones during surgery.
CONTROL GROUP: Blank tape via headphones during surgery.
BINAURAL BEATS GROUP: Hemispheric sychronisation through binaural beats, played via headphones during surgery. (Not included in review).

FENTANYL REQUIIREMENTS: This served as an indication of the adequacy of nociception control provided during the operation. Fentanyl (ųg) was given intravenously if intra‐operative BP or HR increased by 20% or more above baseline values for more than 5 minutes.

See Cepeda 2006 for details on music for pain relief.

Koch 1998a

RCT; 2 parallel groups.

DESCRIPTION: 34 out‐patients undergoing urologic procedures using spinal anaesthesia, USA.
NUMBERS: Music group = 19, Control group = 15.
AGE, mean (SD): Music group = 54 (15), Control group = 53 (12) years old.
GENDER (male/female): Music group = 16/3; Control group = 13/2.
ETHNICITY: Not described.
INCLUSION CRITERIA: Unpremedicated with ASA status 1‐3.
EXCLUSION CRITERIA: Not stated.

MUSIC GROUP: All patients requested to bring their favourite CD to hospital on morning of surgery. A suitable substitution was provided to those who did not have access to their favourite CD. Music played via occlusive headphones intraoperatively.
CONTROL GROUP: As with music group, patients were asked to bring their favourite CD to the hospital. Patients in the control group did not listen to music nor did they wear headphones. They were exposed to the operating room noise (standard care).

BP (mm Hg), HR (bpm), PROPOFOL REQUIREMENTS (mg/min): recorded every 10 minutes for duration of surgery;
PACU LENGTH OF STAY (min).

See Cepeda 2006 for details on music for pain relief.

Koch 1998b

RCT; 2 parallel groups.

DESCRIPTION: 43 patients undergoing lithotripsy, USA.
NUMBERS: Music group = 21, Control group = 22.
AGE, mean (SD): Music group = 54 (15), Control group = 53 (12) years old.
GENDER (male/female): Music group = 17/4, Control group = 10/12.
ETHNICITY: Not described.
INCLUSION CRITERIA: ASA status 1‐3; scheduled for lithotripsy treatment of renal calculi using the Dornier 3 or 4 lithotripter.
EXCLUSION CRITERIA: None described.

MUSIC GROUP: Patients brought own music from home to listen to via occlusive headphones during surgery.
CONTROL GROUP: Standard care. Also brought in own music in case of allocation to other group.

BP (mm Hg), HR (bpm), ALFENTANIL REQUIREMENTS: recorded every 15 mins.
PAIN SCORE: Self‐report VAS recorded every 15 minutes intraoperatively.

Insufficient information for extraction of: PACU length of stay, desaturation rate, level of sedation, self‐report sedation.

See Cepeda 2006 for details on music for pain relief.

Korunka 1992

RCT; 3 parallel groups.

DESCRIPTION: 163 in‐patients undergoing hysterectomy in Vienna, Austria.
NUMBERS: Music group = 55, Control group = 53.
AGE, mean (SD): Music group = 44.9 (7.6), Control group = 46.8 (8.4) years old.
GENDER: Female = 163 (100%).
ETHNICITY: not described.
INCLUSION CRITERIA: All women scheduled for hysterectomy.
EXCLUSION CRITERIA: Cardiovascular disease; psychological problems; risk of cancer in uterus.

MUSIC GROUP: Patient choice of classical (Bach), Entertainment ("Musik zum Träumen" [Music for Dreaming]), or Relaxation (Oliver Shanti "Rainbow Way"). Played via headphones for 45 minutes beginning at the start of the operation (at the abdominal incision).
POSITIVE SUGGESTIONS: Excluded from review.
CONTROL: Recording of OR noise played via headphones.

PAIN: Pain intensity measured via 10 cm VAS once a day for 5 days. There were no differences between groups.
Post‐operative pain measured via a multidimensional pain scale (with 6 subscales). Significant differences were found between the music and control group (control scores consistently higher than music on all subscales). Data presented in graphs‐ UNCLEAR.
MEDICATION: Time of request and dose of pain medications was recorded. Patients could request up to 4 more doses of medication. Patients in the music group had reduced pain medication compared to controls. Outcomes missing for 23 participants (unclear which groups):
Time to first medication administration, mean (SD):
Music = 211 (240), Control = 118 (154) minutes.
Overall pain medication dose, mean (SD):
Music = 197 (138), Control = 291 (175) uG/K.
Length of stay, mean (SD):
Music = 8.52 (2.0), Control = 10.20 (3.8) days.

Where means and SDs are presented (for length of stay), there are missing data from 23 participants so it is unclear how many people are in each group.

See Cepeda 2006 for details on music for pain relief.

Kotwal 1998

RCT; 2 parallel groups.

DESCRIPTION: 104 patients undergoing gastrointestinal endoscopy in India.
NUMBERS: Music group = 54, Control group = 50 patients.
AGE: not described.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: Classical Indian instrumental music played for 10 minutes prior to procedure and then throughout the procedure.
CONTROL GROUP: no music, standard care.

PHYSIOLOGICAL OUTCOMES: BP, HR, and RR measured at beginning of the consultation and at the end of the procedure. Methods unclear. Data presented as change scores.
ATTITUDE: a 3‐point VRS was used to assess willingness to undergo procedure again‐ data not extracted for review.

Kwekkeboom 2003

RCT; 3 parallel groups.

DESCRIPTION: 58 patients undergoing noxious medical procedures (e.g. tissue biopsy, vascular port placement) at an oncology clinic in Midwestern USA.
NUMBERS: Music group = 24, Control group = 20, Distraction group = 14 (excluded from review).
AGE, mean (SD): Music group = 51.96 (15.21), Control group = 53.30 (17.83) years old.
GENDER, (male/female): Music group = 9/15, Control group = 7/13.
ETHNICITY (white/other): Music group = 21/3, Control group = 20/0.
INCLUSION CRITERIA: Treated by one particular surgeon.
EXCLUSION CRITERIA: Unable to read/write English; incapable of completing questionnaires independently or with minor assistance from researcher.

MUSIC GROUP: Patient choice from selection of CDs (pop, rock, easy listening, classical, religious hymns, jazz or blues, country), listened via headphones prior to and during procedure.
CONTROL GROUP: Standard care. Asked to rest quietly prior to and during procedure.
DISTRACTION GROUP: Excluded from review. Book on tape with quiz post‐treatment.

PAIN: Pain intensity measured via a NRS prior to treatment, during treatment (retrospectively), and post treatment.
ANXIETY: State anxiety measured via STAI pre‐ and post‐procedure.
CONTROL: Perceived control over pain and anxiety was measured via a NRS post‐procedure. Data not extracted for review (compound question not validated).

Values provided are adjusted scores (from analysis of covariance), adjusted for baseline scores, medications, and gender. Numbers reported as SDs in the text although too small so assumed to be the standard errors, which reflect the non‐significant findings described.

See Cepeda 2006 for details on music for pain relief

Lee 2002

RCT; 3 parallel groups.

DESCRIPTION: 165 out‐patients undergoing elective colonoscopy in Hong Kong, China.
NUMBERS: 55 patients per group.
AGE, median (interquartile range): Music + PCS = 54 (46‐68); PCS alone = 47 (39‐67).
GENDER (Male/Female): Music + PCS = 33/22; PCS alone = 29/26.
ETHNICITY: not specified.
INCLUSION CRITERIA: Scheduled for elective out‐patient colonoscopy, 16‐75 years old.
EXCLUSION CRITERIA: none stated.

MUSIC ALONE: excluded from review as no appropriate control (i.e. music with no PCS).
MUSIC + PCS: music played via headphones, patients offered a choice of classical, jazz, popular (Chinese or English), and Chinese opera. Patient controlled sedation administered via pump.
PCS ALONE: patient controlled sedation via pump with no music or headphones.

PAIN SCORE: 10 mm VAS;
SATISFACTION: 10 mm VAS;
WILLINGNESS TO REPEAT SEDATION: (not included as health‐related outcome in review);
PAIN MEDICATION: Dose of propofol (mg/kg) ‐ patient‐controlled sedation.
EPISODES OF HYPERTENSION: systolic BP < 90 mm Hg, observed by blinded assessor (4 vs. 6 episodes in 'music + PCS' and 'PCS alone' groups respectively‐ unclear if numbers are independent).
EPISODES OF OXYGEN DESATURATION: Oxygen saturation < 90%, observed by blinded assessor (no events observed).
RECOVERY TIME: Assessed every 5 minutes by independent (blinded) recovery nurse until patient was orientated to person, time, and place, and able to serially subtract 7 from 100. Results presented as median and interquartile range.

See Cepeda 2006 for details on music for pain relief.

Lee 2005

RCT; 2 parallel groups.

DESCRIPTION: 64 in‐patients on mechanical ventilation in an Intensive Care Unit in Hong Kong, China.
NUMBERS: 32 patients per group.
AGE, mean (SD): Music group = 70.6 (15.1); Control group = 68.3 (15.6).
GENDER (Male/Female): Music group = 25/7; Control = 21/11.
ETHNICITY: not stated.
INCLUSION CRITERIA: alert, able to obey commands, able to hear, haemodynamic stability, undergoing mechanical ventilation with self‐triggering modes.
EXCLUSION CRITERIA: psychiatric illness.

MUSIC GROUP: Choice of Chinese classical music, religious music (Buddhist and Christian), Western classical, natural sounds with slow beats. Played via headphones.
CONTROL GROUP: Headphones without music.
All patients instructed to close eyes. The lights were dimmed and the curtains were closed for all patients. Intervention and control periods lasted for 30 minutes.

ANXIETY: State anxiety using Chinese STAI ‐short version (6 items). Participants responded to questions by holding up corresponding number of fingers.
RR;
HR;
BP;
All measure taken before and after 30 minute intervention/control period.

Lembo 1998

RCT; 3 parallel groups.

DESCRIPTION: 37 patients undergoing flexible sigmoidoscopy in Calfornia, USA.
NUMBERS: Audiovisual group = 13, audio alone group = 12, control group = 12.
AGE, mean (SD): Audiovisual group = 58 (7), Audio alone group = 60 (8), Control group = 59 (7) years old.
GENDER: Male = 37 (100%).
ETHNICITY: not described.
INCLUSION CRITERIA: Undergoing routine screening flexible sigmoidoscopy.
EXCLUSION CRITERIA: none described.

AUDIOVISUAL: Virtual‐i glasses, personal display system showing an ocean shoreline with corresponding sounds (via headphones)
AUDIO ALONE: Sounds of the ocean shoreline only played via headphones.
CONTROL: No intervention, standard care.

DISCOMFORT: Measured via VAS which asked patients to rate their level of abdominal discomfort from faint to severely intense.
STRESS SYMPTOMS: Measured 6 subscales (arousal, stress, anxiety, anger, fatigue, and attention) using 12 VAS.

Data extracted for review on anxiety and anger. Arousal and attention not considered health‐related outcomes.

There was no difference between groups on the stress and fatigue subscales, data not reported for extraction.

Lepage 2001

RCT; 2 parallel groups.

DESCRIPTION: 50 in‐patients and out‐patients undergoing non‐oncologic surgery under spinal anaesthesia in Canada.
NUMBERS: 25 patients per group.
AGE, mean (SD): Music group = 37.8 (12.6), Control group = 38.9 (8.6) years old.
GENDER (male/female): Music group = 15/10, Control group = 16/9.
ETHNICITY: not described.
INCLUSION CRITERIA: ASA I or II; scheduled to undergo non‐oncologic surgery under spinal anaesthesia.
EXCLUSION CRITERIA: Parturients; patients experiencing mental illness; documented hearing loss; taking drugs likely to influence mood or haemodynamic status.

MUSIC GROUP: Choice of pop, jazz, classical, and new age played via non‐occlusive headset. Patients received the music prior to, during and after surgery.
CONTROL GROUP: standard care (no music).

PCS: Amount of midazolam consumed during the perioperative period was recorded. Data extracted for total midazolam consumed (mg).
ANXIETY: Measured via STAI and VAS at four time points. Data presented in graph form and estimated readings of end scores taken from this.
PHYSIOLOGICAL DATA: BP, HR, and RR collected in study although data not presented for extraction. There were no significant differences between groups on any of these measures.

Estimated anxiety data extracted.

Physiological data not presented: n.s.

Lueders Bolwerk 1990

RCT; 2 parallel groups.

DESCRIPTION: 35 in‐patients in one of 5 Intensive Care Units having had an acute myocardial infarction, Midwestern USA.
NUMBERS: Music group = 17 patients, Control group = 18 patients.
AGE, mean (range): Music group = 61 (36‐79), Control group = 56.3 (33 to 78).
GENDER (male/female): Music group = 11/6, Control group = 16/2.
ETHNICITY: not described.
INCLUSION CRITERIA: Anxious patients (STAI state anxiety score ≥ 40), medical diagnosis of MI, within 48 hours of hospitalisation, patients understood they had had a "heart attack".
EXCLUSION CRITERIA: Class 4 MI patient (physiologically unstable).

MUSIC GROUP: 3 sessions of music listening on 1st, 2nd, and 3rd day (or 2nd‐4th day) of hospitalisation. Music session consisted of listening to 3 pieces of music each session: Bach's 'Largo', Beethoven's 'Largo', and Dubussy's 'Prelude to the Afternoon Faun'. Each session lasted approximately 22 minutes.
CONTROL GROUP: standard care, received no music sessions.

STATE ANXIETY: measured with the STAI at two time points: (1) during the first 48 hours of admission, and (2) on the 3rd or 4th day of hospitalisation. For the music group, these measurements were taken prior to the first music session and at the end of the 3rd music session.

Mandle 1990

RCT; 3 parallel groups.

DESCRIPTION: 45 patients undergoing femoral angiography in Boston, USA.
NUMBERS: Music group = 14 patients, Control group = 16 patients, Relaxation tape group = 15 patients (excluded from review).
AGE: not described.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: Peripheral vascular disease undergoing femoral angiography.
EXCLUSION CRITERIA: not described.

RELAXATION TAPE: Progressive muscle relaxation. Excluded from review.
MUSIC TAPE: Contemporary instrumental music ("Music for Airports" by Brian Eno, EG Music, New York, 1978).
CONTROL GROUP: Blank tape.

Participants instructed to listen to the tape throughout the entire procedure.

STATE ANXIETY: Measured via STAI immediately pre‐ and post‐procedure.
PAIN: Measured using the pain rating index and the pain intensity scale of the McGill Pain Questionnaire. Pain intensity data extracted for review.
NURSE RATINGS: Nurses rated the degree of pain and anxiety exhibited by each patient during the procedure on a 7‐point scale. Data not included in review.
MEDICATION REQUESTS: A record of kept of the amount of Fentanyl Citrate (ųg) and Diazepam consumed.
VITAL SIGNS: BP and HR were measured however no data presented. No significant differences reported.

See Cepeda 2006 for details on music for pain relief.

Masuda 2005

RCT; 2 parallel groups.

DESCRIPTION: 44 post‐operative in‐patients in an Orthopaedic Department, Japan.
NUMBERS: 22 patients per group.
AGE, mean (SD): Music group = 67.1 (4.8), Control group = 70.8 (7.7) years old.
GENDER (male/female): Music group = 9/13, Control group = 9/13.
ETHNICITY: not described.
INCLUSION CRITERIA: Over 60 years old; undergone surgical treatment of any kind, with general or spinal anaesthesia, in the Orthopaedic Department between April 2001 and November 2002; were required to be on post‐operative bed rest for one week or less in a private room.
EXCLUSION CRITERIA: cardiovascular disease; hypertension; mental illness.

MUSIC GROUP: Choice of: Western classical music, Gagaku (Japanese traditional court music), Noh songs, or Enka. All participants choose Enka (a melodramatic and representative genre of Japanese popular songs, usually about sad aspects of life, irrecoverable destiny, and desertion by a lover, sung with a slow tempo), which is popular among elderly Japanese people. There were 10 Enka CDs to choose from. Music played via headphones for 20 minutes whilst lying in bed.
CONTROL GROUP: No headphones or music.

PAIN: Measured via 10 cm VAS and the Wong/Baker Faces Pain Rating Scale (includes 6 categories of facial expressions ranging from '0, a happy smiling face' and '5, a tearful face').
VITAL SIGNS: HR and BP measured via an automatic sphygmomanometer.
SKIN TEMPERATURE: Taken at the palmar centre point of the tip of the middle finger with a thermograph. Room temperature was adjusted with an air conditioner and monitored thermographically. Skin and room temperature had to be stable for 5 minutes before beginning the experiment. Patients kept their hands on top of the bed quilts.
SKIN BLOOD FLOW: measured using a laser type skin blood flow analysis system (FLO‐C1, Omega Wave Co., Ltd.) with a skin contact probe taped the palmar centre point of the tip of the index finger. This device measures blood flow, blood mass, and blood velocity.

Outcome measures recorded at baseline, and at 10 and 20 minutes.

See Cepeda 2006 for details on music for pain relief (study not yet included in Cepeda 2006).

McRee 2003

RCT; 4 parallel groups.

DESCRIPTION: 52 in‐patients undergoing various surgical procedures in USA.
NUMBERS: 13 patients in each group.
AGE, mean (SD): 43.08 (13.1) years old.
GENDER (male/female): 19/33.
ETHNICITY: not described.
INCLUSION CRITERIA: At least 18 years old; Read English; Low‐risk surgical patients (determined by pre‐operative assessment by anaesthesia provider on the ASA scale).
EXCLUSION CRITERIA: Not described.

Demographic information detailed includes information from study groups excluded from this review. Demographic characteristics were similar between groups.

MASSAGE THERAPY: excluded from review.
MASSAGE AND MUSIC: excluded from review.
MUSIC ONLY GROUP: compilation of soft piano music selected by investigator. played for 30 minutes pre‐operatively.
CONTROL GROUP: Standard care, waited in the waiting room.

STATE ANXIETY: measured via the short‐form STAI‐6 in the PACU (after surgical procedure).
VITAL SIGNS: BP and pulse (measured pre‐operatively, intraoperatively, and post‐operatively) measured using automatic monitoring equipment. End time‐points extracted for analysis.
HORMONES: Established post‐operatively. Cortisol measured by a chemiluminescent immunoassay, and prolactin measured with a two‐site sandwich antibody assay.
Blood was sent to a regional laboratory for processing.
PAIN CONTROL: amount and frequency of analgesia administered, was measured in the recovery room. Data not presented although states no significant differences.

See Cepeda 2006 for details on music for pain relief (study not included in Cepeda 2006).

Mennegazzi 1991

RCT; 2 parallel groups.

DESCRIPTION: 38 emergency department admissions undergoing laceration repair in Pittsburgh, USA.
NUMBERS: 19 patients per group.
AGE, mean (SD): Music group = 24.4 (5.1), Control group = 25.9 (7.5) years old.
GENDER (male/female): Music group = 13/6, Control group = 8/11.
ETHNICITY: not described.
INCLUSION CRITERIA: All patients presenting to the emergency department for laceration repair.
EXCLUSION CRITERIA: Laceration repair secondary to more serious medical condition; under 18 years old; received analgesics in the field; alcohol or substance intoxication.

MUSIC GROUP: Listened to music via headset. Choice of 50 styles and artists to choose from.
CONTROL GROUP: Standard care.

ANXIETY: State anxiety measured via STAI before and after laceration repair. SDs presented in graphical format. Estimated figures extracted for purposes of review.
PAIN: Measured via VAS after laceration repair. Estimated SDs extracted from graph.
PHYSIOLOGICAL: HR, BP, RR data collected before and after laceration repair by nurses although methods of data collection unclear.

SDs for pain and anxiety are estimates from graphs.

See Cepeda 2006 for details on music for pain relief.

Migneault 2004

RCT; 2 parallel groups.

DESCRIPTION: 30 patients undergoing surgery with general anaesthesia, Canada.
NUMBERS: 15 patients per group.
AGE, mean (SD): Music group = 46.3 (12.1), Control group = 52.2 (9.1) years old.
GENDER: All female.
ETHNICITY: Not described.
INCLUSION CRITERIA: ASA grade I‐III, 18‐70 years old, scheduled for abdominal hysterectomy, hysterosalpingo‐oophorectomy, or salpingo‐oophorectomy under general anaesthesia.
EXCLUSION CRITERIA: Auditory problems, uncontrolled hypertension, Raynaud syndrome, hormonal dysfunction (adrenal, pituitary, or thyroid), steroid use, cocaine abuse, established diagnosis of severe anxiety disorder.

MUSIC GROUP: Selected a CD preoperatively from a choice of 4: classical, jazz, new‐age, popular piano music. Selected listening volume. Anesthesiologist started CD once patients were anaesthetised. Music played via headphones.
CONTROL GROUP: Also selected music prior to surgery. Wore headphones during surgery however no music was played.

The CD player was covered in both groups to blind the investigator. At the end of wound closure and after the last intraoperative blood sample was drawn, the CD was stopped and the headphones removed.

