Therapeutic touch for anxiety disorders
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To investigate the effectiveness and harms of therapeutic touch (Krieger 1997) with one or a combination of the following:
(1) Sham (mimic) TT.
(2) Pharmacological therapy.
(3) Psychological treatment.
(4) Other treatment.
(5) No treatment or waiting list.
Background
Description of the condition
Anxiety disorders are classified by the Diagnostic and Statistical Manual of Mental Disorders (DSM‐IV, APA 1994) as acute stress disorder, generalised anxiety disorder, post‐traumatic stress disorder, obsessive‐compulsive disorder, specific phobias, social anxiety disorder and panic disorder. Each of these disorders is characterised by uncontrollable and excessive worries, which may cause poor concentration and physical symptoms. Anxiety disorders are a common occurrence in modern society, with 12‐month prevalence rates estimated at 17% and with a lifetime prevalence of almost 25% (Kessler 1994). As chronic disorders, they have considerable impact on quality of life and have far reaching direct and indirect economic consequences (Greenberg 1999). Variability in the prevalence of specific anxiety disorders has been found between different countries and cultures (Weissman 1997). Furthermore, gender has been shown to impact on the prevalence of anxiety disorders, with women being more likely than men to develop them (Bijl 1998; Carter 2001; Wittchen 2002).
Description of the intervention
Psychological and pharmacological treatments are most commonly used in the treatment of anxiety disorders. Pharmacological treatments include benzodiazepines, azapirones or antidepressants, of which benzodiazepines are the most commonly used (Shader 1993). However, pharmacological therapy is often associated with adverse side‐effects (Lydiard 1997), with attitudes towards antidepressants consistently shown to be negative (Paykel 1998). There are a range of psychological therapies which have been shown to be effective and are commonly used to treat anxiety disorders (Borkovec 1993), including cognitive behaviour therapy and supportive psychotherapy and counselling. Nevertheless, psychological therapies are often impracticable due to the time and resource commitment required. Therefore, an effective and safe alternative intervention would be a welcome addition to the current repertoire.
Therapeutic touch (TT) was first developed in the 1970s by Dolores Krieger, then a nursing professor at New York University and Dora Kunz, a lay healer. Anxiety reduction, sometimes described as relaxation, is frequently cited as an effect of TT (Sayre‐Adams 2002; Olson 1997). Some research studies have reported that TT can reduce anxiety in the elderly (Lin 1998) and in burn patients (Turner 1998). Other studies have found no significant differences in the reduction of anxiety when TT is compared to mimic TT and routine treatment (Hale 1985).
How the intervention might work
The theoretical basis of contemporary TT is associated with the Science of Unitary Human Beings theory (Rogers 1970). Rogers views human beings as dynamic energy fields, and the world in which human beings live as an energy system, and suggests that there is a continual interaction within energy fields and with the environment. Therapeutic touch is defined as the detecting and balancing of energy. Good health is experienced when the flow of energy between the environment and the body is balanced (Krieger 1997). Imbalances and blockages in the energy field lead to illness and ill health. Since this energy field extends beyond the skin, physical touch is not required in order to practice TT.
The treatment involves two phases: assessment and balancing. Practitioners initially centre themselves by becoming relaxed and focused on the care about to be given, whilst the patient is encouraged to sit or lie comfortably. The practitioner moves their hands around the patient's body, at a distance of two to five inches, encountering and assessing the energy field by feeling for changes in temperature, pressure, rhythm or a tingling sensation. The balancing phase involves the practitioner redirecting and rebalancing energy through the use of hand movements. This phase aims to bring the two energy fields into a harmonic resonance. The practitioner then 'smoothes' out the patient's energy field by running their hands from head to toe. The treatment is typically concluded after 20 to 25 minutes or when the energy field is balanced (Hagemaster 2000). The administration of multiple TT treatments over a period of time appears to demonstrate a cumulative effect (Peck 1998; Turner 1998).
Why is it important to do this review
Since the introduction of TT in 1974, when first taught by Dolores Krieger to a group of Masters degree students, it has gained widespread support and is now reported to be taught in over 70 countries. Nevertheless, controversy still surrounds its effectiveness. Most of the research to date has focused on the effectiveness of TT in reducing anxiety, relieving pain and promoting healing (Krieger 1993). Whilst some studies support the claim that TT is effective (Heidt 1981; Kramer 1990), others have failed to do this (Olson 1995). Rosa has reported evidence that discredits the claims of TT and suggests that it should no longer be used by professionals (Rosa 1998). Challenges to Rosa's conclusions suggest that inappropriate design and analysis led to inaccurate conclusions (Cox 2003; Tall 2003). However, a Cochrane review of TT for healing acute wound healing found no evidence that it promotes healing (O'Mathuna 2003).
