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

Jespersen 2019.

Study characteristics
Methods Study type: RCT
Design: 3‐arm, parallel group design
Blinding: single blind; data assessors blinded to group allocation
Participants Sample: adults with insomnia disorder according to DSM‐5 diagnostic criteria
n: 57 randomised (38 included in this review). 50 completed, 57 included in analyses
Age: mean 50.2 (SD 11.6, range 18–65) years
Sex: 12 men, 45 women
Setting: participants' homes
Country: Denmark
Interventions Intervention 1 (n = 19): music group. Participants could choose between 4 playlists of slow music of different genres (classical, new age, jazz and ambient). Participants administered the music themselves. They received an audio player designed to be used in bed (Audiocura M2).
Music characteristics: all music was instrumental, with a slow tempo, stable dynamics and a simple structure. The specific music of each playlist is provided in the publication.
Length of sessions: minimum 30 minutes
Frequency of sessions: daily at bedtime
Duration of intervention period: 21 days
Intervention 2 (n = 19): audiobook group (not included in review). Participants could choose between 4 audiobooks of different genres (short stories, tales and fairy tales, autobiographical novel, magical realism).
Control (n = 19): waitlist control group with no intervention
Outcomes

  1. Sleep quality (assessed with PSQI)

    1. mean (SD) at baseline, postintervention and 1‐month follow‐up

  2. Insomnia severity (assessed with ISI)

    1. mean (SD) at baseline, postintervention and 1‐month follow‐up

  3. Quality of Life (assessed with WHOQOL‐BREF, psychological subscale)

    1. mean (SD) at baseline, postintervention and 1‐month follow‐up

  4. Sleep‐onset latency, minutes (assessed with PSG)

    1. mean (SD) at baseline and postintervention

  5. TST, minutes (assessed with PSG)

    1. mean (SD) at baseline and postintervention

  6. Sleep interruption, minutes (assessed with PSG, wake after sleep onset)

    1. mean (SD) at baseline and postintervention

  7. Sleep efficiency, % (assessed with PSG)

    1. mean (SD) at baseline and postintervention
Notes Trial start and end dates: March 2015 to April 2017
Funding sources: TrygFonden, Grant/Award No 109461
Protocol registration: ClinicalTrials.gov (NCT02321826)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Fifty‐seven persons were randomly allocated to one of the three groups by the drawing of lots." (Jespersen 2019, p 3).
Allocation concealment (selection bias) Low risk Quote: "The bowl was prepared by administrative staff with no knowledge of the study." (Jespersen 2019, p 3).
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: it is not possible to blind participants to the music intervention.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Comment: assessor‐blinded RCT.
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.
Selective reporting (reporting bias) Low risk Comment: study protocol was available and all of the study's prespecified (primary and secondary) outcomes that are of interest in the review were reported in the prespecified way.
Other bias Low risk Comment: no indication of additional bias.