Repeated measures observations (4 time points)‐ T1: immediately after arterial line insertion, T2: 5 min after peritoneal incision, T3: at skin closer, T4: 30 min after arrival in the recovery area.
STRESS HORMONES: Epinephrine, norepinephrine, cortisol and adrenocorticotropic hormone.
PHYSIOLOGICAL OBSERVATIONS: Arterial BP; and HR.
MORPHINE: Total administered via PCA for the first 24 post‐operative hours (mg).

ADVERSE EVENTS: Six patients in the music group versus two patients in the control group needed rescue medication for hypertensive episodes (P value = 0.13).

Data extracted for end time points only.

See Cepeda 2006 for details on music for pain relief

Mullooly 1998

RCT; 2 parallel groups.

DESCRIPTION: 28 post‐operative in‐patients who have undergone elective abdominal hysterectomy, USA.
NUMBERS: 14 patients in each group.
AGE, mean (range): 47 (37 to 57) years old.
GENDER: Female = 28 (100%).
ETHNICITY (White/other): 25/3
INCLUSION CRITERIA: undergoing elective abdominal hysterectomy.
EXCLUSION CRITERIA: History of drug abuse; psychiatric disorder; potential malignant neoplasm; experience with use of relaxation techniques.

MUSIC GROUP: Four easy listening selections (out of an original 10) were selected by nursing graduate students to be harmonious, pleasant, and calming. Patients listened to music for 10 minutes via headphones and were requested to close eyes on the first and second post‐operative day.
CONTROL GROUP: Standard care.

PAIN: measured via VAS on first and second post‐operative day (pre and post 10 minute intervention period).

ANXIETY: measured via a NRS (with VRS) pre‐ and post‐intervention period on first and second day.

Outcomes extracted for 2nd post‐operative day as only 6 and 5 outcome measures were obtained for the intervention and control group on the 1st post‐operative day (all 28 participants completed the 2nd day of testing).

See Cepeda 2006 for details on music for pain relief.

Nilsson 2001

RCT; 3 parallel groups.

DESCRIPTION: 90 (58 included in present review) in‐patients undergoing elective hysterectomy in Sweden.
NUMBERS: Music group = 30, Control group = 28 patients.
AGE, mean (SD): Music group = 51 (8.1), Control group = 50 (8.2) years old.
GENDER: Female = 90 (100%), (58 included in review).
ETHNICITY: not described.
INCLUSION CRITERIA: ASA I‐III, scheduled for elective abdominal hysterectomy via lower abdominal incision, good understanding of Swedish.
EXCLUSION CRITERIA: Hearing impairment, alcohol or drug abuse, psychiatric or memory disorder.

MUSIC GROUP: relaxing music accompanied by sea waves (ref: Uneståhl L‐E. Avslappningmusik. Träningsprogram för kropp och själ. [Relaxation music. Training programme for body and soul]. Örebro, Sweden Veje International AB: 1970). Played through headphones from time of skin incision to time of wound closure.
MUSIC +THERAPEUTIC SUGGESTIONS: Excluded from review.
CONTROL: playback of previously recorded operation. Played through headphones from time of incision to time of wound closure.

PAIN INTENSITY: 10‐point VAS used every hour for the first 24 post‐operative hours, and every 3 hours after that until the patient felt no pain. Data presented as group mean score of patients' median score.
POST‐OPERATIVE ANALGESIA: This was recorded from the amount of patient controlled analgesia used.
MOBILISATION: Estimated as time from the end of surgery to the time the patient could sit, stand, and walk without assistance. Recorded by the patient in a patient diary.
POST‐OPERATIVE FATIGUE, WELLBEING, AND NAUSEA: Graded on individual VRS by the patient in a diary on the day of surgery, the day after surgery and at discharge from the hospital.

Data extracted for responses given on the day of surgery.

See Cepeda 2006 for details on music for pain relief.

Nilsson 2003a

RCT; 3 parallel groups.

DESCRIPTION: 151 day patients undergoing surgery of varicose veins or inguinal hernia repair under general anaesthesia, in Sweden.
NUMBERS: Intra‐operative music = 51, Post‐operative music = 51, Control = 49 patients.
AGE, mean (SD): Intra‐operative music = 54 (14.5), Post‐operative music = 53 (14.7), Control = 54 (12.2) years.
GENDER (male/female): Intra‐operative music = 39/12, Post‐operative music = 35/16, Control = 33/16.
ETHNICITY: not described.
INCLUSION CRITERIA: Good understanding of Swedish, ASA I‐II, 21 to 85 years old, scheduled for day‐case surgery of varicose veins or inguinal hernia repair under general anaesthesia.
EXCLUSION CRITERIA: Hearing impairment, drug abuse, psychiatric or memory disorder.

INTRA‐OPERATIVE MUSIC GROUP: Music played via headphones from end of induction of anaesthesia until wound dressing via headphones. Music was soft instrumental comprising 7 melodies of a new‐age synthesizer. Post‐operatively, in the PACU, patients were exposed for 1 hour to a blank (silent) disc via headphones.
POST‐OPERATIVE MUSIC GROUP: Exposed to blank disc intra‐operatively via headphones, and the same music as above for 1 hour post‐operatively in the PACU, via headphones.
CONTROL GROUP: Blank disc both intra‐operatively and post‐operatively.

PAIN INTENSITY: Post‐operatively on a NRS (0 to10), every 30 minutes for 2 hours in the PACU.
MORPHINE REQUIREMENTS: Total amount of post‐operative morphine requirements in the PACU recorded from patient records (mg).
ANXIETY: Recorded pre‐operatively, after 1hour in the PACU, at discharge, at home in the evening of the day of surgery, days 1 and 2 following surgery in the morning and evening, on a NRS (0 to 10).
FATIGUE: Using a NRS (0 to10), recorded after 1 hour in the PACU, at discharge, at home in the evening of the day of surgery, days 1 and 2 after surgery in the evening.
NAUSEA: Using a NRS (0 to10), recorded after 1 hour in the PACU, at discharge, at home in the evening of the day of surgery, days 1 and 2 after surgery in the morning and evening.
NIGHT SLEEP: Recorded in the morning on the 1st and 2nd day after surgery on a NRS.
SATISFACTION: patient NRS rating (0 to10) of peri‐operative care.

Anxiety and fatigue not presented in enough detail. Findings on night sleep not reported at all.

See Cepeda 2006 for details on music for pain relief.

Nilsson 2003b

RCT; 3 parallel groups.

DESCRIPTION: 182 (125 included in present review) day patients undergoing surgery for varicose veins or inguinal hernia repair under general anaesthesia, from two hospitals in Sweden.
NUMBERS: Music group = 62, Control group = 63 patients.
AGE, mean (SD): Music group = 53 (14.1), Control group = 52 (13.2) years old.
GENDER (male/female): Music group = 44/18, Control group = 48/15.
ETHNICITY: not described.
INCLUSION CRITERIA: Good understanding of Swedish, ASA I‐II, scheduled for day care surgery of varicose veins or open inguinal hernia repair under general anaesthesia.
EXCLUSION CRITERIA: Hearing impairment, drug abuse, known psychiatric or memory disorder.

MUSIC GROUP: Soft classical music via headphones which allow conversation to take place. Played on auto‐reverse from the time of arrival at the PACU until the patient wanted to stop listening.
CONTROL GROUP: Blank tape (silence). Played from time of arrival at the PACU until the patient wanted to stop listening.
MUSIC + THERAPEUTIC SUGGESTIONS: excluded from review due to psychological intervention.

PAIN INTENSITY: taken every 30 minutes until patient reports a pain level of ≤ 3 on a VAS (0 to 10). Data presented as the mean of median scores in 120 minutes.
MORPHINE REQUIREMENT (mg): taken from the patient records.
ANXIETY: recorded using the STAI, pre‐operatively at the hospital, and post‐operatively at home on the day of the surgery.
SYMPTOMS: well‐being, nausea, headache, fatigue, and urinary problems recorded using VRSs post‐operatively at home in the evening of the day of the surgery.

There was a significant difference in the length of time patients listened to their allocated tape.
Music group = 117.0 (50.6) minutes
Blank tape group = 80.2 (44.9) minutes.

See Cepeda 2006 for details on music for pain relief.

Nilsson 2005

RCT; 3 parallel groups.

DESCRIPTION: 75 day patients undergoing surgery of open Lichtenstein inguinal hernia repair, in Sweden.
NUMBERS: 25 patients in each group.
AGE, mean (SD): Intra‐operative music = 55 (14.7), Post‐operative music = 56 (16.8), Control = 57 (11.6) years.
GENDER: 24 males per group, 1 female per group.
ETHNICITY: not described.
INCLUSION CRITERIA: ASA grade I‐II, scheduled for day care surgery between 8 and 11.30am of open Lichtenstein inguinal hernia repair under general anaesthesia.
EXCLUSION CRITERIA: Hearing impairment, diabetes mellitus, treatment with corticosteroids.

INTRA‐OPERATIVE MUSIC GROUP: exposed to new‐age synthesizer music during operation, and a sham (silent) CD for 1 hour post‐operatively in the PACU.
POST‐OPERATIVE MUSIC GROUP: exposed to sham (silent) CD intra‐operatively, and new‐age synthesizer music for 1 hour post‐operatively in PACU.
CONTROL GROUP: Exposed to sham (silent) CD both intra‐operatively and for 1 hour post‐operatively.

All patients wore headphones throughout. Intra‐operative headphones were occlusive to block out other sounds; post‐operative headphones allowed conversation between patients and staff. Intra‐operative period ran from end of anaesthesia induction to after wound dressing at the end of the surgery.

PAIN: assessed by NRS (0 to 10), 30 minutes before anaesthesia and 1 hour after admission to PACU.
ANXIETY: same as pain score.
BP, HR, and OXYGEN SATURATION: assessed at same time points as pain, using a digital BP monitor and pulse oximetry.
MORPHINE REQUIREMENTS: total amount used in the PACU was recorded (mg).
SERUM CORTISOL, BLOOD GLUCOSE LEVELS, and SERUM IgA LEVELS: taken at 5 time points: 30 minutes prior to anaesthesia, at the end of surgery after wound dressing, and at the 1st, 2nd, and 3rd hour after arrival at the PACU. Not enough data presented for extraction.

Data extracted for post‐operative music group versus control group.

See Cepeda 2006 for details on music for pain relief (study not yet included in Cepeda 2006).

Nowobilski 2005

RCT; 2 parallel groups.

DESCRIPTION: 36 in‐patients with bronchial asthma, in Poland.
NUMBERS: 18 patients per group.
AGE, mean (SD): Music group = 44.9 (15.9), Control group = 47.4 (13.4) years old.
GENDER (male/female): 13/23.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: Underwent 10 day rehabilitation programme, including 45 minutes each day of: exercise of breath control, correction of respiratory pattern, training of diaphragm and additional respiratory muscles, plus an additional 15 minutes of music listening (C.M. Weber "Adagio"; J.S. Bach "Air on a G‐string"; V.A. Mozart "Andante z Divertimenta D‐dur").
CONTROL GROUP: Underwent 10 day rehabilitation programme, including 45 minutes each day of: exercise of breath control, correction of respiratory pattern, training of diaphragm and additional respiratory muscles. Did not receive additional music listening.

ANXIETY: Measured via the STAI at baseline and after the 10th session.
There was no significant difference between groups:
F (1,34) = 0.37, P value = 0.55

DYSPNEA: Measured via the Borg dyspnoea scale at baseline and after the 10th session.
There was no significant difference between groups:
F (1, 32) = 1.02, P value = 0.32

Data not provided in sufficient detail for extraction.

Padmanabhan 2005

RCT; 3 parallel groups.

DESCRIPTION: 104 day‐patients scheduled for elective surgical procedures (gynaecology, general surgery, urology) in a Day Surgery Unit in England.
NUMBERS: Music + binaural beat = 35 patients, Music only = 34 patients, Control = 35 patients.
AGE: not described.
GENDER (male/female): Music+binaural beat = 12/23, Music only = 12/22, Control = 15/20.
ETHNICITY: not described.
INCLUSION CRITERIA: Scheduled to undergo elective surgery with general anaesthetic.
EXCLUSION CRITERIA: History of epilepsy, < 16 years old, history of profound deafness.

MUSIC + BINAURAL BEAT: taken to a quiet environment pre‐operatively and asked to listen to music with their eyes closed; 30 minute soundtrack (Holosync Solution, 'Awakening Prologue', Centerpointe Research Institute, Beaverton, OR) which produces binaural beats (through two similar pure tones being presented separately to each other).
MUSIC ONLY: taken to a quiet environment pre‐operatively and asked to listen to music with eyes closed; Identical soundtrack to above without the added tones.
CONTROL: standard care, allowed to read or watch television for 30 minutes pre‐operatively.

STATE ANXIETY: measured via the STAI before and after intervention period. Results converted to percentages instead of presenting STAI score.

It is unclear if > 90% of participants are 18 years old or over.

Data extracted for music only group versus control group.

Confidence intervals have been used to estimate standard deviations for purposes of review.

Palakanis 1994

RCT; 2 parallel groups.

DESCRIPTION: 50 out‐patients undergoing flexible sigmoidoscopy in Maryland, USA.
NUMBERS: 25 patients per group.
AGE, mean (range): Music group = 55 (22 to 76), Control group = 49 (20 to 79).
GENDER (male/female): Music group = 17/8, Control group = 20/5.
ETHNICITY: not described.
INCLUSION CRITERIA: scheduled for out‐patient flexible sigmoidoscopy. No patients were taking anxiolytic medications.
EXCLUSION CRITERIA: none described.

MUSIC GROUP: Choice of 20 tapes (classical/country‐western/popular/rhythm and blues/gospel) played via headphones throughout the procedure.
CONTROL GROUP: Standard care.

ANXIETY: Measured via STAI. An analysis of variance identified a significant difference between groups (P < 0.002):
Music group = 25.24
Control group = 31.48
PHYSIOLOGICAL: BP and HR measured via Dinamap Model 845XT before and during the procedure (at full insertion of the sigmoidoscope). Paper reports significantly less change in HR and mean arterial BP for the music group.
Mean HR:
Music group: Before = 86 bpm; During = 84 bpm
Control group: Before = 75 bpm; During = 80 bpm
Mean arterial BP:
Music group: Before = 111; During = 110 mm Hg
Control group: Before = 104; During = 115 mm Hg

No SDs reported. Insufficient data for extraction.

Phumdoung 2003

RCT; 2 parallel groups.

DESCRIPTION: 110 in‐patients giving birth for the first time (to a singleton fetus), in Southern Thailand.
NUMBERS: 55 in each group.
AGE (mean, SD): 24 (3) years old.
GENDER: Female = 110 (100%).
ETHNICITY: not described.
INCLUSION CRITERIA: Married primiparas, 20 to 30 years old, with a singleton fetus, received antenatal care from the 2nd trimester, been in the latent phase of labour for no more than 10 hours, normal fetal heart rate, cephalic presentation, vertical lie, 38 to 42 weeks gestation with estimated fetal weight of 2500 to 4000 grams.
EXCLUSION CRITERIA: Received analgesic medication, difficulty hearing the spoken word, induced labour, infections, HIV, asthma, previous negative reaction to music, had a spontaneous membrane rupture for longer than 20 hours, history of psychiatric problems, major antipsychotic medications.

MUSIC: patient choice of western music without lyrics, including synthesizer, harp, piano, orchestra, and jazz (60‐80 bpm). Patients listened to their choice via headphones for the first 3 hours of the active phase of labour, starting when cervical dilation was 3 or 4 cm with uterine contraction of 30 to 60 seconds. Women could stop listening to music for 10 minutes if they wished.
CONTROL: No music or headphones, but were told that they would receive music at a later time during labour, after all the pain measurements had been taken.

PAIN SENSATION: measured using 100 mm VAS at four time points‐ once at the start of the study before the treatment period, and then every hour for 3 hours.
PAIN DISTRESS: measured in the same manner as pain sensation.

There was a small ceiling effect reported in the second hour for 4% of controls, and in the 3rd hour for 7% of controls and 5% of the music group.

See Cepeda 2006 for details on music for pain relief.

Schiemann 2002

RCT; 2 parallel groups.

DESCRIPTION: 119 patients undergoing diagnostic endoscopy in Germany.
NUMBERS: Music group = 59, Control group = 60
AGE, mean (SD): Music group = 52.3 (13.9), Control group = 55.8 (13.5) years old.
GENDER (male/female): Music group = 25/34, Control group = 33/27.
ETHNICITY: not described.
INCLUSION CRITERIA: 18 to 80 years old.
EXCLUSION CRITERIA: History of partial colectomy, gastrectomy, or hysterectomy; Impassable colonic stenosis due to a tumour, chronic inflammatory bowel disease, or diverticulitis.

MUSIC GROUP: Played Radio Arabella (105.2 MHz) throughout the procedure. This is a well‐known regional broadcasting company in Munich, and plays various trends of pop, rock, soul, and 'Deutsche Schlager' music, specialising in 'oldies'.
CONTROL GROUP: Standard care.

SEDATION & ANALGESIA: Number of patients requiring midazolam and pethidine, and amount administered. It is unclear from the report if sedation is an outcome measure or baseline characteristic.
TIME: Examination time and number of colonoscopies prematurely aborted due to pain were recorded.
OXYGEN: Number of patients requiring oxygen supplementation was recorded.

See Cepeda 2006 for details on music for pain relief.

Schneider 2001

RCT; 2 parallel groups.

DESCRIPTION: 30 patients undergoing cerebral angiography in Hannover, Germany.
NUMBERS: 15 patients per group.
AGE, mean (range): Music group = 42.1 (26‐58), Control group = 44.3 (25 to 59) years old.
GENDER (male/female): 14/16.
ETHNICITY: not described.
INCLUSION CRITERIA: Undergoing cerebral angiography for the first time.
EXCLUSION CRITERIA: hypertension; cardiac dysrhythmia; anaemia; endocrine disease; psychiatric problems; infections; use of sedative, anxiolytic, or illegal drugs.

MUSIC GROUP: Choice of nine tapes (international pop, German pop, oldies, meditation, rock, techno, instrumental, classic, and traditional). Played via stereo speakers throughout the angiogram; patients could adjust the volume.
CONTROL GROUP: No music (standard care).

ANXIETY: Measured via STAI the evening before the angiography and during the angiography.
ENDOCRINE: Cortisol and catecholamines were taken through an indwelling IV catheter four times: 1) before placing patient on the angiographic table, 2) before giving local anaesthetic, 3) after the first angiographic run, and 4) before returning to bed.
PHYSIOLOGICAL: BP and HR were measured continuously every 5 minutes by a non‐invasive system.

Data not sufficient for extraction.

There were no significant differences between groups in anxiety or HR.

BP decreased significantly in music group but remained constant in the control group.

The control group had a significant increase in cortisol over the angiogram. Cortisol remained constant in the music group.

There were no differences between groups in adrenaline and noradrenaline levels.

Sendelbach 2006

RCT; 2 parallel groups.

DESCRIPTION: 86 post‐operative in‐patients who have undergone cardiac surgery, in cardiovascular units, Midwest USA.
NUMBERS: Music group = 50, Control group = 36
AGE, mean (SD): Music group = 62.3 (14.8), Control group = 64.7 (11.4).
GENDER (male/female): music group = 31/19, Control group = 29/7.
ETHNICITY: not described.
INCLUSION CRITERIA: Scheduled for non‐emergent coronary artery bypass and/or valve replacement surgeries.
EXCLUSION CRITERIA: Non‐English speaking; intubated; physician‐documented psychiatric disorder.

MUSIC GROUP: Participants advised to clear minds and allow muscles to relax. They were given a choice of easy listening, classical, or jazz music, played via headphones, for 20 minutes whilst participant remained in bed. Music qualities were: no dramatic changes, consonance, instrumental, 60 to 70 bpm. The environment was made conducive to rest.
CONTROL GROUP: 20 minute rest period. Advised to rest in bed and a comfortable position was encouraged. No relaxation suggestions were given.

Interventions were for 20 minutes, two times a day, in the morning and evening, of the post‐operative days 1 to 3.

HR: Recorded on bedside monitor. No differences between groups.
BP: Recorded on bedside monitor or with BP cuff. No differences between groups.
ANXIETY: Recorded with short form state anxiety scale. Significantly lower in the music group.
PAIN: Recorded on an NRS. Significantly lower in the music group.
OPIOD REQUIREMENT: No differences between groups.

Paper only reports data for the first 3 sessions due to missing data. SDs obtained from authors (unpublished). Data extracted for morning session of the first post‐operative day.

See Cepeda 2006 for details on music for pain relief (study not yet included in Cepeda 2006).

Smith 2001

RCT; 2 parallel groups.

DESCRIPTION: 42 male out‐patients undergoing radiation therapy in a Veterans Affairs Hospital in Southeastern USA.
NUMBERS: Music group = 19 patients, Control group = 23 patients
AGE: mean (range): Music group = 62.2 (39‐78), Control group = 63.4 (44 to 80).
GENDER: Not described.
ETHNICITY: Caucasian/African‐American/Hispanic/Other: Music group = 11/4/4/0, Control group = 20/1/1/1.
INCLUSION CRITERIA: Expected to receive at least 5 weeks of radiation therapy; 18 years or older; Able to read and understand English.
EXCLUSION CRITERIA: Hearing impaired; overtly psychotic; previous diagnosis of anxiety or currently taking anxiolytic medications; participating in a radiation therapy setup that precludes the use of headphones.