To date there has been no systematic review to investigate the strength of evidence for therapeutic touch in anxiety disorders. This review aims to provide a systematic summary of all currently available evidence on the effectiveness and harms of TT for anxiety disorders.
Objectives
To investigate the effectiveness and harms of therapeutic touch (Krieger 1997) with one or a combination of the following:
(1) Sham (mimic) TT.
(2) Pharmacological therapy.
(3) Psychological treatment.
(4) Other treatment.
(5) No treatment or waiting list.
Methods
Criteria for considering studies for this review
Types of studies
All randomised controlled trials and quasi‐randomised trials (eg randomisation using days of the week).
Types of participants
Adults (as defined by trialists) with anxiety disorders as diagnosed by the Diagnostic and Statistical Manual (DSM‐IV) (APA 1994), the International Classification of Disease (ICD‐10) (WHO 1992), other validated diagnostic instruments, or other self‐rated or clinician‐rated validated instruments that assess the level of anxiety symptoms, irrespective of gender, race or nationality.
Studies in which anxiety is a secondary symptom of a different disorder (for example depression or other psychiatric diagnoses) will be excluded.
Types of interventions
Therapeutic touch in this review is defined as the detecting and balancing of energy (Krieger 1997). Studies will be included if:
(1) The intervention is described as therapeutic touch.
(2) Is underpinned by Rogers theory (the science of Unitary Human Beings).
(3) Is supported by appropriate references.
Therapies which are described as therapeutic touch (eg Reiki, massage therapy) but do not meet the above criteria (2) and (3) will be excluded.
Comparison conditions may be one or a combination of:
(1) Sham (mimic) TT, in which an individual mimics the gestures used in the actual TT treatment whilst concentrating on another activity, for example counting. There is no intention on the part of the individual to facilitate the process of healing.
(2) Pharmacological treatment (eg anxiolytics or antidepressants).
(3) Psychological treatment (eg cognitive behavioural therapy, supportive psychotherapy or counselling).
(4) Other treatment (eg massage).
(5) No treatment or waiting list.
Types of outcome measures
Trials will be included that use at least one of the following outcomes:
Primary outcomes
(1) Reduction in anxiety symptoms, measured by self‐rating scales such as the trait subscale of the State Trait Anxiety Inventory (Spielberger 1983), Penn State Worry Questionnaire (Meyer 1990), the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS) (Zigmond 1983), the Beck Anxiety Inventory (BAI) (Beck 1988) or by clinician‐rated scales, such as the Hamilton Rating Scale (Hamilton 1959).
(2) Subjective assessments which measure a dichotomous outcome (improvement versus no improvement) will be included. The authors do however recognise the possible bias within these measures and if a difference is found in this outcome, greater reliance will be placed on the validated scales.
Symptom levels may be presented as continuous (mean and standard deviation) or dichotomous outcomes (remission/recovery versus non‐remission/non‐recovery).
Secondary outcomes
(1) Acceptability of therapeutic touch as a treatment (assessed by questioning of participants, satisfaction measures or drop‐outs).
(2) The number of people reporting adverse effects.
(3) Change in use of medication or use of other support systems.
Search methods for identification of studies
See: Depression, Anxiety and Neurosis Group search strategy.
(1) Electronic searches
CCDANCTR‐Studies
Diagnosis = Anxiety or Anxious or Agoraphobia or "Phobic Disorder*" or "Panic Disorder" or "Obsessive‐Compulsive Disorder" or "Post‐Traumatic Stress Disorders"
and
Free‐Text = touch
CCDANCTR‐References
Keyword = Anxiety or Anxious or Agoraphobia or "Phobic Disorder*" or "Panic Disorder" or "Obsessive‐Compulsive Disorder" or "Post‐Traumatic Stress Disorders"
and
Free‐Text = touch
The current Controlled Trials website will be searched (www.controlled‐trials.com).
The following search terms were used:
Therapeutic Touch or Therapeutic Touch and Anxiety
Full text e‐Journals
The Journal of Holistic Nursing
Terms used "Title=therapeutic touch"
1991‐2006
(2) Reference lists
The reference lists of identified studies will be inspected
(3) Personal communication
Personal communication with experts in the field will take place. Professional organisations contacted will include the British Association of Therapeutic Touch, the Nurse Healers Professional Association (USA), Sacred Space Foundation (UK) and Therapeutic Touch Network (Canada).
