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Cochrane Database of Systematic Reviews Protocol - Intervention

Music therapy for acquired brain injury

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

(1) To identify randomized controlled trials (RCTs) examining the efficacy of music therapy in addressing recovery in patients with acquired brain injuries.
(2) To compare the efficacy of music therapy and standard care with (a) standard care alone, (b) standard care and placebo treatments, or (c) standard care and other therapies.
(3) To compare the efficacy of different types of music therapy interventions.

Background

Acquired brain damage embraces a range of conditions involving rapid onset of brain injury, including trauma due to head injury or post‐surgical damage; vascular accident such as stroke or subarachnoid hemorrhage; cerebral anoxia; toxic or metabolic insult such as hypoglycemia; and infection or inflammation (RCP 2004). Acquired brain injury can result in impairments in motor function, language, cognition, sensory processing and emotional disturbances. Hemiplegia and hemiparesis are common and may severely reduce a survivor's quality of life. Consequently, a primary concern in rehabilitation for acquired brain injury is the restoration of motor function. The improvement of ambulation and upper extremity function directly affects the level of independence of the patient related to activities of daily living. The individual is likely to be left with communication impairments, such as a severely reduced ability to understand, speak, and use spoken and written language, which can result in isolation. Furthermore, brain damage often leads to disturbances in memory, learning, and awareness. Sensory disturbances and neuropathic pain may result from damage to the nervous system. Finally, there may be behavioral implications resulting in disinhibition, apathy and motivation. Recovery of lost functions and skills after acquired brain damage is typically incomplete, putting survivors at increased risk for depression. Effective treatment of depression may bring substantial benefits by improving medical status, enhancing quality of life, and reducing pain and disability (van de Port 2007; Whyte 2006).

Acquired brain injury causes significant levels of disabilities which tend to result in long‐term problems. It is estimated that in 2003 there were 135,000 people living with long‐term problems following brain injury in the UK and a further 300,000 people living with disabilities stemming from stroke (NA 2003). Figures from the US exceed those in the UK, with an estimated 1.5 million people who sustain a traumatic brain injury each year, 80,000 to 90,000 of whom will be left with long‐term disability (NCIPC 2001). Approximately 5.3 million Americans or 2% of the population of all ages have long‐term or lifelong needs for help to perform personal activities of daily living following traumatic brain injury (Thurman 1999). Finally, the World Health Organization estimated that, in 2001, there were over 20.5 million strokes worldwide. With the population aging, even if the stroke incidence stagnates, the number of stroke patients requiring medical and rehabilitation care will rise dramatically over the next two decades (WHO 2002). Further work needs to be done to identify the direct and indirect financial costs of acquired brain injury to society within the UK (Turner‐Stokes 2003). However, within the US, the costs associated with traumatic brain injury alone were estimated to be in the vicinity of $60 billion for 2000 (Finkelstein 2006). Acquired brain injury therefore has significant effects on society in terms of human and economic costs.

Many innovative therapy techniques have been developed to help the restoration of lost functions and to aid in prevention and treatment of depression in acquired brain injury survivors. Music therapy has been used in rehabilitation settings to stimulate brain functions involved in movement, cognition, speech, emotions, and sensory perceptions. Interventions range from the use of rhythmic auditory stimulation to aid in the execution of movement and normalization of gait parameters (Thaut 1993), to music listening and singing to reduce pain (Kim 2005), to the use of music listening, music improvisations, composition and song discussions to address emotional needs and enhance the sense of well being (Nayak 2000). Music listening has also been used by non‐music therapists in rehabilitation settings to enhance relaxation, provide distraction, and reduce pain. It is important to distinguish music therapy interventions from the administration of music to patients by medical personnel. Interventions are classified as music therapy if the following components are present: (1) implementation of goal‐directed music interventions by a trained music therapist, and (2) the use of individualized music experiences. In rehabilitation settings, these interventions may include (1) listening and moving to live, improvised or pre‐recorded music as well as rhythmic auditory stimulation, (2) performing music on an instrument, (3) improvising music spontaneously using voice or instruments or both, (4) singing or vocal activities to music, (5) music‐based speech and language activities, (6) composing music, and (7) music combined with other modalities (e.g. imagery, art) (Dileo (in press)).

Several research studies on the use of music in rehabilitation of acquired brain injury have reported positive results. Most of these studies, however, have suffered from small sample size, making it nearly impossible to achieve statistically significant results. In addition, differences in factors such as study designs, methods of interventions, and intensity of treatment have led to varying results. A systematic review is needed to more accurately gauge the efficacy of music therapy as a rehabilitation intervention for people with acquired brain injury as well as to identify variables that may moderate its effects.

Objectives

(1) To identify randomized controlled trials (RCTs) examining the efficacy of music therapy in addressing recovery in patients with acquired brain injuries.
(2) To compare the efficacy of music therapy and standard care with (a) standard care alone, (b) standard care and placebo treatments, or (c) standard care and other therapies.
(3) To compare the efficacy of different types of music therapy interventions.