MUSIC GROUP: Patient choice of rock and roll, big band, country and western, classical, easy listening, Spanish, religious. Four to six tapes were available in each category. Each patient could choose one category for the duration of the study. Patients listened via headphones to the music before and during the radiation simulation appointment, and during daily radiation treatments for the duration of course of therapy.
CONTROL GROUP: Standard care.

STATE ANXIETY: measured using the STAI at 5 time points: (1) time of evaluation; (2) post simulation appointment; (3) end of first week of treatment; (4) end of third week of treatment; and (5) end of the fifth week or end of radiation therapy.

Data extracted for end time point.

Standard deviations derived from P value of a t‐test.

Smolen 2002

RCT; 2 parallel groups.

DESCRIPTION: 32 out‐patients undergoing colonoscopy, USA.
NUMBERS: 16 patients in each group.
AGE, mean (SD): Music group = 58.63 (13.64), Control group = 61. 06 (9.48) years old.
GENDER (male/female): Music group = 10/6, Control group = 7/9.
ETHNICITY: Not described.
INCLUSION CRITERIA: Scheduled for ambulatory colonoscopy with an admitting diagnosis of personal history of colorectal cancer, colon polyps, long‐standing ulcerative colitis, or significant family histories of colorectal neoplasia; 18 years and older; conscious, orientated; able to read, write, and speak English; evidenced haemodynamic stability by BP between 90 to 160 mm Hg systolic and 50 to 95 mm Hg diastolic.
EXCLUSION CRITERIA: Taking anti‐anxiety or anti‐depressant medication; unable to engage in verbal conversation throughout the procedure and into the recovery phase.

MUSIC GROUP: Patient choice of classical, jazz, pop rock, easy listening, played via headphones throughout pre‐sedation and procedure.
CONTROL GROUP: Standard care.

SEDATION REQUIREMENTS (mg). Amount of Versed and Demerol administered was recorded (not a primary outcome).
STATE ANXIETY: measured using STAI before and after the procedure.
HR (bpm) and BP (mm Hg): measured using Critikon Model SNK9935 at four time points: on admission, 5 minutes after medication, 5 minutes after procedure, and immediately before discharge. Data presented in graphs, not extracted as unclear what lines represent (e.g. SD or 95% CI).

State anxiety data extracted from graph in article, bars taken as standard errors and converted into SD.

Staricoff 2003f

RCT; 2 parallel groups.

DESCRIPTION: 17 in‐patients with HIV/AIDS staying in the HIV/AIDS ward, London, UK.
NUMBERS: Music group = 8, Control group = 9.
AGE: not described.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: Clinicians performed clinical assessment of hospitalised patients and sent a list of nominated patients to the study personnel for randomisation. No further details given.
EXCLUSION CRITERIA: none described.

MUSIC GROUP: Attended a live music concert played in the public area on the hospital ground floor. Unclear what type of music was played.
CONTROL GROUP: Remained on the ward, where they could not hear the music.

LEVELS OF CD4 AND CD8 LYMPHOCYTES (cells/mm3): measured within one hour before and after the study period.

There was no difference in the number of CD4 cells before and after the concert in either group.

Paper reports that the number of CD8 cells increased in the music group, and remained unchanged in the control group. Table of results suggest that CD8 cells decreased in the control group and increased in the music group.
Change score (post‐pre):
Music group (n = 8) = 77
Control group (n = 9) = −78
Paper reports a t‐test to show statistical significance (P value = 0.01, 95% CI 40 to 269).
Estimated SDs (not reported) = 150

Data insufficient detail.

Tang 1993

RCT; 2 parallel groups.

DESCRIPTION: 120 in‐patients undergoing surgery with epidural anaesthesia in Taiwan.
NUMBERS: 60 patients in each group.
AGE, mean (SD) years: Music group = 42.18 (11.82); Control group = 41.92 (14.22).
GENDER (male/female): Music group = 26/34; Control group = 32/28.
ETHNICITY: not stated.
INCLUSION CRITERIA: To undergo surgery with epidural anaesthesia; ASA grade I‐II.
EXCLUSION CRITERIA: Patients who wish to switch study group. Patients who request tranquillisers.

MUSIC GROUP: Walkman music via headphones. Choice of 5 types (Manderin pop song, local Taiwanese folksong, Western, Classical, Buddhist hymn). Music played throughout operation.
CONTROL GROUP: No music, standard care.

Subjective feelings of anxiety and sedation: Method of assessment unclear (data EXCLUDED from review).
HR (bpm) and BP (mm Hg): Repeated measures (7 time points). Outcomes reported as means and SD taken at baseline and 20 minutes into operation.

Taylor 1998

RCT; 3 parallel groups.

DESCRIPTION: 61 in‐patients who have had an elective abdominal hysterectomy using general anaesthesia in Arizona, USA.
NUMBERS: Unclear how many participants assigned to each group.
AGE, mean (SD): Music group = 40.7 (7.29); Headphones only group = 43.3 (7.79); Control = 34.6 (6.13). The control group were significantly younger than the intervention groups.
GENDER: Female = 61 (100%).
ETHNICITY: not specified.
INCLUSION CRITERIA: All patients scheduled for elective abdominal hysterectomies using general anaesthesia.
EXCLUSION CRITERIA: hearing or visually impaired, unable to communicate in English.

MUSIC GROUP: patient choice brought from home or from selection provided (classical; jazz; light rock; country; rock and roll; easy listening; gospel), played via headphones.
HEADPHONES ONLY GROUP: headphones without music were used to block out unpleasant sounds in the PACU.
CONTROL GROUP: No headphones or music, standard care.
Interventions took place post‐operatively in the PACU.

PAIN INTENSITY: Two measures used: a 9‐inch VAS, and a 10‐point NRS. Measures were taken every 15 minutes for the duration of PACU stay (unspecified). Results of VAS are reported as a mean value for each group; results of NRS are reported as mean rating at 1 hour and at discharge from PACU.

See Cepeda 2006 for details on music for pain relief.

Taylor‐Piliae 2002

RCT; 3 parallel groups.

DESCRIPTION: 30 pre‐operative in‐patients scheduled to undergo cardiac catheterization (CC) in Hong Kong, China.
NUMBERS: 15 patients in each group.
AGE, mean (SD): music group = 56.9 (10.3), control group = 65 (6.9).
GENDER (Male/Female): Music group = 12/3, Control group = 11/4.
ETHNICITY: Chinese = 30 (100%).
INCLUSION CRITERIA: admitted for CC, ethnic Chinese, literate in Chinese, 35 to 75 years old.
EXCLUSION CRITERIA: diagnosed mental illness, major hearing difficulties, life threatening or concomitant major illness (e.g. renal failure/cancer).

SENSORY INFORMATION: excluded from review.
MUSIC GROUP: Instrumental music without words, choice of new age, Chinese instrumental, or classical music.
CONTROL GROUP: standard care.
The study period was 1 hour before CC and lasted for 15 to 20 minutes.

STATE ANXIETY: measured via STAI before and after intervention period;
MOOD: measured via POMS questionnaire.
UNCERTAINTY: measured via Mishel's Uncertainty in Illness Scale.
HR (bpm) taken manually for 1 minute by researcher.
RR recorded manually for 1 minute by researcher.

Outcomes were collected at: (T0) baseline, (T1) after the study intervention (pre‐procedure), and (T2) approximately 1 hour after cardiac catheterization.

Outcomes extracted for T1 ‐ after the study intervention but before cardiac catheterization, as the study has been categorised in the "pre‐procedure" subgroup.

Triller 2006

RCT; 2 parallel groups.

DESCRIPTION: 200 patients undergoing flexible bronchoscopy in Slovenia.
NUMBERS: Music group = 93, Control group = 107.
AGE, mean (SD): Music group = 58.6 (14.9), Control group = 59.6 (14.5) years old.
GENDER (male/female): Music group = 64/29, Control group = 77/30.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: Easy listening and relaxation ambient music selected by the investigator, started immediately after the beginning of the procedure and stopped when the procedure is over.
CONTROL GROUP: Standard care.

Bronchoscopist team asked not to communicate aloud with each other during the procedure.

PHYSIOLOGICAL: HR and BP recorded before and after the procedure, method of data collection not described.

FEELINGS: Overall feelings during the procedure were measured using a VAS. This outcome was not extracted for the review due to questionable validity.

Tsuchiya 2003

RCT; 2 parallel groups.

DESCRIPTION: 59 in‐patients undergoing elective laparoscopic cholecystectomy in an operating theatre in Japan.
NUMBERS: Nature sounds = 29, Control = 30.
AGE, mean (SD): Nature sounds = 65 (10), Control = 66 (9) years old.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: ASA grade I‐II, scheduled for elective laparoscopic cholecystectomy.
EXCLUSION CRITERIA: angina; essential hypertension; auditory perception complications.

NATURE SOUNDS: Patients were played their choice of nature sounds via headphones throughout operation, after induction of anaesthesia until the last suture of surgery.
CONTROL: Patients wore dummy headphones so were exposed to the operating theatre noise. They were not played nature sounds during operation, after induction of anaesthesia until the last suture of surgery.

All patients choose a set of sounds they felt to be calming and comforting in the pre‐operative period. These sounds included familiar Japanese environmental sounds including: sounds of a ripple, a small stream, a soft wind, and a twitter. They all listened to their selected sounds via headphones to determine a comfortable volume. All participants listened to sounds for at least 30 minutes to familiarise themselves with them, prior to operation.

PHYSIOLOGICAL MEASURES: BP and HR was recorded through 'non‐invasive' methods using the Philips patient monitoring system for anaesthesia [unpublished]. Outcomes were measured pre‐anaesthesia, at the start of surgery, at gallbladder removal, at the end of surgery, at extubation, at the end of anaesthesia, and in the PACU.

Patients in the control group had higher BP and HR at extubation than those in the nature sounds group (P value < 0.05). All other time‐points were non‐significant.

EXPERIENCE OF ANAESTHESIA: Unclear validity, 10‐point VAS from 'acceptable' to 'not acceptable'.

Data insufficient detail for extraction. Authors unable to provide means and SDs for physiological measures.

Twiss 2006

RCT; 2 parallel groups.

DESCRIPTION: 60 in‐patients undergoing coronary artery bypass graft or vascular surgery, in the OR and ICU, Florida, USA.
NUMBERS: Music group = 30, Control group = 30.
AGE, mean (SD): Music group = 72.6 (2.1), Control group = 75.1 (3.4) years old.
GENDER (male/female): Music group = 10/20, Control group = 10/20.
ETHNICITY: not described.
INCLUSION CRITERIA: Orientated to person, time, and place on admission; not currently using music therapy intervention; able to hear music played with the CD player; available the night before surgery to meet with investigator and take the baseline STAI.
EXCLUSION CRITERIA: It is UNCLEAR if patients < 65 years old were excluded.

MUSIC GROUP: Choice of 6 discs played during surgery and post‐operatively. Family encouraged to bring in additional music choices post‐operatively. Music selection from Prescriptive Music Inc., ('Clarity'‐ melodies from classical motion pictures; 'Timeless'‐ heartfelt originals, 'Towards'‐ piano improvisation, 'Interlude'‐ piano music by Mozart, 'Universe'‐ synthesized compositions, 'Essence'‐ cello and piano).
CONTROL GROUP: Standard care.

ANXIETY: Measured via the STAI on the 3rd post‐operative day.
INTUBATION TIME: Recorded in minutes.

Voss 2004

RCT; 3 parallel groups.

DESCRIPTION: 61 post‐operative in‐patients following open heart surgery undergoing 30 minutes chair rest, in the surgical intensive care unit of a rural Midwestern hospital, USA.
NUMBERS: Music group = 19, rest group = 21, control group = 21.
AGE, mean (SD): 63 (13) years old.
GENDER (male/female): 39/22.
ETHNICITY (White/American Indian): 52/8.
INCLUSION CRITERIA: 1st post‐operative day following open heart surgery. Morning chair rest ordered. At least 18 years old. No major hearing deficit. Stable condition. Alert, orientated, able to follow commands. Read/write/understand English.
EXCLUSION CRITERIA: Femoral arterial sheath remained in place after surgery.

MUSIC GROUP: Instructed to listen and follow music and allow it to distract and relax. Played through headphones. 6 choices: synthesizer, harp, piano, orchestra ,slow jazz, flute. 30 second excerpts provided for choice. Phone unplugged, blinds closed, lights dimmed and door closed. Do not disturb sign placed on door.
REST GROUP: Phone unplugged, blinds closed, lights dimmed and door closed. Do not disturb sign placed on door.
CONTROL GROUP: Activity as normal.

ANXIETY: Anxiety about chair rest measured via 100 mm VAS.
PAIN SENSATION: measured via 100 mm VAS.
PAIN DISTRESS: measured via 100 mm VAS.

Change scores extracted for anxiety.

See Cepeda 2006 for details on music for pain relief (study not included in Cepeda 2006).

Wang 2002

RCT; 2 parallel groups.

DESCRIPTION: 93 pre‐surgical out‐patients, to undergo elective surgery (ear‐nose‐throat; orthopedics; plastics; or other general minor surgery), in USA.
NUMBERS: Music group = 48, Control group = 45.
AGE, mean (SD): Music group = 44 (11), Control group = 41 (11) years old.
GENDER (male/female): Music group = 56/44, Control group = 61/39.
ETHNICITY (White/African‐American/Other): Music group = 38/8/2, Control group = 37/6/2.
INCLUSION CRITERIA: Aged 18 to 65 years old; ASA grade 1 to 3; Scheduled to undergo anaesthesia and elective out‐patient surgery.
EXCLUSION CRITERIA: none described.

MUSIC GROUP: Music played for 30 minutes via headphones prior to surgery in a hospital isolation room. Participants brought their own choice of music from home.
CONTROL GROUP: Wore headphones but did not listen to any music or white noise. In hospital isolation room. Condition lasted 30 minutes.

No hospital personnel were allowed in the room during the experiment. The experimenter waited outside the room. Persons accompanying the participant were allowed in the room, and participants were allowed to read and converse during the experiment.

ANXIETY: Measured via STAI before and after experiment.
HR: Measured via Biolog monitoring system.
BP: Method of measurement unclear.
SKIN CONDUCTANCE: Continually monitored with a Biolog ambulatory recording system (Model 3992/2).
HORMONES: Plasma catecholamines (cortisol, epinephrine, and norepinephrine) were obtained before and after experimental condition via blood sampling. Outcomes were obtained through radioimmunoassay then through high‐performance liquid chromatography and an electrochemical detector.

Outcomes are expressed as a percentage of the baseline score (mean and SD).

White 1992

RCT; 2 parallel groups.

DESCRIPTION: 40 in‐patients in acute care unit for acute myocardial infarction in Midwest USA.
NUMBERS: 20 patients per group.
AGE, mean (SD): 55.7 (7.57) years old.
GENDER (male/female): 29/11.
ETHNICITY (Euro‐American/African‐American): 36/4.
INCLUSION CRITERIA: Stable condition; confirmed diagnosis of acute MI; State anxiety > 40; Alert and orientated; Able to read and write English.
EXCLUSION CRITERIA: Interrupted during the study.

MUSIC GROUP: listened to 4 adagios selected by the investigator for 25 minutes. Primarily string composition, low‐pitched, simple and direct musical rhythm, tempo approximately 60 bpm. Played via headphones.
CONTROL GROUP: received 25 minutes of uninterrupted rest.

ANXIETY: state anxiety measured via STAI.
HR and RR measured by auscultation for 30 seconds.

White 1999

RCT; 3 parallel groups.

DESCRIPTION: 45 in‐patients who had an acute MI, in private rooms in an ICU in Midwest USA.
NUMBERS: 15 patients per group.
AGE: mean = 63 years old.
GENDER (male/female): Music group = 13/2, Rest group = 10/5, Control group = 11/4.
ETHNICITY (African‐American/White/Hispanic): Music group = 2/13/0, Rest group = 4/10/1, Control group = 2/12/1.
INCLUSION CRITERIA: Confirmed acute MI within previous 72 hours; haemodynamic condition stable enough for participation (determined by nurse); alert and orientated; primary cardiac rhythm originating from the sinoatrial node.
EXCLUSION CRITERIA: Receiving mechanical ventilation.

MUSIC GROUP: Experimenter selected classical music, played via headphones. Asked to assume a comfortable position in bed, lights lowered, telephones unplugged, curtains drawn, doors closed, advised to clear mind and let muscles relax. 20 minutes.
REST GROUP: 20 minutes uninterrupted rest (experimenter outside door). Asked to assume comfortable position in bed, lights lowered, telephones unplugged, curtains drawn, doors closed, advised to clear mind and let muscles relax.
CONTROL GROUP: activities as normal (standard care).

PHYSIOLOGICAL: HR (chart extraction), RR (auscultation with a stethoscope for 30 seconds), BP (non‐invasive automatic oscillometric BP cuff), measured pre, immediately post and at 1 and 2 hours post the intervention period. Heart rate variability determined using power spectral analysis and fast Fourier transform from 3 hours of continuous electrocardiographic data (30 minutes pre to 2 hours post intervention period).
ANXIETY: Measured via state portion of STAI pre and immediately post intervention.

Data presented as mean and SE. SEs converted into SDs for purposes of review.

Data extracted for measures immediately after 20 minute intervention period.

Data extracted for HR, RR, BP, and anxiety, for purposes of review. Data not extracted for Rate pressure product or high‐frequency HR.

Winter 1994

RCT; 2 parallel groups.

DESCRIPTION: 50 day patients scheduled for elective same‐day surgery of gynaecological procedures (e.g. exploratory laparoscopies, laparoscopic tubal ligation, ovarian cysts excision, and intrauterine device removal), in New Jersey, USA.
NUMBERS: Music group = 31 patients, Control group = 19 patients.
AGE, mean (SD): Music = 37 (8), Control = 37 (8).
GENDER: Female = 50 (100%).
ETHNICITY: not stated.
INCLUSION CRITERIA: Not described.
EXCLUSION CRITERIA: Not described.

MUSIC GROUP: Choice of classical, country, jazz, popular, or show music, played via headphones.
CONTROL GROUP: Standard care.
The intervention period took place in the surgical holding area prior to the patients' gynaecological procedure. Pre‐operative stay in holding area was 50 (+/‐ 20) minutes.

ANXIETY: State and trait anxiety via STAI on entry and exit of holding area. Results reported as Mean +/‐ SEM.
BP and HR: Taken on arrival in the surgical holding area and again just before going to the Operating Room (secondary outcomes).

Anxiety data presented as mean and SEs. SEs converted into SDs for purposes of review.

Wong 2001

RCT; cross‐over study (2 allocation groups).

DESCRIPTION: 20 ventilator‐dependent in‐patients in an ICU in Hong Kong, China.
NUMBERS: Music group = 20 patients, Scheduled rest = 20 patients (cross‐over design).
AGE, mean (SD): 58.25 (15.53) years old.
GENDER (male/female): 15/5.
ETHNICITY: Chinese = 20 (100%).
INCLUSION CRITERIA: Chinese; understand Cantonese or English; 18 to 85 years old; alert, mentally competent; without hearing problems; able to communicate by holding up fingers in response to researchers' questions; undergoing mechanical ventilation with self‐triggering; haemodynamically stable.
EXCLUSION CRITERIA: Receiving any continuous intravenous analgesia; receiving any inotropic support; enrolled in previous similar studies.

MUSIC GROUP: Choice of 7 cassettes (Chinese folk song; Chinese instrumental music; Chinese music with western instruments; Buddhist music; Western classic; Western movie music; piano music). Participants instructed to close eyes and focus on the flow of the music.
SCHEDULED REST GROUP: Dimmed lights, drawn curtains (if in cubicle) or closed door (if in single room). Instructed to close eyes and rest.

Interventions lasted 30 minutes with an interval of at least 6 hours between the two interventions. Visitors were allowed to stay during the experimental and control interventions.

STATE ANXIETY: short‐form STAI, patients held up appropriate number of fingers in response to questions. Taken before and after each intervention.
RR: breaths per minute counted via observation.
BP (mm Hg): measured with the means of indwelling arterial lines recorded on the bedside cardiac monitor.

RR and BP recorded every 5 minutes during intervention periods (7 measurement points).

This cross‐over study has not reported patient‐specific differences between the two intervention measurements. Therefore, the data has been extracted as if it is independent groups (as there was not enough data to calculate a correlation coefficient).

Yang 2003

RCT; 2 parallel groups.

DESCRIPTION: 39 patients undergoing eye operations with anaesthetics and analgesics in China.
NUMBERS: Music group = 19 patients; Control group = 20.
AGE, mean years: Music group = 39; Control group = 37.
GENDER: Male = 39 (100%).
ETHNICITY: not stated.
INCLUSION CRITERIA: 18 to 60 years old, with a baseline anxiety score of more than 40.
EXCLUSION CRITERIA: not stated.