Data collection and analysis
Study selection
Abstracts of all publications obtained by the search strategy will be screened by two review authors for their relevance and design according to the selection criteria. For abstracts where the authors find any indication of a clinical trial, the full article will be obtained and assessed as to its relevance to this review. For articles written in a language other than English, help will be sought from the Cochrane Collaboration to translate and extract the data.
Quality assessment
Two independent reviewers will assess the methodological quality of the selected trials. In order to ensure that variation is not caused by systematic errors in the design of a study, the methodological quality of the selected trials will be assessed by two independent reviewers (JR and FB), using the criteria described in the Cochrane Handbook. The criteria are based on the evidence of a strong relationship between the potential for bias in the results and allocation concealment (Schulz 1995) and are defined below (Higgins 2005):
A. Adequate
B. Unclear
C. Inadequate
D. Allocation concealment not used.
Trials which meet A or B will be included.
Data extraction
Following an inclusion assessment, the methodology of the trial will be assessed by two reviewers independently (JR & FB). Data will be extracted on individuals, methods, interventions, outcomes and results. This data will be recorded on hard copy datasheets, then entered into RevMan 4.2 (RevMan 2004). Missing data and clarification on aspects of study design/data will be sought from the respective authors. When a disagreement cannot be resolved through discussion, an arbitrator will be utilised (CCDAN editor).
Data analysis
Data types
Post‐treatment outcomes will be assessed using dichotomous data on remission of anxiety symptoms, and continuous data of anxiety symptoms, using standardised measures.
Dichotomous data
If dichotomous outcomes are presented, the cut‐off points, designated by the authors as representing 'clinical improvement' will be identified and used to calculate a pooled relative risk (RR) and 95% confidence intervals (CI). If the author's definitions of these cut‐off points are quite different, only those studies that have use similar cut‐off points (eg 20% reduction in scores) will be combined into a pooled estimate. Where possible the number needed to treat (NNT) with 95% confidence intervals will be calculated. For each comparison a summary statistic of all those responding to treatment will be calculated as a percentage of the total number of participants.
Continuous data
For those completing trials, analysis of continuous data, based on the random effects model, will be conducted. If normally distributed, continuous data, measured in different ways across studies but conceptually the same, will be pooled using the standardised weighted mean difference (SMD). Where both endpoint and change data are available for the same outcome, the endpoint will be presented. Significance will be set at P< 0.05.
To ensure that the continuous measures data are normally distributed and that parametric tests can be used appropriately, the following standards will be applied to all data prior to inclusion:
(1) Standard deviations and means are obtained from the article or by contacting the author(s).
(2) For data with finite limits, such as the end point scale data, the standard deviation (SD), when multiplied by two should be less than the mean. If this is not the case, then it would be unlikely that the mean is an appropriate measure of central tendency (Altman 1996).
Data that are not normally distributed will be presented separately in an 'Other data types' table.
Fixed‐effect model and random‐effects model
If no evidence of heterogeneity is found, a fixed‐effect model will be used for both dichotomous and continuous data. A random‐effects model provides a more conservative estimate of effect and will be used if statistical heterogeneity is found.
Testing for heterogeneity
The following two formal tests of heterogeneity will be used:
(1) The chi‐squared test measures whether differences in effect estimates between studies may have occured due to chance (P value of 0.1 will be set, as the chi‐squared test lacks power where there are only a few studies for inclusion).
(2) The I‐squared test measures the percentage of difference in effect estimates between studies that is due to heterogeneity rather than chance. A value greater then 50% is considered substantial heterogeneity.
Sensitivity analyses
Sensitivity analyses will be performed to address the influence of diagnosis or cut‐off score as inclusion criterion, study quality (moderate/high), selection of scales (self/observer rated measures), intention‐to‐treat analysis, post randomisation exclusions and loss to follow up.
Subgroup analyses
Subgroup analyses will investigate whether:
(1)Trials which utilise different anxiety disorders differ in their results.
(2)Trials which used different environmental settings differ in their results.
(3)Trials which differ in the total number of TT sessions administered differ in their results.
Missing data
Intention‐to‐treat analysis of dichotomous outcome data will be carried out, it will be assumed that participants who dropped out had negative outcomes. For continuous outcomes end point data will be used (including only participants with a final assessment) or last observation carried forward (LOCF) if provided by trialists.
Tables and figures
Data relating to the training and experience of TT practitioners will be presented in a table.
Publication bias
Data from all selected trials will be entered into a funnel plot to investigate publication bias.