Methods

Criteria for considering studies for this review

Types of studies

All prospective RCTs, parallel group designs as well as cross‐over trials, of any language, published and unpublished, will be eligible for entry. As this review does not include temporary alleviation of symptoms, we will only include the first period of cross‐over trials. We will only consider including trials with quasi‐randomized or systematic methods of treatment allocation (e.g. alternate allocation of treatments) if a limited number of RCTs is found.

Types of participants

Patients of any gender and older than 16 years of age who have acquired brain damage of a non‐degenerative nature and are participating in treatment programs offered in hospital, outpatient or community settings. This will include traumatic brain injury, stroke or hemorrhagic accident, anoxia, infection and any mixed cause. We will exclude any condition of a progressive nature. We will not use the site of lesion and stage of rehabilitation as inclusion or exclusion criteria.

Types of interventions

The review will include all studies in which standard treatment combined with music therapy is compared with: (1) standard care alone, (2) standard care combined with other therapies, or (3) standard care with placebo. In addition, studies will be considered only if (1) music therapy is delivered by a formally trained music therapist or by trainees in a formal music therapy program and (2) one of the following music therapy interventions is used (Magee 2006):

  • clinical improvisation in which participants are involved in active music making in dialogue with the therapist using musical instruments or voice;

  • voice and singing techniques including song‐singing programs, melodic intonation therapy or modified melodic intonation therapy, vocal intonation therapy, rhythmic speech cueing, and therapeutic singing;

  • rhythmic auditory stimulation or rhythmic auditory cueing;

  • receptive techniques in which participants listen to music;

  • song‐writing;

  • any combination of above.

Types of outcome measures

The primary outcomes for this review will be:
(1) improvement in gait, measured by changes in gait velocity, cadence, stride length, stride symmetry, stride timing;
(2) improvement in upper extremity function, measured by hand grasp strength, frequency and duration of identified hand function, spatiotemporal arm control.

Secondary outcomes for this review will be:
(1) communication (e.g. language production, parameters of voice production, speaking fundamental frequency);
(2) mood and emotions (e.g. depression, anger, anxiety);
(3) social skills and interactions (e.g. eye contact, non‐verbal interactions);
(4) pain;
(5) behavioral outcomes (e.g. participation in treatment, motivation, self‐esteem);
(6) activities of daily living;
(7) adverse events (e.g. death, fatigue, falls).

Search methods for identification of studies

See: 'Specialized register' section in Cochrane Stroke Group

We will search the trials registers of the Cochrane Stroke Group, the Cochrane Injuries Group, the Cochrane Infectious Diseases Group and the Cochrane Cancer Network. In addition, we will search the following electronic databases and trials registers (Appendix 1):

  • Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, latest issue);

  • MEDLINE (1966 to present);

  • OLDMEDLINE (1950 to 1965);

  • EMBASE (1980 to present);

  • CINAHL (1982 to present);

  • PsycINFO (1967 to present);

  • LILACS (1982 to present);

  • AMED (1985 to present);

  • The Science Citation Index;

  • The specialist music therapy research database at www.musictherapyworld.net;

  • CAIRSS for Music;

  • Proquest Digital Dissertations;

  • ClinicalTrials.gov (http://www.clinicaltrials.gov/);

  • Current Controlled Trials (http://www.controlled‐trials.com/);

  • National Research Register (http://www.update‐software.com/National/);

  • Rehab Trials.org (http://www.rehabtrials.org/);

  • Indexes to Theses (British theses).

We will handsearch the following journals from the first available date:

  • The Arts in Psychotherapy;

  • Australian Journal of Music Therapy;

  • Australian Music Therapy Association Bulletin;

  • British Journal of Music Therapy;

  • Canadian Journal of Music Therapy;

  • The International Journal of the Arts in Medicine;

  • Journal of Music Therapy;

  • Musik‐,Tanz‐, und Kunsttherapie (Journal for Art Therapies in Education, Welfare and Health Care);

  • Musiktherapeutische Umschau;

  • Music Therapy;

  • Music Therapy Perspectives;

  • Nordic Journal of Music Therapy;

  • Music Therapy Today (online journal of music therapy);

  • New Zealand Journal of Music Therapy;

  • Voices (online international journal of music therapy).

In an effort to identify further published, unpublished and ongoing trials we will search the bibliographies of relevant studies and reviews, contact experts in the field, and search available proceedings of music therapy conferences. We will consult music therapy association websites to help identify music therapy practitioners and conference information (e.g. American Music Therapy Association (http://www.musictherapy.org), The British Society for Music Therapy (http://www.bsmt.org/), The Association of Professional Music Therapists (APMT) (http://www.apmt.org/), Music Therapy World (http://musictherapyworld.net)).

There will be no language restrictions for either searching or trial inclusion.

Data collection and analysis

Trial selection

The searches as outlined in the search strategy will be conducted by JB, BW, WM, and EM. One review author (JB) will scan titles and abstracts of each record retrieved from the search and delete obviously irrelevant references. When a title or abstract cannot be rejected with certainty, the full article will be obtained and inspected by two review authors (BW and WM) independently. Both review authors will use an inclusion criteria form to assess the trial's eligibility for inclusion. One review author (JB) will check the inter‐rater reliability for trial selection, and, in case of disagreement, a third review author (CD) will be consulted. If a trial is excluded, we will keep a record of both the article and the reason for exclusion.