MUSIC GROUP: Given a choice of 3 musical styles (pop, light, classical) with each type including 4 songs. Patients were asked to listen to the music 2 to 3 times the night before the operation and relax (not clear if patients were in‐patients). Patients then listened to the music throughout their operation.
CONTROL GROUP: Were given a pre‐operative visit but were not given a music tape. These patients received standard care during their operation.

ANXIETY: STAI presented as change scores.
DEPRESSION: Self‐rating Depression Scale (SDS) presented as change scores.
CONCERN / WORRY: via VAS (0 to 10) taken before, during, and after surgery.
BI: Bispectral Index measured via EEG.

Yung 2003

RCT; 2 parallel groups.

DESCRIPTION: 66 pre‐operative surgical patients in the OR holding area in Hong Kong, China.
NUMBERS: 33 patients in each group.
AGE, mean (range): 64.7 (21 to 89) years old.
GENDER: Male = 66 (100%).
ETHNICITY: Chinese = 66 (100%).
INCLUSION CRITERIA: Volunteer surgical patients; 50 to 80 years old (this does not reflect age range provided in table); comprehend written and verbal instructions; have prior surgical experience.
EXCLUSION CRITERIA: auditory impairment; received preoperative sedation; cardiac and respiratory disease; history of hypertension.

MUSIC GROUP: Slow music played via headphones for 20 minutes pre‐operatively. Participants had a choice of 3 tapes‐ Chinese instrumental, Western instrumental, or Western and Chinese slow songs.
CONTROL GROUP: Standard care.

ANXIETY: State anxiety measured via C‐STAI pre‐ and post‐intervention period.
PHYSIOLOGICAL: BP and HR measured with an automated monitor (Dinamap 1846‐SX) before and after intervention period. RR measured through observing the number of chest movements.

Zhang 2005

RCT; 2 parallel groups.

DESCRIPTION: 110 in‐patients undergoing abdominal hysterectomy in China.
NUMBERS: 55 patients in each group.
AGE, mean (SD): Music group = 41 (5) years old; Control group = 41 (3) years old.
GENDER: Female = 110 (100%).
ETHNICITY: not described.
INCLUSION CRITERIA: ASA I‐II; scheduled for elective total abdominal hysterectomy under spinal‐epidural anaesthesia.
EXCLUSION CRITERIA: Hearing impairment; drug abuse; known psychiatric disorders or memory disorders.

MUSIC GROUP: Patient choice of music they felt to be calming and comforting, played via headphones intraoperatively, from 6 minutes before skin incision and 1 minute before the loading dose of anaesthesia to wound closure
CONTROL GROUP: Wore headphones without sound or music.

PHYSIOLOGICAL: BP, HR, Bispectral Index recorded at 10‐minute intervals during surgery. Results reported as baseline and mean score during surgery (during target sedation period).
SEDATION: Level of alertness graded using the OAA/S at 10‐minute intervals. Time to sedation (OAA/S score = 3) reported (mins).
PROPOFOL: amount of intra‐operative propofol (mg) recorded.
SATISFACTION: patient's satisfaction with the peri‐operative care measured using a 10 cm VAS one day after surgery.
SERUM INTERLEUKIN‐6: measured at 3 time intervals (before, immediately after, and 1 hour after intervention). Determined using radioimmunoassay kits.

See Cepeda 2006 for details on music for pain relief (study not yet included in Cepeda 2006).

Zimmerman 1988

RCT; 3 parallel groups.

DESCRIPTION: 75 in‐patients with suspected myocardial infarction in a coronary care unit in Midwest USA.
NUMBERS: 25 participants in each group.
AGE, mean: Music group = 65, Control group = 72, White noise group = 59. Overall mean (range) = 65 (34 to 92) years old.
GENDER (male/female): 49/26
ETHNICITY: White = 75 (100%).
INCLUSION CRITERIA: Orientated to person, place, and time; English speaking; > 19 years old; Stable condition.
EXCLUSION CRITERIA: Hearing deficit; Health professional background.

MUSIC GROUP: 30 minutes of self‐selected music choice of instrumental tapes: Halpern relaxation tape, classical music, country and western. Played via headphones.
WHITE NOISE GROUP: 30 minutes of white noise played via headphones.
CONTROL GROUP: Standard care. Were told the study was for gaining information about new admissions. Asked to lay quietly in bed for 30 minutes.

The music and white noise groups were told the tapes were to relax them.

ANXIETY: state anxiety measured via STAI
PHYSIOLOGICAL: BP and HR measured via an automatic monitor (Kendall Co., Model 8200). Skin temperature monitored by a digital thermometer (No. 865; Omega Engineering Inc.).

Zimmerman 1989

RCT; 2 parallel groups.

DESCRIPTION: 40 in‐patients with chronic cancer pain in acute care, Midwestern USA.
NUMBERS: 20 patients per group.
AGE, mean (range): 60 (34 to 79) years old.
GENDER (male/female): 16/24.
ETHNICITY (white/other): 39/1.
INCLUSION CRITERIA: orientation to person time and space; English speaking; 19 years or older; ability to consent verbally and in writing; experiencing pain for > 6months; receiving a scheduled (e.g. every 3 or 4 hours round‐the‐clock) pain medication; free of major hearing deficit.
EXCLUSION CRITERIA: no further criteria described.

MUSIC GROUP: Choice of 10 relaxing instrumental tapes. Participants without a preference were given a Halpern antifrantic tape. The researcher suggested to the participant that the music would help them relax and reduce their pain. Participants listened to the music for 30 minutes via headphones. Participants lay on their beds and the lights were dimmed.
CONTROL GROUP: Patients lay on their beds for 30 minutes with the lights dimmed.

PAIN: Measured before and after 30 minute test period via McGill Pain Questionnaire (Pain Rating Index, Number of Words Chosen, and Present Pain Index). Additionally, pain intensity was measured via a 10 mm [sic] VAS.

See Cepeda 2006 for details on music for pain relief.

BP: blood pressure; HR: heart rate; PACU: post‐operative care unit; POMS: Profile of Mood States; RR: respiration rate; SD: standard deviation; STAI: State Trait Anxiety Inventory; VAS: visual analogue scale; VRS: verbal rating scale;

Figures and Tables -
Table 8. Music [RCT]: Characteristics of included studies
Table 9. Music [CCT]: Characteristics of post‐hoc exclusions (non‐randomised studies)

Study ID

Methods

Participants

Interventions

Outcomes

Notes

Augustin 1996

CCT; 2 parallel groups;
Allocated by alternation;
Blinding: NOT DONE;
Unit of allocation same as unit of analysis: DONE;
Power calculation: NOT DONE;
Outcomes obtained for >80% of patients: UNCLEAR;
Groups similar at baseline: DONE;
Protection against contamination: UNCLEAR;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 42 pre‐operative patients scheduled for ambulatory surgery in a Midwestern city hospital, USA.
NUMBERS: 21 patients per group.
AGE, mean (range): 47 (18‐73) years old.
GENDER (Male/Female): 25/17
ETHNICITY: All Caucasian.
INCLUSION CRITERIA: Any patient scheduled for ambulatory surgery who is over 15 years old.
EXCLUSION CRITERIA: Cognitive disability/delay; scheduled for cataract removal; hearing impairment; received a pre‐operative sedative; received colon preparation; lack sufficient time to participate.

MUSIC GROUP: Choice of 20 tapes (classical, environmental, new age, country‐western, general easy listening), played via headphones whilst resting in recliner chairs. Intervention lasted 15‐30 minutes depending on how long patient had left before surgery.
CONTROL GROUP: Standard care‐ not offered music. Activities were not monitored, friends and family may have been present, rooms contained magazines and a television.

PHYSIOLOGICAL MEASURES: measured using "standard noninvasive technology" before and after the intervention period.
RR (non‐significant):
Music group = 15.10 (2.28)
Control group = 16.00 (1.75)
BP (Non‐significant):
Music group: Systolic = 126.00 (15.47), Diastolic = 78.90 (12.54).
Control group: Systolic = 130.50 (17.14), Diastolic = 83.90 (9.45).
HR (Mean difference = ‐5.90, 95% CI = ‐11.56, ‐0.24):
Music group = 67.20 (8.87)
Control group = 73.10 (9.83).
ANXIETY: State anxiety measured using the STAI before and after intervention period. Non‐significant:
Music group = 35.38 (9.44)
Control group = 33.42 (9.62)

Binek 2003

CCT; 2 parallel groups;
Allocated by alternation;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: DONE;
Power calculation: UNCLEAR;
Outcomes obtained for >80% of participants: UNCLEAR;
Groups similar at baseline: demographics‐ DONE;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 301 outpatients and inpatients undergoing colonoscopy or esophagogastroduodenoscopy (EGD) in Switzerland.
NUMBERS: Music group = 151, Control group = 150.
AGE, mean: 59 years old.
GENDER (male/female): 173/128.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: Inability to answer questions due to severe illness, impaired consciousness, impaired hearing, and emergency interventions.

MUSIC GROUP: Patients could choose between "light" and "classical" music which was played in the background during the examination.
CONTROL GROUP: Standard care.

GENERAL EVALUATION: Not extracted for review.
PAIN SENSATION: Measured via 100mm VAS. No significant difference.
Music group: Mean (SD) = 7.66 (2.40),
Control group: Mean (SD) = 7.86 (2.45).
TOLERANCE OF PROCEDURE: Not extracted for review.
ROOM AMBIENCE: Not extracted for review.
SEDATION: Amount of midazolam and pethidine received was recorded, no significance difference between groups.
Pethidine:
Music group = 36.07 (18.88)
Control group = 37.10 (18.18)
Midazolam:
Music group = 3.01 (1.46)
Control group = 2.76 (1.37)

Paper reports outcomes as medians. Authors provided means and standard deviations on request for purposes of review.

Brunges 2003

CCT; 2 parallel groups;
Allocation method: UNCLEAR;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: UNCLEAR;
Unit of allocation same as unit of analysis: UNCLEAR;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: UNCLEAR;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 44 pre‐operative in‐patients in the holding area before total joint replacement, in Florida, USA.
NUMBERS: Graph depicts 22 patients in the music group and 21 patients in the control group (one person missing).
AGE, range: 39‐81 years old.
GENDER (male/female): 23/21
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: Listened to music via headphones for a minimum of 30 minutes in the pre‐operative holding area. Music consisted of music‐enhanced nature sounds (sea, thunder, rainstorms, wind, and waterfalls).
CONTROL GROUP: Standard care.

The paper provides descriptive statistics only.
EPINEPHRINE: Sampled via indwelling catheter lines. Results given as a range:
Music group = 5‐10 mcg
Control group = 8‐32 mcg
LENGTH OF STAY: Presented in a bar chart. Means and SDs derived from the bar chart (NB. Two participants in the control group stayed for > 7 days, to calculate the mean and SD for this group, it was assumed these participants stayed for 7 days, thus providing a conservative estimate of the mean and SD):
Music group (n = 22) = 4.14 (0.83) days
Control group (n = 21) = 4.76 (1.18) days
A t‐test on this derived data provides a P value of 0.052 (95% CI = ‐1.25 to 0.01).

Dubois 1995

CCT; 2 parallel groups;
Allocated by medical record number (odd numbers were assigned to music, even numbers assigned to control);
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: DONE;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: DONE;
Groups similar at baseline: demographics‐ DONE;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: DONE (3 patients refused music).

DESCRIPTION: 49 out‐patients undergoing bronchoscopy, USA.
NUMBERS: Music group = 21, Control group = 28.
AGE, mean (SD): Music group = 56 (14), Control group = 54 (17) years old.
GENDER (male/female): Music group = 12/9, Control group = 16/12.
ETHNICITY: not described.
INCLUSION CRITERIA: Bronchoscopy patients; understand English.
EXCLUSION CRITERIA: none stated.

MUSIC GROUP: Played new wave music 'Reflections of Passion' by Yanni, via headphones for the duration of bronchoscopy procedure.
CONTROL GROUP: Standard care.

PHYSIOLOGICAL: Methods of obtaining data unclear. There were no significant differences between groups on any of the physiological parameters.
Oxygen saturation:
Music group = 92 (5)
Control group = 93 (3)
HR:
Music group = 104 (19)
Control group = 101 (22)
BP:
Music group: systolic BP = 154 (27), diastolic BP = 89 (13)
Control group: systolic BP = 152 (24), diastolic BP = 95 (24)
COMFORT: Measured via 'Borg Scale', validity unclear.
MEDICATION INTAKE: Amount of midazolam consumed did not differ between groups.
Music group = 2.81 (1.58) mg
Control group = 3.19 (2.12) mg.

Dzhuraeva 1989

CCT; 2 parallel groups;
Method of allocation: UNCLEAR;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: UNCLEAR;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: UNCLEAR;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 158 inpatients with cardiovascular and respiratory illnesses participating in a therapeutic exercise programme, in the Republic of Uzbekistan.
NUMBERS: unclear how many patients per group. There were 69 cardiovascular patients, and 89 respiratory patients included in the study.
AGE: 30‐55 years old.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: Were played classical and pop music during the two week exercise programme.
CONTROL GROUP: Were not played music during the exercise programme.

The exercise programme was tailored to the physical and functional readiness of the participants, with the same protocol applied to both the music and control groups. Respiratory patients received additional training on breathing when stationary and during exercise.

PULSE: Assessed increase in pulse rate during exercise in the first and second weeks of the exercise programme. Method of data collection unclear. In week one, the music group worked harder, as demonstrated by increased pulse.
Cardiovascular patients:
Music group = 50.3 (2.89); Control group = 33.1 (1.54)
Respiratory patients:
Music group = 58.1 (1.66); Control group = 47.2 (1.93)
In week two, the clinical groups showed more similar patterns, and the music group had adapted better to the exercise.
Cardiovascular patients:
Music group = 30.3 (4.12); Control group = 40.5 (3.07)
Respiratory patients:
Music group = 34.1 (2.23); Control group = 43.2 (2.86)
OBSERVATIONS: Complaints, sweating, skin colour, respiration, co‐ordination. Details unclear.
Cardiovascular patients adapted better to the exercise in week one with music, as compared to respiratory patients who showed greater unpleasant reactions, disruptive breathing patterns, and sweating. By the second week of exercise, respiratory patients in the music group were demonstrating better adaptation to exercise than controls.

Authors conclude that cardiovascular patients should use music from the 1st week of exercise, and respiratory patients should use music from the 2nd week of exercise for better adaptation.

Evans 1994

CCT; 2 parallel groups;
Allocated systematically (3 to music group then 1 to control group);
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Power calculation: NOT DONE;
Outcomes obtained for > 80% of participants: DONE;
Groups similar at baseline: Trait anxiety ‐ DONE, other characteristics‐ UNCLEAR;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 24 pre‐operative day surgery patients waiting for surgery under general anaesthesia, in Texas, USA.
NUMBERS: Music group = 18, Control group = 6.
AGE, mean (SD): Music group = 52.67 (11.74), Control group = 43.50 (7.56) years old.
GENDER (male/female): Music group = 8/10, Control group = 1/5.
ETHNICITY: not described.
INCLUSION CRITERIA: Read and speak English; Scheduled for endoscopic cholecystectomy, herniorrhaphy, or appendectomy under general anaesthesia.
EXCLUSION CRITERIA: none described.

MUSIC GROUP: Choice of "easy listening" music selections recorded by the medical staff played via headphones for 20 minutes pre‐operatively.
CONTROL GROUP: Standard care.

Both groups were encouraged to close their eyes or cover them with a cloth.

ANXIETY: Measured via the STAI and a VAS. There was no significant difference between groups on either measure. STAI:
Music group = 33.2
Control group = 34.0
BP: Method of measurement UNCLEAR. There was no significant difference between groups:
Music group: Systolic BP = 125.6 (13.2), Diastolic = 79.8 (12.6)
Control group: Systolic BP = 128.5 (22.7), Diastolic = 74.5 (8.0)
PULSE: Method of measurement UNCLEAR. There was no significant difference between groups:
Music group = 75 (12.8)
Control group = 78 (6.9)

Guétin 2005

CCT; 2 parallel groups;
Allocated by month of admission;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: NOT DONE;
Power calculation: DONE;
Outcomes obtained for >80% of participants: DONE;
Groups similar at baseline: DONE;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: DONE (3 from music group, 2 from control group).

DESCRIPTION: 65 in‐patients undergoing rehabilitation (physiotherapy, balneotherapy, re‐education, and physical exercise) for lower back pain, France.
NUMBERS: Music group = 33, Control group = 32.
AGE: not described.
GENDER (male/female): Music group = 16/17, Control group = 16/16.
ETHNICITY (French/European/African): Music group = 28/2/3, Control group = 28/2/2.
INCLUSION CRITERIA: 30‐70 years old; speak and read French; not cognitively impaired; diagnosis of lower back pain for > 6 months.
EXCLUSION CRITERIA: deafness; epilepsy around auditory stimuli; infectious/inflammatory back pain.

MUSIC GROUP: Music provided for first 4 days of 12 day hospitalisation. Music played for 20 minutes in the afternoon after physical therapy via headphones in a silent room. Patients were given a choice of music, with each choice arranged to have progressive relaxation with re‐awakening period at the end.
CONTROL GROUP: Received physical therapy alone, with no music sessions.

PAIN: Measured via VAS at baseline, day 5, and day 12, plus immediately pre and post therapy sessions. Day 5 outcomes did not significantly differ between groups:
Music group = 3.7 (2.7), Control group = 4.0 (2.0).
DEPRESSION/ANXIETY: Measured via the Hospital Anxiety and Depression (HAD) scale (scores from 0‐21 with higher scores indicating more depression/anxiety). Paper reports the music group had significantly reduced scores from baseline to Day 5 on depression and anxiety when compared to the control group:
Depressoin (change score):
Music group = ‐2.1 (3.0), Control group = 0.6 (2.4)
Anxiety (change score):
Music group = ‐3.5 (3.7), Control group = 2.5 (9.4)
FUNCTIONAL ABILITY: Measure with the Oswestry index (scores from 0‐50 with higher scores indicating more disability). Paper reports that music group had significantly reduced scores from baseline to Day 5 when compared to the control group:
Music group = ‐11.8 (17.8), Control group = ‐2.5 (9.4)

Hamel 2001

CCT; 2 parallel groups;
Allocated via alternation;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: DONE;
Power calculation: DONE;
Outcomes obtained for > 80% of participants: NOT DONE;
Groups similar at baseline: gender‐ DONE, outcomes ‐ NOT DONE;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: DONE (36 left prior to completing the STAI, 2 disliked music, 2 did not want to retake STAI).

DESCRIPTION: 101 in‐patients and out‐patients waiting for cardiac catheterizations in a cardiac telemetry unit, USA.
NUMBERS: Music group = 51, Control group = 50.
AGE, range: 43‐74.
GENDER (male/female): Music group = 34/17, Control group = 29/21.
ETHNICITY: not described.
INCLUSION CRITERIA: Orientated to person, place and time; read and speak English; free of hearing deficit.
EXCLUSION CRITERIA: none stated.

MUSIC GROUP: Listened to 20 minutes of 'Trance‐Zendance' by Halpern. Played via headphones prior to cardiac catheterization.
CONTROL GROUP: Standard care.

ANXIETY: Measured via STAI pre‐ and post‐ 20‐minute intervention period. There was a significant difference in anxiety scores in favour of the music group:
Music group = 37.84 (9.82)
Control group = 44.34 (10.99)
HR: Measured manually by counting heart beats from the radial artery or automatically with a Marquette Component Monitor. There were no significant differences between groups on HR:
Music group = 64.43 (12.00)
Control group = 67.56 (19.43)
BP: Measured via an automatic noninvasive oscillometric cuff, or using a sphygmomanometer auscultating over brachial artery. Paper reports a significant increase in systolic BP in the control group from baseline. There was not a significant difference between groups post‐treatment.
Music group: Systolic BP = 133.53 (19.79), Diastolic BP = 72.78 (10.91)
Control group: Systolic BP = 139.72 (21.61), Diastolic BP = 75.52 (11.94)

Haun 2001

CCT; 2 parallel groups;
Allocated via alternation;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: DONE;
Power calculation: NOT DONE;
Outcomes obtained for >80% of participants: UNCLEAR;
Groups similar at baseline: demographics ‐ DONE, outcomes ‐ UNCLEAR;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 20 pre‐operative patients scheduled for breast biopsy in a holding area in Kentucky, USA.
NUMBERS: 10 patients in each group.
AGE, mean (SD): Music group = 39.7 (13.2), Control group = 37.2 (12.7) years old.
GENDER: 100% female.
ETHNICITY: not described.
INCLUSION CRITERIA: none described.
EXCLUSION CRITERIA: Hearing impairment; history of cancer surgery; hypertension; cardiac disease; pulmonary disease; on medication for any of the above conditions; excluded by attending surgeon.

MUSIC GROUP: Choice from selection of "new age" music listened to via headphones for 20 minutes pre‐operatively. No other music types were offered and patients' preferences were not solicited.
CONTROL GROUP: Standard care.

Family members encouraged to be with both groups once nursing staff had completed all necessary pre‐operative care.

