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. 2022 Aug 24;2022(8):CD010459. doi: 10.1002/14651858.CD010459.pub3

Lai 2005.

Study characteristics
Methods Study type: RCT
Design: 2‐arm, parallel group design
Blinding: not blinded
Participants Sample: older adults with sleep problems documented by PSQI scores > 5
n: 60 randomised, 60 completed and included in analyses
Age: mean 67 (SD 5, range 60 to 83) years
Sex: not reported
Setting: participants' homes
Country: Taiwan
Interventions Intervention (n = 30): music group. Participants could choose among 6 types of researcher‐selected sedative music. Participants administered the music themselves. The music was recorded to an audiotape and participants could use earphones or not as preferred.
Music characteristics: the choices of music included 5 types of Western music (new age, eclectic, popular oldies, classical, and slow jazz), and 1 type of Chinese music (folk music). Tempos ranged from 60 to 80 bpm without accented beats, percussive characteristics or syncopation. The music was expected to be familiar to the participants.
Length of sessions: 45 minutes
Frequency of sessions: daily at bedtime
Duration of intervention period: 3 weeks
Control (n = 30): no intervention
Outcomes  
  1. Sleep quality (assessed with PSQI)

    1. mean (SD) at baseline and post‐intervention


 
Notes Trial start and end date: trial conducted in 2000
Funding sources: no information provided
Protocol registration: none found
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: permuted block randomisation with sealed envelopes stratified on gender
Allocation concealment (selection bias) Low risk Quote: "The envelopes were prepared by a different person so that the investigator (first author) was blind to block size and order of assignment" (Lai 2005, p 235)
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: due to the nature of the intervention, blinding of participants was not possible. It is likely that this affected the subjective outcome measures. The intervention was used at home with no personnel involved.
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: no blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: unclear information on attrition. 1 man was withdrawn due to hospitalisation. No information on completeness of data
Selective reporting (reporting bias) Low risk Comment: we found no published protocol on this study, but there was no indication of selective reporting.
Other bias High risk Comment: baseline differences in 2 sleep component scores, with the music group experiencing shorter sleep duration and more daytime dysfunction