Amiri 2019.
Study characteristics | ||
Methods |
Study type: RCT Design: 2‐arm, parallel group design Blinding: not blinded |
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Participants |
Sample: adults with insomnia disorder based on the criteria in the second edition of the International Classification of Sleep Disorders n: 30 randomised, 30 completed and included in analyses Age: mean 27 (SD 2.5) years Sex: 30 men, 0 women Setting: participants' homes + 1 live session per week Country: Iran |
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Interventions |
Intervention (n = 15): music group. Participants listened to researcher‐selected Persian music administered themselves at home. The listening device was not reported. Music characteristics: the music included the Dastgahs of Nava and Bayat‐e Esfahan. The instruments used for playing were setar, tar, tonbak, kamancheh, oud and daf. The recorded music included songs from the works of Mohammad Reza Shajarian, Parviz Meshkatian, Hossein Alizadeh, Hossein Behroozinia, Ali Pajooheshgar, Masoud Shaari, Mohammad Reza Lotfi, Faramarz Payvar, Alireza Eftekhari, Salar Aghili, Amir Motavalli, and Gholam Hossein Banan. Length of sessions: 60 minutes Frequency of sessions: daily between 10 pm and 11 pm Duration of intervention period: 6 weeks (42 days) Control (n = 15): waitlist |
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Outcomes |
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Notes |
Trial start and end dates: no information provided Funding sources: sponsored by Kermanshah University of Medical Sciences, Iran Protocol registration: Iranian Registry of Clinical Trials (IRCT2017040425817N3) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "30 patients (mean age: 27) were enrolled and randomly assigned to the intervention (N = 15) and control (N = 15) groups." (Amiri 2019, p 2). Comment: no information on randomisation method. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on randomisation procedure or measures taken to conceal allocation. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not possible to blind participants to the music intervention. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no attrition and no indication of missing data. |
Selective reporting (reporting bias) | Low risk | Comment: results reported corresponded to protocol. |
Other bias | Low risk | Comment: no indication of other risk of bias. |