Data extraction

Two review authors (JB and WM) will independently extract data from the selected trials using a standardized coding form. The review authors will discuss any differences in data extraction and will seek the input of a third review author (CD) when needed. We will extract the following data.

General information

  • Author

  • Year of publication

  • Title

  • Journal (title, volume, pages)

  • If unpublished, source

  • Duplicate publications

  • Country

  • Language of publication

Trial information

  • Study design (parallel group, crossover)

  • Randomization

  • Randomization method

  • Allocation concealment

  • Allocation concealment method

  • Level of blinding

Intervention information

  • Type of intervention (e.g. clinical improvisation, voice or singing technique, rhythmic auditory stimulation or rhythmic auditory cueing, music listening, song writing, combination)

  • Music selection (detailed information on music selection in cases of music listening, beat selection in cases of rhythmic auditory stimulation)

  • Music preference (patient preferred versus researcher selected in cases of music listening)

  • Professional level of music therapist (professional or student in training)

  • Length of intervention

  • Intensity of intervention

  • Comparison intervention

Participant information

  • Total sample size

  • N of experimental group

  • N of control group

  • Gender

  • Age

  • Ethnicity

  • Diagnosis

  • Site of lesion

  • Degree of neurological damage

  • Rehabilitation stage

  • Setting

  • Inclusion criteria

Outcomes

We will extract statistical information for the following outcomes (if applicable):
(1) parameters of gait (e.g. velocity, cadence, stride length, stride symmetry, stride timing);
(2) parameters of upper extremity function (e.g. hand grasp strength, frequency and duration of identified hand function, spatiotemporal arm control);
(3) communication outcomes (e.g. language production; parameters of voice production, speaking fundamental frequency);
(4) mood and emotion outcomes (e.g. depression, anger, anxiety);
(5) social Interactions outcomes (e.g. eye contact, non‐verbal interactions);
(6) pain;
(7) behavioral outcomes (e.g. participation in treatment, motivation);
(8) activities of daily living;
(9) adverse events (e.g. death, fatigue, falls).

Quality assessment of trials

Two review authors (CD and WM) will assess all included trials for trial quality, blinded to each other's assessment. Any disagreements will be resolved by discussion. We will use the following criteria for quality assessment.

Method of randomization

  • Was the trial reported as randomized? Yes/No

  • Was the method of randomization appropriate? Yes/No/Unclear

Randomization will be rated as appropriate if every participant had an equal chance to be selected for either condition and if the investigator was unable to predict to which treatment the participant would be assigned. Use of date of birth, date of admission, or alternation will be rated as inappropriate.

Allocation concealment

We will use the ratings of A ‐ adequate, B ‐ unclear , and C ‐ inadequate in accordance with section 6.3 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2006).
A ‐ adequate: methods to conceal allocation include (1) central randomization, (2) serially numbered, opaque, sealed envelopes, or (3) other descriptions with convincing concealment.
B ‐ unclear: authors did not adequately report on method of concealment.
C ‐ inadequate: allocation was not adequately concealed (e.g. alternation methods were used)

Blinding

With music therapy studies, it is not possible to blind participants and those providing the music therapy interventions. However, outcome assessors can be blinded. In this review, blinding will be marked as 'yes', 'no', or 'unclear' as it pertains to blinding of outcome assessors.

Intention‐to‐treat analysis

We will consider an intention‐to‐treat analysis adequate when the numbers of drop outs and the reasons for drop out are reported.

We will use the above four criteria to give each article an overall quality rating, based on section 6.7.1 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2006).
A ‐ low risk of bias, all four criteria met
B ‐ moderate risk of bias, one or more of the criteria only partly met
C ‐ high risk of bias, one or more criteria not met

We will use the overall quality assessment rating for sensitivity analysis. We will not exclude studies based on a low quality score.

Data analysis

One review author (JB) will enter all trials included in the systematic review into the Cochrane Review Manager software, RevMan 4.2. Two review authors (JB and BW) will independently conduct data analysis. We will present the main outcomes in this review as continuous variables. We will calculate standardized mean differences for outcome measures using the results from different scales; we will use mean differences for results using the same scales. We will calculate pooled estimates using the fixed‐effect model unless there is substantial heterogeneity, in which case we will use the random‐effects model. We will determine levels of heterogeneity using the I‐squared statistic (Higgins 2002). We will calculate 95% confidence intervals for each effect size estimate.

The following treatment comparison will be made:

  • music therapy versus standard care alone;

  • music therapy versus other therapies or placebo.

If possible, we will perform subgroup analysis on the primary outcomes by (1) type of music therapy intervention, (2) dosage of music therapy, and (3) diagnosis. We will conduct subgroup analyses as described by Deeks et al (Deeks 2001) as recommended in section 8.8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2006).

We will examine the influence of study quality using a sensitivity analysis where the results of including and excluding lower‐quality studies are compared.