Momennasab 2018.
Study characteristics | ||
Methods |
Study type: multicentre, RCT Design: 3‐arm, parallel group design Blinding: single blind |
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Participants |
Sample: adults with chronic renal failure n: 105 randomised (68 included in this review). 102 completed and included in the analyses Age: mean 49.86 (SD 11.12; range 18–60) years Sex: 56 men, 46 women (reported only for the 102 participants completing the trial) Setting: participants' homes Country: Iran |
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Interventions |
Intervention 1 (n = 33): bedtime music group. Standard treatment and listening to music at bedtime. Researcher‐chosen music. Participants administered the music themselves. They received a CD with the intervention music. The listening device was not reported. Music characteristics: 6‐piece piano improvisation created by Taylor Mesple (2015) in New Age (relaxation) genre Length of sessions: 50 minutes Frequency of sessions: daily at bedtime Duration of intervention period: 4 weeks Intervention 2 (n = 34): daytime music group (not included in review). Standard treatment and listening to music during haemodialysis Control (n = 35): standard treatment |
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Outcomes |
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Notes |
Trial start and end dates: May to December 2016 Funding sources: financially supported by the Vice‐Chancellor for Research Affairs, Shiraz University of Medical Sciences, Iran (Grant No 10571). Protocol registration: Iranian Registry of Clinical Trials (IRCT2016050217546N5) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: participants were allocated into 2 interventions and 1 control group by block randomisation with a block size of 3. |
Allocation concealment (selection bias) | High risk | Comment: with 3 groups and a fixed block size of 3, you would be able to foresee every third participant. |
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: "Data collection and analysis were carried out by a research assistant and a statistician who were blinded to the patient allocation groups" (Momennasab 2018, p 88). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: low attrition rate that is reported satisfactorily. |
Selective reporting (reporting bias) | Low risk | Comment: protocol available and outcomes well reported. |
Other bias | Low risk | Comment: no indication of additional bias. |