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

Amiri 2019.

Study characteristics
Methods Study type: RCT
Design: 2‐arm, parallel group design
Blinding: not blinded
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
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
Outcomes
  1. Sleep quality (assessed with PSQI)

    1. mean (SD) at baseline and postintervention

  2. Insomnia severity (assessed with ISI)

    1. mean (SD) at baseline and postintervention

  3. Anxiety (assessed with DASS‐21)

    1. mean (SD) at baseline and postintervention

  4. Depression (assessed with DASS‐21)

    1. mean (SD) at baseline and postintervention

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)
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.