ANXIETY: Measured via the STAI pre‐ and post‐ 20‐minute study period.
Significant difference found in favour of music group:
Music group = 32.8 (7.0)
Control group = 46.6 (9.3)
PHYSIOLOGICAL: BP and HR measured via Spacelab monitor immediately pre‐ and post‐ 20‐minute study period. RR measured via experimenter observation. No differences observed between groups for BP and HR. A significant difference was observed in favour of music group for RR.
BP:
Music group: Systolic BP = 118.0 (14.3), Diastolic BP = 69.0 (10.4)
Control group: Systolic BP = 121.7 (15.9), Diastolic BP = 71.2 (10.6)
HR:
Music group = 77.4 (16.0); Control group = 79.7 (13.6)
RR:
Music group = 16.4 (2.1); Control group = 18.4 (2.1)

Heiser 1997

CCT; 2 parallel groups;
Patients matched for gender and age;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Power calculation: NOT DONE;
Outcomes obtained for >80% of participants: NOT DONE;
Groups similar at baseline: Gender and age‐ DONE, outcome measures‐ UNCLEAR;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: DONE for 15 patients (anaesthesia care providers unable to adhere to the intraoperative anaesthesia study protocol for 6 patients, 8 patients had incomplete data, 1 patient who had denied alcohol abuse preoperatively admitted this postoperatively). A further 9 patients were not included in analysis, presumably due to matched pairing, although this is UNCLEAR.

DESCRIPTION: 34 in‐patients undergoing elective lumbar microdiscectomy procedures consented to participate (although only 10 analysed), Kentucky, USA.
NUMBERS: Music group = 5 patients analysed, Control group = 5 patients analysed.
AGE, mean (range): Original 34 participants = 38 (23‐59) years old.
GENDER (male/female): 21/13.
ETHNICITY: not described.
INCLUSION CRITERIA: ASA status I‐II; scheduled for elective lumbar microdiscectomy procedures.
EXCLUSION CRITERIA: History of substance abuse; psychological disorders; > 40% over ideal body weight; had incurred lumbar spine injuries with other traumatic injuries; history of chronic pain.

MUSIC GROUP: Participants had a choice of 3 cassettes (country, instrumental, classical), with music 60‐80 bpm, played via headphones at a volume pre‐selected by participants. Music began 30 minutes before the end of the surgery and continued without interruption for one hour in PACU.
CONTROL GROUP: Also selected preferred music and checked sound level pre‐operatively, but were not played any music during surgery or in the PACU.

No data reported in paper. The paper reports there were no differences between the two groups on any of the outcome measures.

ANALGESICS: Amount of IV morphine sulfate administered.
PAIN and ANXIETY: Measured via VAS.

Kaempf 1989

CCT; 2 parallel groups;
Allocation by alternative weeks;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: NOT DONE;
Power calculation: NOT DONE;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: UNCLEAR;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 33 out‐patients awaiting arthroscopic procedures in Philadelphia, USA.
NUMBERS: UNCLEAR, paper states that recruitment continued until there were at least 15 patients in each group.
AGE: not described.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: 18 years or older; understand written and verbal instructions.
EXCLUSION CRITERIA: received sedation prior to arriving in the holding area.

MUSIC GROUP: 20 minutes of classical music (tape 3 of Music Rx, developed by Bonny), played via audiocassette played placed 1 foot away during the waiting period.
CONTROL GROUP: Standard care.

BP: Measured via a Dinamap monitor before and after the 20 minute study period. There were no significant differences between the groups. Standard deviations are not provided.
Music group: Systolic BP = 122.3 mm Hg, Diastolic BP = 73.1 mm Hg.
Control group: Systolic BP = 124.6 mm Hg, Diastolic BP = 74.7 mm Hg.
RR: Method of measurement unclear. There was a significant difference in favour of the music group (P = 0.047). No standard deviations provided.
Music group = 15.2
Control group = 19.0
ANXIETY: Measured via STAI before and after intervention period. There was no significant difference between the groups. No standard deviations provided.
Music group = 32.7
Control group = 35.8

Lee 2004b

CCT; 2 parallel groups;
Allocation by day of procedure;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: NOT DONE;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: Physiological measures (DONE), STAI (NOT DONE).
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 113 pre‐operative day patients undergoing cytoscopy, cauterisation, or endoscopy, in China (Hong Kong).NUMBERS: Music group = 58, Control group = 55.AGE, mean (SD): Music group = 50.0 (15.5), Control group = 51.9 (14.4) years old.GENDER (male/female): Music group = 31/27, Control group = 27/28.ETHNICITY: not described.INCLUSION CRITERIA: 18 years or older; undertaking noninvasive day procedures with regional or local anaesthetic.EXCLUSION CRITERIA: Cognitive disability; hearing impairment; received preoperative sedatives; received a colon preparation; pre‐existing co‐morbid illness; did not have sufficient time to participate.

MUSIC GROUP: Choice of eastern and western style easy listening music and Chinese pop music (10 CDs and 10 mini‐discs) played via headphones in reclining chairs for 20‐40 minutes pre‐operatively.CONTROL GROUP: Undertook usual pre‐procedural relaxing activities (e.g. reading, watching TV) in the waiting room.

STATE ANXIETY: Measured via STAI pre‐ and post‐intervention period. Only the music group had a significant drop in anxiety. Post‐intervention scores:Music group = 42.5 (5.7) Control group = 46.4 (6.5) PHYSIOLOGICAL OUTCOMES: Measured via "standard non‐invasive instruments" pre‐ and post‐intervention period. There were no significant differences between groups.BP scores: Music group: Systolic BP = 124.2 (21.1), Diastolic BP = 70.0 (10.8) Control group: Systolic BP = 129.4 (25.6), Diastolic BP = 72.0 (11.1) PULSE scores: Music group = 71.1 (10.4) Control group = 70.1 (8.6) RR:Music group = 16.6 (1.0) Control group = 16.7 (1.0)

Metera 1975a

CCT; 2 groups (non‐parallel), intervention group was cross‐over (2 types of music played in same order for all participants), control group may have been recruited post‐hoc (UNCLEAR).
Allocation method: Participants appear to have been recruited to intervention group first, and control participants recruited after‐ UNCLEAR.
Blinding of group allocation: NOT DONE
Blinded assessment of outcomes: UNCLEAR if automated;
Power calculation: UNCLEAR;
Outcomes obtained for >80% of participants: UNCLEAR;
Groups similar at baseline: UNCLEAR;
Protection against contamination: NOT DONE‐ cross‐over in music group. DONE for control group.
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 45 patients with disease of the lungs or chest being treated at the Department of Chest Surgery in Zakopane, Poland.
NUMBERS: Music group = 30, Control group = 15.
AGE, mean (range): Music group = 34 (19‐62) years old, Control group not described.
GENDER (male/female): Music group = 25/5, Control group not described.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: Cross‐over study. Music was played via headphones. Patients were played Debussy's 3rd part of Bergamasque Suite (Clair de Lune) on the piano (soothing music), and then Bartok's Wonderful Mandarin (nerve racking/exciting music). First, there was a 3‐minute rest in the recumbent position then, before, in between, and after each musical piece was a 3‐minute pause.
CONTROL GROUP: Received no music.
No specific treatment/surgery was being given to any participants during the experiment.

Parameters were measured at 5 time points in the music group: 1) Following 3‐min rest; 2) Following soothing music; 3) Following 3‐min pause; 4) Following exciting music; 5) Following 3‐min pause. Parameters were measured at 4‐time points in the control group (to follow same time scale as the music group)‐ a final 5th measurement was not taken for the control group.
Paper states "No statistically significant differences were found in any of these parameters between the experimental and the control group".
RESPIRATORY RATE: No significant differences within the music group.
TIDAL VOLUME: Within the music group there was significant differences between the 1st and 2nd measurements (639 ml and 527 ml) only.
MINUTE VENTILATION: Within the music group there was a significant difference (P <0.1) [sic] between the 1st and 2nd measurements (11l and 8.9l). Measurements during exciting music showed a rise in MV almost to the initial value (4th measurement = 10.6l).
MINUTE OXYGEN CONSUMPTION: Within the music group there was a significant decrease between the 1st and 2nd measurements (315 ml and 282 ml). There was an increase of 60 ml during the exciting music (significance unclear).
BASAL METABOLIC RATE: Within the music group there was a significant decrease between the 1st and 2nd measurements (42% and 24 %). Exciting music increased BMR to 53.5% ("significant even at P < 0.1" [sic]).
HEART RATE: No significant differences within the music group.

Data not sufficient for extraction. No SDs reported. Paper reports significance as P < 0.1.
Data for control group reported in line graphs only.

Metera 1975b

CCT; 2 groups (non‐parallel), intervention group was cross‐over (2 types of music played in same order for all participants), control group may have been recruited post‐hoc (UNCLEAR).
Allocation method: Participants appear to have been recruited to intervention group first, and control participants recruited after‐ UNCLEAR.
Blinding of group allocation: NOT DONE
Blinded assessment of outcomes: UNCLEAR if automated;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: UNCLEAR;
Protection against contamination: NOT DONE‐ cross‐over in music group. DONE for control group.
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 45 patients with disease of the lungs or chest being treated at the Department of Chest Surgery in Zakopane, Poland.
NUMBERS: Music group = 30, Control group = 15.
AGE, mean: Music group = 34 years old, Control group not described.
GENDER (male/female): Music group = 25/5, Control group not described.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: Cross‐over study. Music was played via headphones. Patients were played Debussy's 3rd part of Bergamasque Suite (Clair de Lune) on the piano (soothing music), and then Bartok's finale of the Wonderful Mandarin (nerve racking/exciting music). First there was a 3‐minute rest in the recumbent position, then a 3‐minute pause before the first musical piece. After the first piece of music, there was a 4‐minute pause before the second musical piece was played.
CONTROL GROUP: Received no music.
No specific treatment/surgery was being given to the patients during the experiment.

Parameters of airway resistance were measured at three time points in both groups: 1) Following 3‐min rest; 2) Following relaxing music; 3) Following exciting music.

AIRWAY RESISTANCE:
Tests were carried out using a Godart Pulmotest. The maximum forced one‐second expiration curve, maximum mid‐expiratory flow rate, first phase of forced expiratory volume, and the inspiration/expiration time ratio, were analysed.

There were no significant differences between the control and music group.

There were no significant differences between conditions within the music group.

Data not sufficient for extraction.

Appears to be same participants in Metera 1975a (mean age and gender distribution of music group is the same).

Mok 2003

CCT; 2 parallel groups;
Allocated by alternation (weeks)
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: Physiological outcomes (DONE‐ automated), C‐STAI (NOT DONE);
Unit of allocation same as unit of analysis: NOT DONE;
Power calculation: DONE;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: DONE;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 80 patients undergoing minor surgery in a day‐surgery ward in China.
NUMBERS: 40 patients per group.
AGE, range: 18‐70.
GENDER, (male/female): Music group = 7/33, Control group = 8/32.
ETHNICITY: not described.
INCLUSION CRITERIA: 18 years or older; consenting; comprehend written and oral instruction.
EXCLUSION CRITERIA: hearing impairment; received preoperative sedative; cardiac disease; history of hypertension.

MUSIC GROUP: Choice of 3 types of music with slow rhythms: classical music (concertos and sonatas), contemporary popular music (e.g. "The heart will go on"), Chinese popular music (e.g. "Night plane"). Music had 45 minutes running time and played via headphones for duration of surgery.
CONTROL GROUP: Standard care.

ANXIETY: measured via C‐STAI post‐surgery. Patients were asked to fill out the questionnaire by thinking retrospectively over procedure.
Mean difference = ‐25.40, 95% CI = ‐29.28, ‐21.52
Music group = 31.83 (4.97)
Control group = 57.23 (11.50)

PHYSIOLOGICAL MEASURES: HR and BP measured via an automated portable HR monitor. Music group had 3 intra‐operative readings taken and the paper reports the mean scores, the control group readings taken post‐operatively only. Data not suitable for comparison.

Moss 1987

CCT; 2 parallel groups;
Allocation method UNCLEAR ("groups were divided by gender and chosen by convenience");
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: DONE;
Power calculation: NOT DONE;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: DONE;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 17 day‐patients undergoing arthroscopic surgery, USA.
NUMBERS: Music group = 9, Control group = 8 patients.
AGE: 20‐40 years old.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: admitted for scheduled arthroscopic surgery under general anaesthesia.
EXCLUSION CRITERIA: none stated.

MUSIC GROUP: Choice of 4 musical tapes (classical tapes from 'Music Rx', Bonny; popular tapes from 'Music Rx'; New Age tape by Steven Halpern called "Dawn"; easy listening selections assembled by investigator). Music played via headset and auto‐reverse cassette player. From administration of pre‐operative medication to PACU. Participants were told to restart the music if they desired after their return to the ambulatory surgery unit.
CONTROL GROUP: standard care.

ANXIETY: state anxiety measured via STAI approximately 2 hours post‐operatively. Non‐significant.
Music group = 32.60 (8.73)
Control group = 29.80 (8.73)

SDs are estimated from the t‐value.

Schuster 1985

CCT; 2 parallel groups;
Allocation method: UNCLEAR;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: UNCLEAR if data collection procedure automated.
Unit of allocation same as unit of analysis: UNCLEAR;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: NOT DONE: BP.
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 63 patients undergoing dialysis, Florida, USA.
NUMBERS: Music group = 31, Control group = 32.
AGE (range): 22‐81 years old.
GENDER (male/female): 24/39.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: Choice of classical, pop, rock, jazz, country/western, gospel, easy listening, swing, and bluegrass played via headphones during dialysis treatment. Music was played for 1 hour beginning 30 minutes after the onset of dialysis treatment, there then was an hour of no music, followed by another hour of music.
CONTROL GROUP: Standard care.

BP: Measured after each hour of dialysis treatment. BP was recorded daily from each patient's chart for a 2‐week baseline period and a 3‐week treatment period. The two groups did not significantly differ on systolic and diastolic BP readings for onset through final readings during the treatment period.
NURSE RATINGS: Not validated.
ATTITUDE SURVEY: Not validated.

Data not sufficient for extraction.

Staricoff 2003b

CCT; 2 parallel groups;
Allocation method: UNCLEAR;
Blinding of group allocation: UNCLEAR (this is one of a series of studies. It states at beginning of document that blinding was carried out where possible but unclear where or how this was achieved).
Blinded assessment of outcomes: UNCLEAR;
Unit of allocation same as unit analysis: UNCLEAR;
Power calculation: NOT DONE;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: UNCLEAR;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 88 pregnant women attending a high‐risk antenatal clinic, London, UK.
NUMBERS: Music group = 54, Control group = 34.
AGE: not described.
GENDER: 100% female.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

MUSIC GROUP: One or two musicians playing in one corner of the waiting room with the chairs arranged in a semi‐circle around them. Harp, clarinet, or guitar were preferred, violin and cello not welcomed. Does not explain in depth what was played.
CONTROL GROUP: No live music.

BP: Obtained by the clinician (method unclear) at the beginning of the consultation (after the waiting room experience). There was no significant difference between the groups.
Systolic BP:
Live music (n = 54), mean (SD) = 115 (13)
Control group (n = 34) mean (SD) = 118 (16)
Diastolic BP:
Live music = 70 (11)
Control group = 72 (11)

This is one of a series of studies. Two more studies were conducted in the antenatal clinic that do not need inclusion criteria for the review due to the study design (before and after).

Szeto 1999

CCT; 2 parallel groups;
Allocation method UNCLEAR ("a quasi‐experimental design was used");
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: DONE;
Power calculation: NOT DONE;
Outcomes obtained for > 80% of participants: NOT DONE;
Groups similar at baseline: DONE;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: DONE (3 control participants could not compete procedure as sent for their operation).

DESCRIPTION: 9 in‐patients waiting for elective surgery in a theatre holding area, China.
NUMBERS: Music group = 6, Control group = 3.
AGE, mean (range): 58 (21‐89).
GENDER: not described.
ETHNICITY: 100% Chinese
INCLUSION CRITERIA: 18 years or older; understand written and verbal instructions; no hearing impairment; not received any pre‐medication sedation; consented to participate.
EXCLUSION CRITERIA: none described.

MUSIC GROUP: Choice of: slow rhythmical songs; Chinese slow rhythmical music; Western slow rhythmical music. Played via headphones for 20 minutes pre‐operatively.
CONTROL GROUP: Standard care.

BP: Measured via a calibrated Dinamap BP monitor before and after 20 minute study period. No significant differences between groups.
Music group (N = 6): Systolic BP = 143.83 (31.25), Diastolic BP = 80.83 (9.07).
Control group (N = 3): Systolic BP = 144.00 (16.09), Diastolic BP = 75.33 (7.02).
ANXIETY: Measured via C‐STAI pre‐ and post‐treatment. Paper reports a significant difference (Wilcoxon Signed‐Rank test) in favour of the music group after the 20 minute study period.
Music group (N = 6) = 33.33 (6.38)
Control group (N = 3) = 46.33 (4.73)
TENSION: Measured via the Subjective Unit of Tension Scale (a NRS) pre‐ and post‐treatment. No significant differences between groups.
Music group (N=6) = 1.67 (1.63)
Control group (N=3) = 3.00 (2.00)

Tanabe 2001

CCT; 3 parallel groups;
Allocation method: alternation;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: DONE;
Power calculation: DONE;
Outcomes obtained for > 80% of participants: DONE;
Groups similar at baseline: Pain‐ DONE, demographics‐ UNCLEAR;
Protection against contamination: NOT DONE;
Description of withdrawals and drop‐outs: DONE (75 exclusions detailed).

DESCRIPTION: 76 patients presenting to an emergency department with minor musculoskeletal trauma, in Midwest USA.
NUMBERS: Music group = 24, Standard Care = 28, Ibuprofen = 24 (excluded from review).
AGE mean (SD): 41 (17.54) years old.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: 18 years or older; chief complaint of minor extremity trauma distal to and including the knee or elbow.
EXCLUSION CRITERIA: analgesics administered prior to arrival; injury occurred more than 24 hours earlier; pain rating 3 or less; unable to speak English; unable to use pain scales; lacerations; sensitivity to cold; Raynaud's phenomenon; rheumatoid arthritis to the affected joint.

MUSIC GROUP: Provided with a Walkman tape player and choice of music (classical, country, rock, pop, and jazz), or were allowed to listen to the radio if they preferred. Patients also received standard care.
STANDARD CARE: Consisted of ide, elevation, and immobilization of the affected extremity.
IBUPROFEN: Excluded from review.

PAIN: Pain intensity measured at 0, 30, and 60 minutes via 10‐point NRS. There was no statistical differences between groups at any time interval. All groups showed significant improvement from baseline.
Mean pain ratings:
Music group: 0 min = 6.46; 30 min = 5.75; 60 min = 5.83
Standard care: 0 min = 6.57, 30 min = 5.61; 60 min = 5.57

SATISFACTION: Measured via VRS and a non‐validated yes/no question. There were no differences between groups on either measure.

No SDs provided.

Tse 2005

CCT; 2 parallel groups;
Allocation method: Mondays = experimental group, Thursdays = control group.
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: NOT DONE;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: DONE;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 57 post‐operative in‐patients who have undergone elective nasal surgery.
NUMBERS: Music group = 27, Control group = 30.
AGE, mean (SD): Music group = 39.2 (14.4), Control group = 40.6 (14.5).
GENDER (male/female): Music group = 11/16, Control group = 13/17.
ETHNICITY: 100% Chinese.
INCLUSION CRITERIA: scheduled for functional endoscopic sinus surgery or turbinectomy.
EXCLUSION CRITERIA: History of mental disturbance; had undergone previous major surgery; opioid dependent; hearing problem; history of hypertension.

MUSIC GROUP: Choice of Chinese and Western various music types and patients encouraged to bring music of their own choice. Listened for 30 minutes on four occasions: post‐operatively (T1), again 4 hours later (T2), on the first post‐operative day at 8am (T3) and again at noon (T4).
CONTROL GROUP: Standard care.

PAIN: Measured via VRS at baseline and after each intervention session. Music group gave significantly lower pain ratings at all four time points. T4 data:
Music group = 1.04 (0.28)
Control group = 4.07 (0.33).
SYSTOLIC BP: Measurement method unclear. Significant differences at all four time points in favour of music group. T4 data:
Music group = 113.67 (11.28) mm Hg
Control group = 132.37 (18.68) mm Hg
HR: Measurement method unclear. Significant differences at all four time points in favour of music group. T4 data:
Music group = 74.52 (5.99) bpm
Control group = 81.57 (7.61) bpm
PAIN MEDICATION: Number of paracetamol tablets taken, and dose of diclofenac sodium was recorded four hours after surgery and at 8am on the first post‐operative day. Significant differences were found in favour of the music group at both time points for paracetamol intake, and at the first time point only for diclofenac sodium intake. 8am on first post‐operative day data:
Music group: Paracetamol intake = 2.15 (2.41) tablets, Diclofenac Sodium = 0.04 (0.19).
Control group: Paracetamol intake = 5.43 (2.00), Diclofenac Sodium = 0.20 (0.41).

