of repeatedly and systematically involving the feedback of several types of actors in the development of an intervention, involving elements of qualitative research methodology (Kilstoff 1998), and ’demonstration project’ in which qualitative study of the practical experience with implementation at an institution, and the meaningful experience of family members involved, are given at least as much weight as quantitative findings (Sansone 2000). A large number of different rating scales, psychological tests and physiological measurements were used in the studies as measures of the outcomes described. A list of outcome measures is given in Additional Table 1. It is interesting to note that, although agitated behaviour and anxiety/relaxation are outcomes in most of the studies, no two studies measure them with the same instruments (except for those by Scherder et al., who repeated most of the elements of their own design; see ’Excluded studies’). Ratings of behaviour, mood etc. are typically performed by nursing staff or researchers, but in several cases this is not specified even though tests for reliability and validity are quoted. This review will adopt a sufficiently broad definition of massage and touch-related therapies to ensure that all the interventions of this family which are actually in use in dementia care can be included. O B J E C T I V E S Primary To assess the effectiveness of a range of massage and touch therapies offered to patients suffering from dementia. Secondary To give an overview of forms of massage which have been applied and studied in the context of dementia care. Massage and touch for dementia (Review) 3 Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. To systematically present information on experienced harmful effects and practical difficulties encountered. To provide recommendations for research in this area. M E T H O D S Criteria for considering studies for this review Types of studies We included randomised controlled trials (RCTs) in the review. We used studies with other research designs to provide background information only and have discussed these above. As the sensation and awareness of touch is likely to be essential to these interventions, study design elements such as placebo control, and blinding of patient and therapist, are probably not relevant and we did not give them positive weight in the review. However, we considered blinding in the assessment of response to be one important element of study quality. Useful information may be obtainedfrom trials comparing afull massage session with a session containing some of its elements only (e.g. aromatic oil alone) or merely talking to a sympathetic therapist; thus we included these also. We set no limits on the length of trials or the number of measurements made. Outcome measures should, however, be appropriate in the context of the length of the trial and the number of treatments. Although it makes sense to look for changes in ’soft’ measures of well-being and behaviour in the short term as a result of single sessions or a few treatments, effects on ’harder’ measures of cognitive ability and general health could be expected to emerge only after longer-term evaluation. Types of participants Patients with a diagnosis of dementia of any type, and receiving standard professional care for this condition, in their homes, in hospitals, or in residential institutions. Types of interventions Any type of massage and touch compared with other treatments, no treatment or placebo. This includes regular massage forms (’Swedish’, ’Esalen’ etc.) in which a touch with some pressure is applied in a moving way on parts of the body (typically the neck, shoulders or hands), therapies focused on finger pressure on specific points (reflexology, shiatsu), and ’therapeutic touch’ (i.e. interventions where the therapist’s hands may be held at a short distance from the patient’s body rather than in direct physical contact). In this context, a ’short distance’ means close enough to be perceived by patients as warm, intimate and bodily present (excluding, for example, prayer and distant healing.) Types of outcome measures 1. We sought reported changes in the frequency and severity of various types of agitated behaviour as observed by staff or investigators (using any rating method, and short term as well as long term), and in the emotional well-being and quality of life of the patients (rated by any method by staff, investigators and/or patients themselves). 2. Additionally, we considered outcomes in terms of cognitive abilities, survival, medication use, and caregiver burden. 3. We calculated overall response within a given type of outcome where appropriate. 4. We also considered global response, given that considerable individual differences in response are to be expected. Search methods for identification of studies We identified trials from a search of the Cochrane Dementia and Cognitive Improvement Group Specialized Register on 12 July 2005, using the terms massage, reflexology, touch and shiatsu. This Specialized Register at that time contained records from the following databases: • CENTRAL (Cochrane Central Register of Controlled Trials): January 2005 (issue 1) • MEDLINE: 1966 to 2005/02 • EMBASE: 1980 to 2005/01 • PsycINFO: 1887 to 2005/01 • CINAHL: 1982 to 2004/12 • SIGLE (Grey Literature in Europe):