Wang 2016.
Study characteristics | ||
Methods |
Study type: RCT Design: 2‐arm, parallel group design Blinding: single blind |
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Participants |
Sample: older adults (> 60 years), with poor sleep quality documented by PSQI scores > 7 n: 64 randomised, 64 completed and included in the analyses Age: mean 69 (SD 5.46) years Sex: 13 men, 55 women (unexplained discrepancy with total number of participants in the original report) Setting: participants' homes Country: China |
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Interventions |
Intervention (n = 32): music group. Sleep hygiene and music listening. Participants administered the music intervention themselves. They received an MP3 player with music database stored. Music characteristics: a music database of various types of music, including Chinese instrumental classic, Western classic, natural sounds music and classical songs without lyrics. The participants could find their preferred music from this database. All selected music was soft and sedative, with stable melodies at a tempo of 60–80 bpm. Length of sessions: 30–45 minutes Frequency of sessions: daily at bedtime Duration of intervention period: 3 months Control (n = 32): sleep hygiene |
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Outcomes |
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Notes |
Trial start and end dates: October 2011 to January 2012 Funding sources: no information provided Protocol registration: none found |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were assigned to the invention or control group by opening a sealed opaque envelope with a computer‐generated randomisation number indicating the group allocation" (Wang 2016, p 578–579). |
Allocation concealment (selection bias) | Low risk | Comment: with this randomisation procedure, the group allocation seemed well concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: it was not possible to blind participants to the music intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The follow‐up measurements were conducted by a research assistant, who had received training for administering PSQI and was blinded with the group allocations" (Wang 2016, p 579). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no attrition. |
Selective reporting (reporting bias) | Low risk | Comment: protocol was not available, but there was no indication of selective reporting. |
Other bias | Low risk | Comment: no indication of additional bias. |
BDI: Beck Depression Inventory, range 0–63, higher scores indicate more severe depression; bpm: beats per minute CD: compact disc; DASS‐21: Depression, Anxiety and Stress Scale, range 0–56, higher scores indicate more severe symptoms; DSM‐5: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; EEG: electroencephalogram; GEE: generalised estimating equation; HADS: Hospital Anxiety and Depression Scale, range 0–21, higher scores indicate more anxiety or depression; ISI: Insomnia Severity Index, range 0–28, higher scores indicate more severe insomnia; MLHFQ: Minnesota Living with Heart Failure Questionnaire, range 0–105, higher scores indicate poorer quality of life; MoCA: Montreal Cognitive Assessment, range 0–30, higher scores indicate cognitive impairment; n: number of participants; PSG: polysomnography; PSQI: Pittsburgh Sleep Quality Index, range 0–21, higher scores indicate poorer sleep quality; PSS: Perceived Stress Scale, range 0–40, higher scores indicate more perceived stress; R‐MDQ: Roland‐Morris Disability Questionnaire, range 0–24, higher scores indicate more disability; RCT: randomised controlled trial; REM: rapid eye movement; SD: standard deviation; SF‐12: 12‐item Short Form Health Survey, range 0–100, higher scores indicate better physical and mental health functioning; STAI: State Trait Anxiety Inventory, range 20–80, higher scores indicate more anxiety; TAU: treatment as usual; TST: total sleep time; VAS: visual analogue scale, range 0–10, higher scores indicate more symptoms, e.g. pain; WHO: World Health Organization; WHOQOL‐BREF: World Health Organization Quality of Life Scale, range 0–100, higher scores indicate better quality of life.