Williamson 1992

CCT; 2 parallel groups;
Method of allocation: alternation;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: DONE;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: demographics‐ DONE;
Protection against contamination: DONE;
Description of withdrawals and dropouts: DONE (4 patients refused to listen to ocean sounds after first night).

DESCRIPTION: 60 post‐operative in‐patients after coronary artery bypass graft in a progressive care area, USA.
NUMBERS: 30 patients per group.
AGE, mean (SD): Sounds = 58.6 (7.72), Control group = 58.3 (9.31) years old.
GENDER (male/female): Sounds = 21/9, Control group = 24/6.
ETHNICITY: not described.
INCLUSION CRITERIA: presenting for elective coronary artery bypass graft surgery; 21‐69 years old; were not retained in the ICU for longer than 3 days after surgery; did not have to return to surgery; were not placed on the intra‐aortic balloon pump; did not receive any surgery other than bypass grafting.
EXCLUSION CRITERIA: Documented sleep disorder; were having repeat coronary artery bypass graft surgery; taking tricyclic antidepressants regularly within 1 month of surgery; could not hear sounds played softly at bedside; experimental group participants did not complete 3 nights of listening to ocean sounds; chest pleural tube in place beyond the 2nd night post‐transfer to progressive care unit.

SOUNDS GROUP: Marsona Sound Conditioner (providing white noise in the form of rain, ocean waves, or a waterfall). 56/60 patients chose ocean sounds. Sounds were played at the bedside throughout the night (switched on between 20.30 and 21.00 hours). Sounds played for 3 nights.
CONTROL GROUP: No sounds.

SLEEP: Pre‐test evaluated for patients on their usual sleep at home, data collected on admission, prior to surgery. Assessed on the fourth day post‐transfer for the quality of sleep the previous night. Measured via the Richards‐Campbell Sleep Questionnaire, which includes VAS for sleep depth, latency to sleep onset, awakening, return to sleep, quality of sleep, and a total sleep score. No SDs reported.
The sound group reported significantly deeper sleep than controls:
Sound group: Pre‐test = 49, Post‐test = 56
Control group: Pre‐test = 66, Post‐test = 35
There was no significant difference between groups in falling asleep:
Sound group: Pre‐test = 68, Post‐test = 71
Control group: Pre‐test = 62, Post‐test = 60
The sounds group reported being awake significantly less in the night:
Sound group: Pre‐test = 68, Post‐test = 65
Control group: Pre‐test = 69, Post‐test = 51
The sounds group returned to sleep significantly faster than controls:
Sound group: Pre‐test = 63, Post‐test = 68
Control group: Pre‐test = 61, Post‐test = 51
The sounds group reported significantly better quality of sleep than controls:
Sounds group: Pre‐test = 71, Post‐test = 69
Control group: Pre‐test = 67, Post‐test = 46
The total sleep score was significantly better in the sound group:
Sounds group: Pre‐test = 64, Post‐test = 66
Control group: Pre‐test = 65, Post‐test = 48

Wolowicka 1989

CCT; 2 parallel groups;
Allocation method: UNCLEAR;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: UNCLEAR;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: UNCLEAR;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 50 patients undergoing surgery with local anaesthetic, Poland.
NUMBERS: Music group = 30, Control group = 20.
AGE: not described.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: none described.
EXCLUSION CRITERIA: none described.

MUSIC GROUP: Played music before during and after surgery. Patients chose music from a selection of instrumental tapes (music was soft, bright, avoiding high‐pitched sounds, classical).
CONTROL GROUP: Standard care.

ANXIETY: Measured via STAI the day before and directly after surgery in the recovery room.
Music group: pre‐surgery = 38, post‐surgery = 36.
Control group: pre‐surgery = 46, post‐surgery = 43.
On the second and third day after surgery anxiety was lower in the music group. No statistical analyses reported.

Data not in sufficient detail for extraction.

Yamanaka 2003

CCT; 2 parallel groups;
Allocation method: Day of week;
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: NOT DONE;
Unit of allocation same as unit of analysis: NOT DONE;
Power calculation: UNCLEAR;
Outcomes obtained for > 80% of participants: UNCLEAR;
Groups similar at baseline: UNCLEAR;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: NOT DONE.

DESCRIPTION: 57 in‐patients undergoing surgery with local anaesthetic, Japan.
NUMBER: Music group = 34, Control group = 23.
AGE, mean (range): Music group = 45.3 (18‐75), Control group = 38.2 (15‐79) years old.
GENDER (male/female): Music group = 12/22, Control group = 6/17.
ETHNICITY: not described.
INCLUSION CRITERIA: Consenting participants during the period May to July.
EXCLUSION CRITERIA: none described.

MUSIC GROUP: Were played a set piece (by Elgar) from when they entered the theatre to the end of surgery.
CONTROL GROUP: Standard care.

ANXIETY: Measured via STAI before and after surgery. Participants were requested to think back to how they felt during surgery in the post‐treatment questionnaire.

Authors group findings into those who demonstrated a reduction in anxiety (from pre to post), those who showed no change, and those who showed an increase in anxiety. They then used Chi‐square to assess the differences between music and control groups. This analysis showed no difference between groups.

Yung 2002

CCT; 3 parallel groups;
Allocation method: UNCLEAR, paper states it was a quasi‐experimental design.
Blinding of group allocation: NOT DONE;
Blinded assessment of outcomes: Anxiety‐ NOT DONE, BP and HR‐ automated;
Unit of allocation same as unit of analysis: DONE;
Power calculation: NOT DONE;
Outcomes obtained for > 80% of participants: DONE;
Groups similar at baseline: DONE;
Protection against contamination: DONE;
Description of withdrawals and drop‐outs: DONE (description of 12 exclusions and no withdrawals).

DESCRIPTION: 30 pre‐operative patients waiting for transurethral resection of the prostate, in a theatre holding area, Hong Kong, China.
NUMBERS: 10 patients in each group.
AGE, mean (SD): Music group = 65.2 (10.15), Control group = 70.9 (6.49).
GENDER: 100% male.
ETHNICITY: 100% Chinese.
INCLUSION CRITERIA: Comprehend oral and written instructions.
EXCLUSION CRITERIA: Cardiac disease; history of hypertension; received pre‐operative sedation.

MUSIC GROUP: 20 minutes of slow rhythm soft music played pre‐operatively via headphones. Choice of three tapes that had been judged by a panel of 3 musicians (slow rhythm songs, Chinese slow rhythm music, Western slow rhythm music). No nurse presence.
CONTROL GROUP: No nurse or music present.
NURSE PRESENCE: Excluded from review.

PHYSIOLOGICAL: BP and HR recorded on an automated BP monitor (Dinamap 1846‐SX) before and after 20 minute study period. Paper reports no significant differences between groups (Kruskal‐Wallis test)
BP:
Music group: Systolic BP = 126.5 (18.03), Diastolic BP = 73.9 (10.83)
Control group: Systolic BP = 138.8 (19.61), Diastolic BP = 81.0 (10.71)
HR:
Music group = 72.2 (12.32)
Control group = 79.3 (11.26)
ANXIETY: Measured via the C‐STAI before and after 20 minute study period. Paper reports no significant differences between groups (Kruskal‐Wallis test):
Music group = 37.6 (7.41)
Control group = 37.7 (7.27)

BP: blood pressure; HR: heart rate; RR: respiration rate; STAI: State Trait Anxiety Inventory; VAS: visual analogue scale

Figures and Tables -
Table 9. Music [CCT]: Characteristics of post‐hoc exclusions (non‐randomised studies)
Table 10. Music [A‐M]: Characteristics of excluded studies

Study ID

Reason for exclusion

Abramson 1966

No data presented‐ summary paper

Bampton 1997

Validity of outcomes

Beck 1991

Setting

Boeke 1988

Validity of outcomes

Bonke 1982

Outcomes not reported for relevant groups; data collection methods unclear.

Bozcuk 2006

Study design

Browning 2001

Intervention provided outside of hospital

Byers 1997

Study design

Bykov 2003b

Setting and population

Cai 2001a

Intervention

Cai 2001b

Intervention

Ceccio 1984

Intervention‐ relaxation technique

Chikamori 2004

Intervention

Clair 1994

Questionable validity of outcome, relevant data not presented

Clair 2006

Setting

Clark 1998

Setting

Cooper 1991

Qualitative report

Courtright 1990

Outcome measure

Cunningham 1997

Outcomes

Davis 1992

Setting

De l'Etoile 2002

Intervention

Denney 1997

Setting

Dritsas 2004

Intervention not well defined

Durham 1986

Intervention provided during education programme

Eisenman 1995

Study design

Escher 1993

Music therapist confound; group differences in timing of data collection

Fauerbach 2002

Intervention included coaching of participants

Ferguson 1997

Setting not hospital

Fox 1986

Study design

Frank 1985

Study design

Fratianne 2001

Intervention interactive music therapy

Frid 1981

Interventions not suitable for inclusion

Good 1995

Invention group provided 20mins coaching.

Good 1998

Intervention group provided reinforcement and training‐ bias

Good 1999

Intervention group provided coaching on relaxing

Good 2001

Secondary analysis of previous study

Good 2002

Secondary analysis of previous study

Good 2005

Secondary analysis of previous study

Götell 2002

Setting; qualitative

Götell 2003

Qualitative

Guzzetta 1989

Relaxation (psychological) technique use with intervention

Harris 1992

Outcomes not health‐related

Haythornthwaite 2001

Intervention‐ taught techniques

Helmes 2006

Outcomes

Hooper 1992

Case study

Hsu 1998

Intervention not well defined

Huffman 1994

Intervention not well defined

Janelli 1997

Policy confound (restraints use)

Janelli 1998

Policy confound (restraints use)

Janelli 2000

Policy confound (restraints use)

Janelli 2002

Outcome measure

Janelli 2004

Outcome measure

Janiszewski 1980

Study design

Jarvis 1979

Conference abstract‐ not enough detail

Jonas 1988

Study design

Kaiming 1997

Intervention not well defined

Kane 2004

Data unsuitable for cross‐over study

Kim 2005

Setting

Kimata 2003

Setting

Kopp 1991

Intervention not well defined

Kumar 1992

Validity of outcomes

Kwon 2006

Study design‐ selection of participants by matching, different wards assigned to different conditions.

Lai 1999

Unable to clarify discrepancies in data with author

Lai 2005

Setting

Lai 2006

Setting; Duplicate

Laurion 2003

Intervention began before admission

Lazaroff 2000

Unclear methods and data

Leão 2004

Study design

Locsin 1979

Intervention not well described (CCT)

Locsin 1981

Intervention not well described (CCT)

McCaffrey 2004

Outcomes not validated/reliable

Mellgren 1967

Study design

Mihara 2005

Lack of information

Miluk‐Kolasa 1994

Confounding

Miluk‐Kolasa 1996

Intervention not well described

Miluk‐Kolasa 2002

Intervention not well described

Moss 1988

Intervention not well described, no data presented (CCT)

Murrock 2002

Setting

Figures and Tables -
Table 10. Music [A‐M]: Characteristics of excluded studies
Table 11. Music [N‐Z]: Characteristics of excluded studies

Study ID

Reason for exclusion

Norberg 1986

Study design

Prensner 2001

Study design

Ragneskog 1996

Setting

Rakshy 1997

Inappropriate methods and analysis

Routhieaux 1997

Outcomes not patient‐related

Salmore 2000

Intervention

Sármány 2006

Patients allocated retrospectively to music or control, depending on whether or not they had noticed or heard any music playing (unpublished information).

Satoh 1983

Intervention not well described

Schuhl 1985

Data collection tool not validated

Sherratt 2004

Outcomes not validated

Shertzer 2001

Policy change‐ staff asked to remain quiet on intervention days

Sidorenko 2000a

Therapy as treatment

Siedliecki 2006

Setting

Spintge 2000

Overview‐ insufficient detail

Spitzer 2005

Music not well described; cross‐over trial with and with‐out vibration

Standley 1992

Setting

Staricoff 2003a

Study design

Staricoff 2003c

Study design

Staricoff 2003d

Study design

Staricoff 2003e

Study design

Steelman 1990

Intervention not well defined

Stermer 1998

Outcomes not validated

Stone 1989

Study design

Strauser 1997

Setting

Swinford 1987

Intervention

Thorgaard 2004

Outcomes not validated

Thorgaard 2005

Study design

Tierney 1978

Study design; outcomes

Uedo 2004

Insufficient information (intervention and data)

Updike 1987

Study design

Updike 1990

Study design

Vollert 2002

Test (not clinical) situation, healthy controls

Vollert 2003

Setting

Walther‐Larsen 1988

Intervention not well defined; validity of outcomes unclear

Yilmaz 2003

Inappropriate control‐ drugs

Zhong 2005

Duplicate study (Lee 2005)

Figures and Tables -
Table 11. Music [N‐Z]: Characteristics of excluded studies
Table 12. Other outcomes: Music versus blank tape/headphones only

Outcome

Detailed RCTs (N)

Participants (N)

Heterogeneity (%)

Results

Other RCTs

Participants (N)

Findings

Oxygen saturation

N = 1
Nilsson 2005

Total = 50
Music = 25
Control = 25

N/A

MD 1.60, 95% CI 0.05 to 3.15, P value = 0.04
In favour of music.

N = 1
Chlan 1995

Total = 20
Music = 11
Control = 9

No significant difference between groups.

Airway pressure

None

N/A

N/A

N/A

N = 1
Chlan 1995

Total = 20
Music = 11
Control = 9

No significant differences between groups.

Skin conductance

N = 2
Wang 2002;
Guo 2005

Total = 186
Music = 96
Control = 90

I2 = 81.7% (one study significant, one study non‐significant)

SMD 0.13, 95% CI −0.55 to 0.80, P value = 0.71 (Analysis 3.5).

None

N/A

N/A

Heart rate variability (RR intervals, low and high frequency bands, total power, low/high frequency ratio)

None

N/A

N/A

N/A

N = 1
Chui 2003

Total = 68
Music = 34
Control = 34

Heart rate variability data (high frequency power, logarithm of low frequency, and high/low frequency ratio) showed significant positive changes in the music group but not control group. Other variables (RR intervals, low and high frequency bands, low frequency power, and logarithm of high frequency) were non‐significant.

Bispectral index (mean, time to reach BIS 60)

N = 2
Ganidagli 2005;
Zhang 2005

Total = 160
Music = 80
Control = 80

N/A (studies reported different outcomes)

Bispectral index: MD 1.00, 95% CI −1.27 to 3.27, P value = 0.39;
Time to reach BIS 60: MD −5.00, 95% CI −15.55 to 5.55, P value = 0.35

None

N/A

N/A

Stress hormones (Cortisol, epinephrine, norepinephrine, adrenocorticotropic hormone‐ ACTH)

N = 3
Migneault 2004;
Wang 2002;
Guo 2005

Total = 216
Music = 111
Control = 105

Cortisol I2 = 51.8% (3 studies)
Others I2 = 0% (2 studies)
ACTH, N/A (1 study)

Cortisol: SMD −0.32, 95% CI 0.73 to 0.09, P value = 0.13;
Epinephrine: SMD −0.02, 95% CI −0.38 to 0.33, P value = 0.91;
Norepinephrine: SMD −0.08, 95% CI −0.44 to 0.27, P value = 0.64;
ACTH: SMD −0.44, 95% CI −1.17 to 0.28, P value = 0.23

(Analysis 3.6)

N = 1
Nilsson 2005

Total = 75
Intra‐operative music = 25
Post‐operative music = 25
Control = 25

No differences in cortisol levels at any time between groups. Change scores at 2 hours post‐operatively were significantly greater in the post‐operative music group than control. Blood glucose levels did not differ between groups at any time.

Mood

N = 1
Chlan 1995

Total = 20
Music = 11
Control = 9

N/A

MD −8.50, 95% CI −18.55 to 1.55, P value = 0.10

None

N/A

N/A

Abnormal events (hypoxaemia, hypotension, hypertension, bradycardia, tachycardia, respiratory depression, pruritis)

N = 1
Andrada 2004

Total = 118
Music = 63
Control = 55

N/A

Cardio‐respiratory incidents = 0;
Oxygen desaturation = 0;
Arterial hypertension = 1 control;
Arterial hypotension = 2 control;
Bradycardia = 3 music, 2 control;
Tachycardia = 1 music, 1 control.

N = 1
Cepeda 1998

Total = 193
Music = 97
Control = 96

Vomiting (Intra‐operatively/PACU): Music = 0/0%, Control = 2.2/0%
Pruritus (Intra‐operatively/PACU): Music = 26.6/27.6%, Control = 26.1/26.1%
Bradycardia (intra‐operatively/PACU): Music = 0/0%, Control = 2.3/0%

Unclear missing data as presented in % values.

Headache

N = 1
Nilsson 2003b

Total = 115
Music = 59
Control = 56

N/A

MD 0.00, 95% CI −0.15 to 0.15, P value = 1.00

None

N/A

N/A

Fatigue

N = 1
Nilsson 2003b

Total = 115
Music = 59
Control = 56

N/A

MD −0.30, 95% CI −0.78 to 0.18, P value 0.22

N = 1
Nilsson 2003a

Total = 151
Intra‐operative music = 51
Post‐operative music = 51
Control = 49

There were no significant differences between groups.

Urinary problems

N = 1
Nilsson 2003b

Total = 115
Music = 59
Control = 56

N/A

MD −0.10, 95% CI −0.40 to 0.20, P value = 0.51

None

N/A

N/A

Well‐being

N = 1
Nilsson 2003b

Total = 115
Music = 59
Control = 56

N/A

MD 0.30, 95% CI 0.02 to 0.58, P value = 0.03 in favour of music group.

None

N/A

N/A

Nausea

N = 2
Nilsson 2003b;
Cepeda 1998

Total = 308
Music = 156
Control = 152

N/A (different methods of measurement)

MD −0.20, 95% CI −0.50 to 0.10, P value = 0.19

OR 0.82, 95% CI 0.35 to 1.93, P value = 0.64

N = 1
Nilsson 2003a

Total = 151
Intra‐operative music = 51
Post‐operative music = 51
Control = 49

There were no significant differences between groups.

Satisfaction

N = 1
Zhang 2005

Total = 110
Music = 55
Control = 55

N/A

MD 1.60, 95% CI 1.29 to 1.91, P value < 0.00001
in favour of music group

N = 2
Cepeda 1998;
Nilsson 2003a

Total = 344
Intra‐operative music = 148
Post‐operative music = 51
Control = 145

There were no significant differences between groups.

Length of stay

N = 1
Blankfield 1995

Total = 61
Music = 32
Control = 29

N/A

MD 0.00, 95% CI −0.99 to 0.99, P value = 1.00

N = 2
Harikumar 2006;
Heitz 1992

Total = 118
Music = 58
Control= 60

Harikumar 2006 reports that recovery time was significantly longer (difference in medians = 10 minutes) in the control group. Heitz 1992 reports no significant differences between groups.

Activities of daily living

N = 1
Blankfield 1995

Total = 61
Music = 32
Control = 29

N/A

MD −0.30, 95% CI −2.63 to 2.03, P value 0.80

None

N/A

N/A

Serum interleukins (IL‐6)

N = 1
Zhang 2005

Total = 110
Music = 55
Control = 55

N/A

MD −7.40, 95% CI −22.61 to 7.81, P value = 0.34

None

N/A

N/A

Induction time of sedation (minutes)

N = 1
Zhang 2005

Total 110
Music = 55
Control = 55

N/A

MD −6.00, 95% CI −10.49 to −1.51, P value = 0.009 in favour of music.

None

N/A

N/A

CI: confidence interval; MD: mean difference; SMD: standardised mean difference; PACU: post‐operative care unit; RR: respiration rate

Figures and Tables -
Table 12. Other outcomes: Music versus blank tape/headphones only
Table 13. Other outcomes: Music versus Standard Care

Outcome

Detailed RCTs (N)

Participants (N)

Heterogeneity (%)

Results

Other RCTs

Participants (N)

Findings

Comments

Skin temperature

N = 4
Cadigan 2001;
Chang 2005;
Masuda 2005;
Zimmerman 1988.

Total = 298
Music = 144
Control = 154

I2 = 0%

SMD 0.15, 95% CI −0.08 to 0.37, P value = 0.21;
No difference between groups. (Analysis 5.6)

None

N/A

N/A

Oxygen saturation

N = 3
Chan 2006;
Chang 2005;
Koch 1998b.

Total = 150
Music = 73
Control = 77

I2 = 79%;
1 significant study and 2 non‐significant studies.

MD −0.71%
95% CI −1.75 to 0.32, P value =
0.17;
No difference between groups. (Analysis 5.7)

None

N/A

N/A

Requirement for oxygen supplementation

N = 1
Schiemann 2002

Total = 119
Music = 59
Control = 60

N/A

OR 0.49,
95% CI 0.09 to 2.79, P value
= 0.42;
No difference between groups.

None

N/A

N/A

Blood flow characteristics

N = 1
Masuda 2005

Total = 44
Music = 22
Control = 22

N/A

Blood flow: MD −2.40 ml/min/100g, 95% CI −7.45 to 2.65, P value = 0.35;
Blood mass: MD 3.90 (relative value), 95% CI −4.67 to 12.47, P value = 0.37;
Blood velocity: MD 0.29 KHz, 95% CI −0.11 to 0.69, P value = 0.15;
No difference between groups.

