| Methods |
Design: three group parallel trial
Purpose: examine the effect of therapeutic touch on patients with dementia |
| Participants |
Patients: patients with Alzheimer's disease
Baseline comparability: yes (age, gender, degree of dementia) |
| Interventions |
Placebo: mimic treatment that resembled therapeutic touch to the naive observer (no attempt to enter 'a quiet meditative state ... instead the practitioner did mental calculations).
Untreated: no therapeutic touch
Experimental: therapeutic touch
(Co‐intervention: standard medical care). |
| Outcomes |
Modified Agitated Behavior Rating Scale (ABRS)
Revised Memory and Behavior checklist |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'random numbers table' |
| Allocation concealment? |
Unclear risk |
‘Envelopes containing group assignments were opened just prior to the intervention to ensure blinding of all concerned during the pre‐test measurement’ |
| Blinding?
Treatment provider |
Low risk |
'Using a double‐blind (masked), three‐group experimental pre‐test/post‐test design...' |
| Blinding?
Outcome assessor |
Low risk |
'Six blind observers collected all of the data on a Behavior Monitoring Chart (BMC)' |
| Incomplete outcome data addressed?
All outcomes |
High risk |
|
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
High risk |
N = 38 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
