Clark 1998.
Methods | RCT (cross‐over 2 weeks + 2 weeks) No information on data collection period reported |
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Participants | Country: USA 18 participants, (14 women, 4 men) Mean age: 82 (range 55 to 95) years, residents in a nursing home with Alzheimer‐type dementia Inclusion criteria: presence of dementia and a history of aggressive behaviour exhibited during care giving routines Presence of dementia was assessed with the MMSE (mean 10, range 0 to 22); most residents had severe dementia Exclusion criteria:
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Interventions | Experimental group: favourite music during bathing (receptive intervention) Control group: no music during bathing Following a 2‐week (10 sessions) observation period, conditions were reversed. A total of 20 sessions (bathing episodes; 10 control, 10 experimental) were observed over a period of approximately 4 weeks. Probably the intervention was provided for all bathing episodes and all were observed. |
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Outcomes | Behaviour: frequency of aggressive behaviours (no specific measure was used, but counts and mean counts across specific behaviours) | |
Notes | No information about funding available Note: the study also included younger people with dementia. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "After being enrolled in the study, participants were randomly scheduled for observation during bath time under either a control (no music) condition or an experimental condition." No further information provided on randomisation |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind the convener and participants |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information provided |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
Other bias | High risk | Questionable outcome measure and distribution. The authors reported in the article on the effects of the extreme intrasubject and intersubject variability characteristic of this population in this study. Quote: "For example, one subject was responsible for 408 and 84 occurrences of yelling behaviour in the no music and music conditions, respectively." Therefore, highly skewed distributions (the observation hardly occurred) causing imprecision. |