None

N/A

N/A

Bispectral index

N = 1
Yang 2003

Total = 39
Music = 19
Control = 20

N/A

MD 0.22 BIS value,
95% CI −0.76 to 1.20, P value =
0.66;
No significant difference between groups.

None

N/A

N/A

It is unclear if this study meets the review inclusion criteria. Music group may have received intervention prior to coming to hospital.

Lung Function: (dyspnoea, tidal volume, minute ventilation, oxygen consumption, airway resistance).

None

N/A

N/A

N/A

N = 1
Nowobilski 2005

Total = 36
Music = 18
Control = 18

No significant differences.

Stress hormones (Cortisol, Prolactin).

N = 1
McRee 2003

Total = 26
Music = 13
Control = 13

N/A

Cortisol: MD 7.29, 95% CI −7.37 to 21.95, P value = 0.33;
Prolactin: MD −2.50, 95% CI −33.58 to 28.58, P value = 0.87;
No difference between groups.

N = 1
Schneider 2001

Total = 30
Music = 15
Control = 15

Cortisol significantly increased in the control group and remained unchanged in the music group. Catecholamines were non‐significant.

Mood

N = 2
Taylor‐Piliae 2002;
Cadigan 2001.

Total = 170
Music = 80
Control = 90

I2 = 0%

MD −1.18,
95% CI −2.17 to −0.19, P value = 0.02 in favour of music group. (Analysis 5.8)

None

N/A

N/A

Anger

N = 1
Lembo 1998

Total = 24
Music = 12
Control = 12

N/A

MD −1.80,
95% CI −2.26 to −1.34, P value < 0.00001 in favour of music group.

None

N/A

N/A

Depression

N = 1
Yang 2003

Total = 39
Music = 19
Control = 20

N/A

MD −3.29,
95% CI −4.99 to −1.59, P value =
0.0001 in favour of music group.

None

N/A

N/A

It is unclear if this study meets the review inclusion criteria. Music group may have received intervention prior to coming to hospital.

Fatigue

None

N/A

N/A

N/A

N= 1
Lembo 1998

Total = 24
Music = 12
Control = 12

No significant difference between groups.

Uncertainty

N = 1
Taylor‐Piliae 2002

Total = 30
Music = 15
Control = 15

N/A

MD −3.53, 95% CI −12.15 to 5.09, P value =
0.42; No difference between groups.

None

N/A

N/A

Satisfaction

N = 2
Lee 2002;
Chlan 2000.

Total = 174
Music = 85
Control = 89

I2 = 0%

MD 0.46, 95% CI 0.16 to 0.76,
P value = 0.003 in favour of music (Analysis 5.9).

None

N/A

N/A

Nausea

None

N/A

N/A

N/A

N = 1
Ezzone 1998

Total = 33
Music = 16
Control = 17

The paper reports that the music group had significantly less nausea and vomiting than the control group (Mann‐Whitney U test, P < 0.017).

Length of stay

N = 2
Koch 1998a;
Schiemann 2002.

Total = 153
Music = 78
Control = 75

I2 = 0%

MD −6.00 minutes, 95% CI −10.72 to −1.28, P value = 0.01 in favour of music group (Analysis 5.10).

N = 1
Heitz 1992

Total = 60
Music = 20
Standard care = 20
Headphones only = 20

Findings were non‐significant.

Intubation time

N = 1
Twiss 2006

Total = 60
Music = 28
Control = 32

N/A

MD −200.20 minutes, 95% CI −391.03 to −9.37, P value = 0.04 in favour of music group.

None

N/A

N/A

CI: confidence interval; MD: mean difference; SMD: standardised mean difference

Figures and Tables -
Table 13. Other outcomes: Music versus Standard Care
Table 14. Access to nature: Characteristics of excluded studies

Study ID

Reason for exclusion

DeSchriver 1990

Setting

Morsley 1999

Commentary

Rice 1980

Outcomes

Siegman‐Igra 1986

Study design

Ulrich 1984

Study design‐ retrospective matched pairs

Figures and Tables -
Table 14. Access to nature: Characteristics of excluded studies
Table 15. Air quality: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Notes

Engelhart 2003

CCT; 2 parallel groups.

DESCRIPTION: In‐patients, predominantly with leukaemia, multiple myeloma, and malignant non‐Hodgkins lymphoma, admitted to the haematology‐oncology unit in Bonn, Germany.
NUMBERS: Over one year there was 4800 bed days in the control group, and 1200 bed days in the air filtration group.
GENDER: not described.
AGE: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

AIR FILTRATION: 3 rooms (single or double) were fitted with portable air filtration units (NSA model 7100A/B Environment Air System, National Safety Association Ltd., Memphis, USA). These units have a 95% filtering capacity for particles > 0.3 micrometers. They have two settings (high/low). Flow rate: High = 168, Low = 112 cubic m/hr.
Noise: High = 57, Low = 55 dB(A). Patients were advised to keep windows closed as much as possible and run the unit on the high setting.
CONTROL: Standard care, no air filtration units.

All rooms were naturally ventilated with no HEPA filtration. They were on the 1st floor surrounded by forest. Patients instructed to keep windows closed during periods of neutropenia, wear masks when leaving the room, avoid showering, and use sterile water during other applications. Regular policies for aspergillus prevention included daily disinfection of horizontal surfaces, prohibiting potted plants and flower arrangements within the whole unit.

INVASIVE ASPERGILLOSIS: Counts of cases (confirmed and suspected) were achieved via ward liaison, targeted chart reviews, and consultation with medical staff.

One confirmed case, and four suspected cases were recorded (5 per 4800 bed days). All were allocated to control areas. No cases were recorded in rooms with air filtration (0 per 1200 bed days). This difference was not significant (Fisher's Exact, P value = 0.33).

AIR SAMPLING: not a patient outcome.

Compliance to the air filtration units was low; they were generally run on low due to the noise generated, and sometimes stopped during the night.

Lohner 1979

RCT; 2 parallel groups.

DESCRIPTION: 45 inpatients undergoing treatment for acute leukaemia or bone marrow aplasia, in Belgium.
NUMBERS: Isolation group = 24, Control group = 21.
AGE, mean (range): Isolation group = 44.8 (17 to 72), Control group = 46.4 (13 to 74) years old.
GENDER (male/female): Isolation group = 16/8, Control group = 14/7.
ETHNICITY: not described.
INCLUSION CRITERIA: During induction treatment of acute leukaemia or during bone marrow aplasia regardless of its origin. All were treated at the Institut Jules Bordet between May 1973 and April 1977.
EXCLUSION CRITERIA: none described.

ISOLATION: Patients were isolated in a laminar air flow room. The isolation unit consisted of a normal bed enclosed in a plastic tent. The area available for the patient was about 5 sq metres. Air was pumped vertically through high‐efficiency filters positioned on the ceiling. All procedures on the patient were done through plastic gloves on the sides of the tent. All items entering the unit were either gas or steam sterilized, passing through locks irradiated by ultraviolet light. The tent was only opened when absolutely necessary. Any person approaching the isolated patients wore sterile boots, gloves, gown, and mask. Patients remained in isolation until either the bone marrow showed haematologic remission or myeloid proliferation and maturation. The study period ended when the patient was no longer in isolation.
CONTROL: Patients were kept in single rooms during the entire hospitalisation period. Patients left the rooms only for special examinations, such as radiologic or isotopic investigations.

All patients received oral non‐absorbable antibiotics, and sterile food and liquid. Unclear if cleaning protocols of patients were identical for both groups.

BACTERIAL INFECTIONS: Fungal cultures of stools were performed at least once a week. Data is reported as a count of the number of patients in which suppression of bacterial growth from stool cultures was achieved. Cultures were also obtained from the nose, gingiva, throat, ear, and axilla. Results report the number of days with infection (per 1000 days with severe neutropenia).
MORTALITY: A count is provided of the number of fatal infections.
REMISSION: A count is provided of the number of patients in complete and "partial" remission. Data extracted for complete remission.
ADVERSE EVENTS: The paper reports on a number of people removed from isolation due to poor psychologic tolerance.

Whyte 1969

CCT; 2 parallel groups.

DESCRIPTION: 1726 in‐patients residing in the wards of a surgical unit (urological surgery/general surgery), in Scotland, UK.
NUMBERS: Open plan wards = 926, Closed ward = 800.
AGE, average: Open plan wards = 38, Closed ward = 38 years old.
GENDER (male/female): Open plan wards = 417/509, Closed ward = 368/432.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

OPEN WARDS: Two wards (one male, one female) with natural ventilation (and no mechanical ventilation). The male ward had partitioned 4‐6 bedded bays, housing a total of 28 beds, and female ward was completely open plan with 29 beds.
CLOSED WARD: One mixed gender ward divided into rooms (four 5‐bed male rooms, and five 4‐bed female rooms, plus 4 single rooms for either gender as required). This ward was air‐conditioned, with the air filtered, humidified, and heated or cooled. Temperature in the ward area was maintained at 20 degrees celsius and the relative humidity of 55%. Patient rooms had approximately 7‐8 air changes per hour. Two thirds of the ward air was re‐circulated through high‐efficiency filters.

STAPHYLOCOCCUS AUREUS (Staph. aureus): Nasal acquisition of Staph. aureus was monitored via swabs taken on admission, and then every Monday and Thursday thereafter. Data reported as the number of acquisitions, and the rate per 100 patient‐week. The number of tetracycline‐resistant strains of Staph. aureus and delayed acquisitions was also determined.
WOUND SEPSIS: A wound was regarded as infected (1) when pus was visible to the naked eye, or (2) if a fluid exudate was present and pathogenic bacteria were isolated from it.

Figures and Tables -
Table 15. Air quality: Characteristics of included studies
Table 16. Air quality: Characteristics of excluded studies

Study ID

Reason for exclusion

Alberti 2001

Study design

Azer 1971

Setting

Baird 1969

Outcomes

Bodey 1969

Study design (no control)

Bodey 1971

Study design (matched pairs)

Choctaw 1984

Policy confound (sterile versus clean attire)

Chow 2005

Study design (computer modelling)

Dekker 1994

Confounding

Demling 1978

Patients‐ mix of adults and children, data inseparable

Freireich 1975

Preliminary report of Rodriguez 1978; policy confound

Friberg 1999

Sham operations

Friberg 2003

One patient health‐related outcome reported (surgical site infections), but not enough detail on how it was assessed or if it was noted on an 'ad hoc' basis.

Gundermann 1974

Not patient outcomes

Lai 2001

Study design

Legg 1970

Not patient outcomes; test scenario

Lidwell 1969

Not patient outcomes; test scenario

Lidwell 1975

Study design

Lidwell 1982

Some relevant subgroups within study however cannot separate data (number of re‐operations in each subgroup). Additionally, there are discrepancies in reporting with Lidwell 1984 with 185 patients switching subgroups.

Lidwell 1984

Same study as Lidwell 1982. Non‐transparant reporting of findings‐ data not usable. Discrepancies between Lidwell 1982 and Lidwell 1984.

Lowbury 1971

Population‐ age

Lowbury 1978

Preliminary report of Lidwell 1982 and Lidwell 1984

May 1984

Study design

Passweg 1998

Retrospective study; population (age)

Petersen 1987

Policy (decontamination) changes

Qian 2006

Mock setting

Rodriguez 1978

Policy confounding

Schimpff 1975

Policy confounding

Sherertz 1987

Study design

Steingold 1963

Study design

Whyte 1968

Not patient outcomes

Yates 1973

Policy confounding

Figures and Tables -
Table 16. Air quality: Characteristics of excluded studies
Table 17. Bedroom type: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Notes

Lidwell 1971

CCT; 2 parallel groups.

DESCRIPTION: 3327 patient‐weeks were analysed. Participants were in‐patients on one of two medical wards in the UK.
NUMBERS: Open wards = 2750 patient‐weeks, Closed single rooms = 577 patient‐weeks.
AGE: under 60 years = 57%, Over 60 years = 43%.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

OPEN WARD: Two identical wards each containing 6 four‐bed rooms, which opened up on to the corridor. The four‐bed rooms each had three proper walls with the fourth side being open to the corridor except for low dividing walls (3 ft.) on each side of the entrance.
SINGLE‐BED ROOMS: The same two wards as above each had five single rooms, each proper rooms with four walls to divide them from the rest of the ward. There was no mechanical ventilation in these rooms.

PATIENT NASAL AQUISITION OF STAPHYLOCOCCUS AUREUS: A nasal swab was taken from patients as soon as possible after arriving on the ward (within 3 days). Subsequently a swab was taken from each patient on a set day of the week.
STAFF NASAL AQUISITION: Not included in review.
AIR CONTAMINATION: Not included in review.

Ratio of nasal carriage rates in single rooms to 4‐bed bays:
All strains = 1:2
Tetracycline resistant strains = 1:4

Ratio of nasal acquisition rates in single rooms to 4‐bed bays:
All strains = 1:1
Tetracycline resistant strains = 1:3

Figures and Tables -
Table 17. Bedroom type: Characteristics of included studies
Table 18. Bedroom type: Characteristics of excluded studies

Study ID

Reason for exclusion

Armstrong 1984

Review article

Burke 1977

Participants (age)

Chaudhury 2003

Cross‐sectional survey and qualitative interviews

Dekker 1994

Confounding

Dolce 1985

Retrospective study

Duckworth 1988

Policy changes

Freireich 1975

Preliminary report of Rodriguez 1978; policy confound

Gabor 2003

Healthy participants received intervention

Hahn 1995

Study design

Harmankaya 2002

Study design

Hendrich 2004

Study design

Herr 2003

Study design, outcomes

Ittelson 1970

Study design

Janssen 2000

Outcome measure

Janssen 2001

Participants

Kaldenberg 1999

Study design

Kibbler 1998

Study design; confounding

Kulik 1996

Intervention

Leigh 1972

Study design

Levine 1973

Confounding

Lewis 1999

Study 1: inappropriate control; Study 2: intervention

Lidwell 1966

Study design

May 1984

Study design

McConnell 2005

Study design; unclear intervention

Miller 1998

Participants; Study design

Morgan 1998

Setting

Mulin 1997

Study design

Nauseef 1981

Policy changes

Parker 1965

Patients‐ 38% <10 years old

Preston 1981

Study design

Ribas‐Mundo 1981

Intervention (non‐environmental changes)

Rodriguez 1978

Policy confounding

Schimpff 1975

Policy confounding

Shooter 1963

Policy change

Silini 2002

Study design

Thompson 2002

Study design

Walsh 1989

Policy changes

Wilkins 1988

Study design

Williams 1962

Study design

Williams 1969

Study design‐ no control

Wood 1977

Validity of outcomes

Yates 1973

Policy confounding

Figures and Tables -
Table 18. Bedroom type: Characteristics of excluded studies
Table 19. Ceilings: Characteristics of excluded studies

Study ID

Reason for exclusion

Berg 2001

Participants (students)

Hagerman 2005

Study design

Figures and Tables -
Table 19. Ceilings: Characteristics of excluded studies
Table 20. Flooring: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Donald 2000

RCT; 2 x 2 design (2 x flooring, 2 x therapy).

DESCRIPTION: 54 in‐patients in an elderly care rehabilitation ward, in England.
NUMBERS: Linoleum floor = 26, Carpeted floor = 28.
AGE, mean: Linoleum floor = 82.75, Carpeted floor = 83.20
GENDER (male/female): Linoleum floor = 8/18, Carpeted floor = 2/26.
ETHNICITY: not described.
INCLUSION CRITERIA: All patients admitted for rehabilitation.
EXCLUSION CRITERIA: none described.

LINOLEUM FLOOR: Patient admitted to one of two four‐bed bays with latex vinyl square tile flooring.
CARPETED FLOOR: Patient admitted to one of two four‐bed bays with hospital‐duty flotex (Flotex® 200). This carpet was chosen because it has no pile facilitating bacterial build‐up; it also reduces the movement of equipment satisfactorily when the brakes are applied, but still enables easy wheeling of beds, chairs and commodes.

Patients were also allocated to either routine physiotherapy or additional exercises (stratified by flooring type). Outcomes relating to these groups are excluded from the review.

NUMBER OF FALLERS: obtained from the accident report forms.
NUMBER OF FALLS: obtained from the accident report forms.
INDEPENDENCE: obtained from the Barthel index.
LENGTH OF STAY: not enough data for extraction, no difference reported between groups.

Willmott 1986

RCT, cross‐over design, 2 conditions.

DESCRIPTION: 58 elderly hospital patients in England.
NUMBERS: 58 patients (cross‐over)
AGE: mean = 76.05 years old.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: not described.
EXCLUSION CRITERIA: not described.

CARPETED CORRIDOR: Each patient walked along the corridor towards a staff member standing 15 m ahead. Chalk marks were drawn at an interval of 10 m.
REFLECTIVE VINYL TILED CORRIDOR: Each patient walked along the corridor towards a staff member standing 15 m ahead. Chalk marks were drawn at an interval of 10 m.

GAIT SPEED and STEP LENGTH: The number of steps taken was counted from the time the patient crossed the first chalk line until the distal line was crossed by the leading forefoot, and elapsed time was measured by a stopwatch.

Patient specific differences not reported. Study reports significant differences on both outcomes in favour of the carpeted floor.

Gait speed (m/s):
Carpet = 0.48 (0.19), Vinyl = 0.40 (0.17)

Step length (cm):
Carpet = 33.72 (12.01), Vinyl = 29.50 (12.32)

Figures and Tables -
Table 20. Flooring: Characteristics of included studies
Table 21. Flooring: Characteristics of excluded studies

Study ID

Reason for exclusion

Anderson 1982

Paediatric hospital

Buemi 1995

Study design; outcomes

Cheek 1971

Qualitative

Hewawasam 1996

Study design

Hussian 1987

Study design

Skoutelis 1993

Study design

Thorne 1963

Qualitative evaluation

Figures and Tables -
Table 21. Flooring: Characteristics of excluded studies
Table 22. Furniture and furnishings: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Notes

Wilber 2005

RCT; 2 parallel groups.

DESCRIPTION: 132 elderly out‐patients admitted to the emergency department, in Ohio, USA.
NUMBERS: Chair group = 66, Gurney group = 66.
AGE, mean (SD): Chair group = 77 (7.2), Gurney group = 78 (6.7) years old.
GENDER (male/female): Chair group = 28/38, Gurney group = 27/39.
ETHNICITY: not described.
INCLUSION CRITERIA: Ambulatory outpatients; 65 years or older; able to sit upright, transfer, and engage in normal conversation.
EXCLUSION CRITERIA: Refused participation; too ill to participate (as determined by the Emergency Department attending physician); unable to follow the instructions to remain in the chair or gurney and use the call light for any transfers (determined by the study nurse).

CHAIR GROUP: Remained on the gurney until initial physician and nursing evaluations complete. Patients were then assisted to a reclining chair. Patients were told "it is now time to move to the chair" and if they asked why, they were told they had the option of now moving to the chair. Patients were assisted to a position of comfort. Patients can sit on the reclining chairs with the hips and knees flexed.
GURNEY GROUP: Remained on the gurney (the Emergency Department bed) throughout. The gurney has a thin foam mattress. Patients were assisted to a position of comfort.

PAIN: "The study nurse specifically instructed patients to rate pain associated with the gurney, rather than other sources." Measured on a NRS at three time points (time 0 = baseline; time 1 = one hour after randomisation; time 2 = two hours after randomisation). This outcome was dichotomised as favourable outcome (yes/no). A favourable outcome was considered as the patient having no pain at time 0 or time 1, or a decrease in pain from time 0 to time 1. An unfavourable outcome was defined as an increase in pain from time 0 to time 1, or no change in pain score if the patient complained of pain at time 0.
SATISFACTION: Satisfaction with the gurney or chair was measured on a VAS at the time of discharge or after two hours (which ever came first).

SDs for satisfaction were estimated from the 95% confidence interval (1.4, 2.8), assuming 66 patients per group.

Data extracted for pain at T1 for completeness of data. Results were slightly more pronounced at T2.

Figures and Tables -
Table 22. Furniture and furnishings: Characteristics of included studies
Table 23. Furniture and furnishings: Characteristics of excluded studies

Study ID

Reason for exclusion

Baldwin 1985

Outcomes and policy changes

Beldon 2002

Other systematic review in this area (Cullum 2008)

Cooper 1998

Other systematic review in this area (Cullum 2008)

Davies 1980

Study design

Dubbs 2003

Not a research study

Gray 2000

Other systematic review in this area (Cullum 2008)

Grindley 1996

Other systematic review in this area (Cullum 2008)

Hanger 1999

Study design

Holahan 1972

Test (not clinical) situation, policy change

Larsson 1991

Study design

Mayer 1991

Study design‐ inappropriate data

Nixon 2006

Other systematic review in this area (Cullum 2008)

Okada 1986

Not health‐related outcomes

Peterson 1977

Outcomes (validity and relevance)

Pring 1998

Other systematic review in this area (Cullum 2008)

Schott 1999

Policy change

Sommer 1958

Study design

Sherertz 1985

Intervention

Williams 1962

Policy changes with cleaning of blankets

Figures and Tables -
Table 23. Furniture and furnishings: Characteristics of excluded studies
Table 24. Hospital noise: Characteristics of excluded studies

Study ID

Reason for exclusion

Aaron 1996

No intervention‐ observational study

Baker 1987

No intervention

Baker 1992

No intervention

Baker 1993a

No intervention

Baker 1993b

Review article

Bame 1995

Study design

Biley 1994

Review article

Buemi 1995

Study design; outcomes

Falk 1973

No intervention

Gabor 2003

No intervention in patients

Gast 1989

Study design

Grumet 1994

Discussion article

Haddock 1994

Study design

Harrison 1989

Study design

Haslam 1970

Study design

Hilton 1976

Study design

Hilton 1985

No intervention

Kam 1994

Review article

Lamont 1975

No intervention

Lan‐Ping 2000

Policy confound

Moore 1998

Policy change

Pimentel‐Souza 1996

Study design (cross‐sectional, no intervention)

Yinnon 1992

Study design

Figures and Tables -
Table 24. Hospital noise: Characteristics of excluded studies
Table 25. Lighting: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Notes

Walch 2005

CCT; 2 parallel groups.

DESCRIPTION: 89 post‐operative in‐patients recovering from elective cervical and lumbar spinal surgeries in single patient rooms, Pittsburgh, USA.
NUMBERS: Bright room = 44, Dim room = 45.
AGE, mean (SD): Bright room = 60.1 (13.7), Dim room = 57.6 (13.4) years old.
GENDER (male/female): Bright room = 25/19, Dim room = 18/27.
ETHNICITY (Caucasian/other): Bright room = 42/2, Dim room = 40/5.
INCLUSION CRITERIA: undergoing elective cervical and lumbar spinal surgery. Admitted to single‐occupancy room.
EXCLUSION CRITERIA: Discharge on day after surgery; history of major depression or use of antidepressant medications.

BRIGHT ROOM: On west side of the corridor. Received approximately 46% more natural sunlight than dim rooms (received on average 73,537 lux‐hours per day).
DIM ROOM: On east side of the corridor. The light to these rooms was blocked due to an adjacent building approximately 25 meters away (received on average 50,410 lux‐hours per day).

Rooms were of the same configuration and size. No attempt was made to control patient usage of window blinds and room lighting.

ANALGESIC CONSUMPTION: obtained via chart extraction and standardised to morphine equivalent mg/hr.
PAIN: Recorded on post‐operative day one and on the day of discharge via McGill Pain Questionnaire. On discharge those in the bright rooms reported less pain although this was not significant (P value = 0.058).
DEPRESSION: The Centre for Epidemiological Studies Depression Scale on first and last post‐operative day. There were no differences between groups.
ANXIETY: Measured using the POMS anxiety scale on first and last post‐operative day. There were no differences between groups.
STRESS: Measured using the Perceived Stress Scale on first and last post‐operative day. Patients in the bright rooms reported significantly less stress on day of discharge (P value = 0.035).

Analgesic consumption data extracted for entire LOS mg/hr.

POMS: Profile of Mood States

Figures and Tables -
Table 25. Lighting: Characteristics of included studies
Table 26. Lighting: Characteristics of excluded studies

Study ID

Reason for exclusion

Beauchemin 1996

Retrospective study

Beauchemin 1998a

Duplicate of Beauchemin 1998b

Beauchemin 1998b

Retrospective study

Benedetti 2001

Retrospective study

Diffey 1988

Study design

Fox 1986

Study design

Harrison 1989

Study design

Kolanowski 1990

Setting

Rosenthal 1985

Intervention

Satlin 1992

Intervention

Sheperd 2001

Study design

Van Someren 1997

Setting; Study design

Veitch 2001

Literature review

Figures and Tables -
Table 26. Lighting: Characteristics of excluded studies
Table 27. Technologies: Characteristics of excluded studies

Study ID

Reason for exclusion

Gaffney 1986

Setting; study design

Nelson Negley 1990

Setting; outcomes

Tideiksaar 1993

Intervention

Figures and Tables -
Table 27. Technologies: Characteristics of excluded studies
Table 28. Temperature: Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Frank 1992

CCT; 2 parallel groups.

DESCRIPTION: 97 surgical in‐patients undergoing lower extremity vascular reconstruction in an ORa in Maryland, USA.
NUMBERS: Warm OR = 63, Cold OR = 34.
AGE, mean (SD) [range]: 64.5 (1.1) [35 to 94] years old.
GENDER: not described.
ETHNICITY: not described.
INCLUSION CRITERIA: Scheduled for lower extremity vascular reconstruction.
EXCLUSION CRITERIA: not described.

WARM OR: Patient underwent operation in one of a group of ORs with the ambient room temperature maintained at 24.5 (0.4) degrees Celsius.
COLD OR: Patient underwent operation in an OR with an ambient room temperature maintained at 21.3 (0.3) degrees Celsius. This room was maintained as such because it was also used for cardiac surgery with hypothermic cardiopulmonary bypass.

All rooms had non‐recirculating airflow an no laminar flow system. Patients in each group were also randomised to receive general anaesthesia or epidural anaesthesia.

ORAL TEMPERATURE: Measured with an electronic digital thermometer, pre‐operatively (before being transported to the OR), immediately post‐operatively, on arrival at the ICU, and every hour for 24 hours.

Intraoperative decrease in temperature:
Warm OR (General Anaesthesia), [n = 30] = 1.0 (1.09)
Warm OR (Epidural Anaesthesia) [n = 33] = 1.0 (1.15)
Cold OR (General Anaesthesia) [n = 21] = 1.8 (0.92)
Cold OR (Epidural Anaesthesia) [n = 13] = 0.8 (0.72)

Ambient room temperature did not influence rewarming rate.

aOR = Operating Room.

Figures and Tables -
Table 28. Temperature: Characteristics of included studies
Table 29. Temperature: Characteristics of excluded studies

Study ID

Reason for exclusion

Ansari 1969

Study design

Hashiguchi 2005

Study design

Morris 1970

Study design

Plourde 1997

Intervention‐ temperature of equipment not ambient room temperature

Wyon 1968

Staff outcomes

Figures and Tables -
Table 29. Temperature: Characteristics of excluded studies
Table 30. Ward layout: Characteristics of excluded studies

Study ID

Reason for exclusion

Baldwin 1985

Not health‐related outcomes; policy changes

Barlas 2001

Not health‐related outcomes; query validity

Elmståhl 1997

Not a hospital setting

Good 1978

Qualitative

Karro 2005

Design; outcomes

Kim 1997

Not health‐related outcome

Lomas 1987

Outcomes

McKendrick 1976

Study design

Pattison 1996

Confounding staffing differences

Wilson 1983

Qualitative; participants

Figures and Tables -
Table 30. Ward layout: Characteristics of excluded studies
Table 31. Wayfinding: Characteristics of excluded studies

Study ID

Reason for exclusion

Butler 1993

Setting

Carpman 1983

Study design

Dickinson 1995

Setting

Mayer 1991

Study design‐ inappropriate data

Passini 1998

No intervention; comparison with healthy controls

Watanabe 1997

Not health‐related outcomes; conversation confounding

Weisman 1981

Setting

Wright 1993

Participants not patients

Figures and Tables -
Table 31. Wayfinding: Characteristics of excluded studies
Table 32. Windows: Characteristics of excluded studies

Study ID

Reason for exclusion

Keep 1980

Study design

Verderber 1983

Study design, validity of outcomes

Wilson 1972

Study design‐ retrospective

Figures and Tables -
Table 32. Windows: Characteristics of excluded studies
Table 33. Whole unit design (multifaceted): Characteristics of included studies

Study ID

Methods

Participants

Interventions

Outcomes

Notes

Kasmar 1968

CCT; 8 parallel groups (2 x rooms, 2 x psychiatrists, 2 x time of data collection).

DESCRIPTION: 115 applicants for out‐patient psychiatric treatment at the Neuropsychiatric Institute, Los Angeles, USA.
NUMBERS: UNCLEAR how many patients per group.
AGE: 16 to 66 years old, UNCLEAR if > 90% were 18 years old; 34% of patients were aged 16 to 22 years old.
GENDER (male/female): 56/59.
ETHNICITY: White = 115 (100%).
INCLUSION CRITERIA: The patients had neither interacted or seen the psychiatrist previously.
EXCLUSION CRITERIA: none described.

'BEAUTIFUL ROOM': Carpeted in burnt‐yellow carpeting and contained an abstract picture on one wall, a floor‐sized artificial plant, a wooden waste‐basket, and indirect lighting provided by a contemporary desk lamp. The room was neat and well kept.'UGLY ROOM': Carpetless, with beige asphalt floor tiling, overhead fluorescent lighting and was unkempt, with work papers strewn over the furniture and an overflowing grey metal wastebasket and ashtray. Both rooms were windowless offices of identical size (6 x 8 x 8 feet), wall covering, and colour. The furniture was the same (brown metal desks with beige formica tops, green leatherette desk chairs, and green and yellow leatherette side chairs. The offices varied only in decor.

ROOM RATINGS: not included in review.
PATIENT PERCEPTIONS OF PSYCHIATRIST: not included in review.
MOOD RATINGS: Recorded via the "Psychiatric Outpatient Mood Scale" [This scale is known as Profile of Mood States, POMS]. No significant differences were found in the rated mood state for the main variables of room, psychiatrist, or patient age or gender.There was a significant interaction (P value < 0.05) of 'psychiatrist x age x sex' on factor 5 (fatigue‐inertia), which the authors evaluate as a chance finding.

Data not presented in enough detail for extraction.

Vaaler 2005

CCT; 2 parallel groups.

DESCRIPTION: 56 psychiatric in‐patients in the seclusion area of an acute psychiatric ward in Norway.
NUMBERS: Refurbished wing = 31, Traditional wing = 25.
AGE, mean (SD): Refurbished wing = 37.7 (15.5), Traditional wing = 36.3 (16.5) years old.
GENDER (male/female): Refurbished wing = 17/14, Traditional wing = 11/14. ETHNICITY: not described.INCLUSION CRITERIA: Admitted to the seclusion area of the ward.
EXCLUSION CRITERIA: Contagious diseases; dementia; mental retardation; autism to an extensive degree; does not speak Norwegian or English.

REFURBISHED WING: Redecorated and refurbished with the aim of looking, as much as security permitted, like an ordinary Norwegian home: Wainscoting walls, colourful wallpaper and paintings, lowered ceilings, multiple lighting spots, tasteful curtains, wardrobes, chairs, flowers, personal items, Italian ceramic‐tiled bathroom.
TRADITIONAL WING: Had been refurbished 4 years prior to the study with: sparse furniture, walls in grey colours, lacking pictures, no window curtains, single lamps in the ceilings 4 m high, bathroom with grey, laminated paint all over, and patient rooms with a single bed and a chair of metal tubes. Rooms were well kept and had a few signs of damage.

SYMPTOMS AND PSYCHOPATHOLOGY: Scored on the Positive And Negative Syndrome Scale (PANSS) for schizophrenia, with the time criterion of the last 24 hours. Scale has scores for total, positive, negative, and general symptoms. Assessed on admittance, day 3, and at discharge from seclusion.
SYMPTOMS AND FUNCTION: Assessed on the Global Assessment of Function Scale‐ split version (GAF‐S). Assessed on admittance, day 3, and at discharge from seclusion.
BEHAVIOUR: Assessed on the Brøset Violence Checklist (BVC). This is a 6‐item observer rated scale scoring behaviours that predict imminent violence in psychiatric inpatients. Violent or threatening incidents were recorded with Staff Observation Aggression Scale‐ Revised (SOAS‐R). Assessed on admittance, day 3, and at discharge from seclusion.
LENGTH OF STAY.

Data extracted for change from baseline (beginning and end time‐points only).PANSS score for 'total' extracted for review. No significant difference was found on any of the subscales.

Figures and Tables -
Table 33. Whole unit design (multifaceted): Characteristics of included studies
Table 34. Whole unit design (multifaceted): Characteristics of excluded studies

Study ID

Reason for exclusion

Alvermann 1979

Descriptive article

Anthony Williams

Descriptive article

Bame 1993

Study design

Barker 2005

Descriptive article

Berlet 1979

No intervention

Birdsong 1990

No intervention

Christenfeld 1989

CBA‐ Control sites and 'before' sites not clearly defined

Connell 1996

Review article

Coulson 1997

Setting

Counsell 2000

Policy confound

Covinsky 1998

Policy confound

Davidson 1971

Study design

Dennis 1988

Descriptive article

Devlin 1992

Study design

Donchin 2002

Review article

Dracup 1988

Review article

Freeman 1987

Study design

Greenberg 1992

Descriptive article

Gurr 1997

Descriptive case study

Hahn 1995

Study design

Harvey 1998

Review article

Harwood 1992

Study design

Holahan 1973

Outcomes

Holahan 1976

Outcomes

Hyde 1989

Qualitative; setting

Ingham 1997

Setting

Jastremski 1998

Literature review

Kovach 1997

Setting

Laitinen 1994

Intervention

Lawson 2000

Study design (same study as Lawson 2003)

Lawson 2002

Study design (same study as Lawson 2003)

Lawson 2003

Study design (before‐and‐after no contemporaneous control)

Lawton 1970

Study design

Leather 2003

Study design (before‐and‐after no contemporaneous control)

Liebowitz 1979

Study design

Martin 1998

Policy confound

McLaughlin 1976

Qualitative study

McGonagle 2002

Study design

McNaughton 2005

Study design

Meyer 1994

No intervention

Middelboe 2001

Confounding

Noskin 2001

Literature review

Notelovitz 1978

Study design

Oberle 1990

Study design

Okamoto 2002

Study design

Olsen 1984

Outcomes; unclear study design

Palmer 1998

Policy confound

Pattison 1996

Confounding staffing differences

Rubin 1998

Literature review

Rudy 1995

Intervention (care delivery systems)

Shirani 1986

Study design

Smith 1974

Follow‐up study (Smylie 1971, Davidson 1971); study design

Smylie 1971

Study design

Stahler 1984

Study design (gender differences)

Swan 2003

Study design

Tyerman 1980

Unclear intervention/control

Vietri 2004

Study design

Walker 1989

Qualitative interviews

Weber 1996

Overview article

Whitehead 1984

Study design

Winkel 1986

Descriptive case studies

Figures and Tables -
Table 34. Whole unit design (multifaceted): Characteristics of excluded studies
Comparison 1. Audiovisual distraction versus music

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anxiety Show forest plot

2

87

Std. Mean Difference (IV, Random, 95% CI)

‐0.24 [‐1.05, 0.56]

2 Pain Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Endoscopic procedural pain

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 post‐operative pain

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figures and Tables -
Comparison 1. Audiovisual distraction versus music
Comparison 2. Audiovisual distraction versus standard care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anxiety Show forest plot

3

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

2 Pain Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Totals not selected

Figures and Tables -
Comparison 2. Audiovisual distraction versus standard care
Comparison 3. Music versus blank tape / headphones only

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anxiety Show forest plot

10

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Pre‐procedural anxiety

4

361

Std. Mean Difference (IV, Random, 95% CI)

‐0.82 [‐1.03, ‐0.60]

1.2 Procedural anxiety

3

183

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.47, 0.23]

1.3 Post‐operative anxiety

3

220

Std. Mean Difference (IV, Random, 95% CI)

‐0.04 [‐0.52, 0.44]

1.4 ICU anxiety

1

64

Std. Mean Difference (IV, Random, 95% CI)

0.17 [‐0.32, 0.66]

2 Heart rate Show forest plot

8

543

Mean Difference (IV, Random, 95% CI)

0.40 [‐1.02, 1.82]

3 Blood pressure Show forest plot

8

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Systolic

7

533

Mean Difference (IV, Random, 95% CI)

‐0.40 [‐2.48, 1.67]

3.2 Diastolic

6

478

Mean Difference (IV, Random, 95% CI)

‐0.35 [‐2.08, 1.39]

3.3 Arterial

1

30

Mean Difference (IV, Random, 95% CI)

4.0 [‐5.33, 13.33]

4 Respiration rate: with choice of outcomes Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Post‐operative period for Ikonomidou 2004 and final scores (both studies)

2

119

Mean Difference (IV, Random, 95% CI)

‐1.72 [‐1.00, ‐0.44]

4.2 Post‐operative period for Ikonomidou 2004 and change score for Lee 2005

2

119

Mean Difference (IV, Random, 95% CI)

‐2.48 [‐3.85, ‐1.11]

4.3 Pre‐operative period for Ikonomidou 2004 and final scores (both studies)

2

119

Mean Difference (IV, Random, 95% CI)

‐0.92 [‐1.92, 0.09]

4.4 Pre‐operative period for Ikonomidou 2004 and change scores for Lee 2005

2

119

Mean Difference (IV, Random, 95% CI)

‐2.09 [‐4.51, 0.34]

5 Skin conductance Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

6 Stress hormones Show forest plot

3

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

6.1 Cortisol

3

216

Std. Mean Difference (IV, Random, 95% CI)

‐0.32 [‐0.73, 0.09]

6.2 Epinephrine

2

123

Std. Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.38, 0.33]

6.3 Norepinephrine

2

123

Std. Mean Difference (IV, Random, 95% CI)

‐0.08 [‐0.44, 0.27]

6.4 Adrenocorticotropic hormone (ACTH)

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐0.44 [‐1.17, 0.28]

Figures and Tables -
Comparison 3. Music versus blank tape / headphones only
Comparison 4. Music versus scheduled rest

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anxiety Show forest plot

8

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Procedural anxiety

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 ICU/CCU anxiety

7

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 Heart rate Show forest plot

4

180

Mean Difference (IV, Random, 95% CI)

‐2.76 [‐6.65, 1.13]

3 Blood pressure Show forest plot

4

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Systolic

3

140

Mean Difference (IV, Random, 95% CI)

‐1.51 [‐6.65, 3.63]

3.2 Diastolic

2

110

Mean Difference (IV, Random, 95% CI)

‐5.29 [‐8.78, ‐1.79]

3.3 Arterial

1

40

Mean Difference (IV, Random, 95% CI)

‐4.75 [‐13.98, 4.48]

4 Respiration rate Show forest plot

3

110

Mean Difference (IV, Random, 95% CI)

‐2.04 [‐3.43, ‐0.66]

Figures and Tables -
Comparison 4. Music versus scheduled rest
Comparison 5. Music versus standard care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anxiety Show forest plot

29

1812

Std. Mean Difference (IV, Random, 95% CI)

‐0.55 [‐0.74, ‐0.36]

1.1 Pre‐procedural anxiety

9

744

Std. Mean Difference (IV, Random, 95% CI)

‐0.37 [‐0.62, ‐0.12]

1.2 Procedural anxiety

15

865

Std. Mean Difference (IV, Random, 95% CI)

‐0.69 [‐1.02, ‐0.36]

1.3 ICU/post‐operative anxiety

5

203

Std. Mean Difference (IV, Random, 95% CI)

‐0.58 [‐1.01, ‐0.15]

2 Heart rate Show forest plot

21

1653

Mean Difference (IV, Random, 95% CI)

‐2.72 [‐4.70, ‐0.74]

3 Blood pressure Show forest plot

20

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Systolic

18

1437

Mean Difference (IV, Random, 95% CI)

‐1.76 [‐5.09, 1.56]

3.2 Diastolic

17

1407

Mean Difference (IV, Random, 95% CI)

‐0.97 [‐2.58, 0.63]

3.3 Arterial

2

186

Mean Difference (IV, Random, 95% CI)

‐9.86 [‐12.06, ‐7.65]

4 Respiration rate Show forest plot

9

Mean Difference (IV, Random, 95% CI)

Totals not selected

5 Sedation requirements (anxiolytics) Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 Midazolam (aka: Versed, Hypnovel, Dormicum, Dormonid), mg

3

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 Peripheral skin temperature Show forest plot

4

298

Std. Mean Difference (IV, Random, 95% CI)

0.15 [‐0.08, 0.37]

7 Oxygen saturation Show forest plot

3

150

Mean Difference (IV, Random, 95% CI)

‐0.71 [‐1.75, 0.32]

8 Mood state Show forest plot

2

170

Mean Difference (IV, Random, 95% CI)

‐1.18 [‐2.17, ‐0.19]

9 Satisfaction Show forest plot

2

174

Std. Mean Difference (IV, Random, 95% CI)

0.46 [0.16, 0.76]

10 Length of stay / Examination time Show forest plot

2

153

Mean Difference (IV, Random, 95% CI)

‐6.00 [‐10.72, ‐1.28]

Figures and Tables -
Comparison 5. Music versus standard care
Comparison 6. Music versus white noise

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Heart rate Show forest plot

2

144

Mean Difference (IV, Random, 95% CI)

4.67 [‐0.76, 10.10]

2 Blood pressure Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Systolic

2

144

Mean Difference (IV, Random, 95% CI)

‐1.80 [‐8.59, 5.00]

2.2 Diastolic

2

144

Mean Difference (IV, Random, 95% CI)

0.99 [‐7.60, 9.58]

Figures and Tables -
Comparison 6. Music versus white noise