Liu 2016.
Study characteristics | ||
Methods |
Study type: RCT Design: 2‐arm, parallel group design Blinding: not blinded |
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Participants |
Sample: pregnant women of 18–34 weeks of gestation, with sleep problems documented by PSQI scores > 5 n: 128 randomised, 121 completed and included in the analyses Age: not reported Sex: women Setting: participants' homes Country: Taiwan |
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Interventions |
Intervention (n = 65): music group. Standard prenatal care and music listening. Participants could choose among 5 types of researcher‐selected sedative music. They administered the music themselves. The listening device was not reported. Music characteristics: the choices of music included 5 CDs of different genres (Taiwanese orchestral music, western classical music, nature sounds, lullabies and crystal music). The music had a slow tempo (60–80 bpm) and the relaxing properties were confirmed by pregnant women in a pilot investigation. Length of sessions: minimum 30 minutes Frequency of sessions: daily at bedtime Duration of intervention period: 14 days Control (n = 63): standard prenatal care |
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Outcomes | Sleep quality (assessed with PSQI)
aOutcome not included in this review |
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Notes |
Trial start and end dates: no information provided Funding sources: funded by the National Science Council of Taiwan Protocol registration: none found |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: randomisation procedure not clearly described. |
Allocation concealment (selection bias) | Unclear risk | Comment: unclear information on the randomisation procedure and no information on measures taken to conceal allocation. |
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 | High risk | Comment: no blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: attrition was low, balanced and well reported. |
Selective reporting (reporting bias) | Low risk | Comment: no study protocol was found. There was no indication of reporting bias. |
Other bias | Low risk | Comment: no indication of additional bias. |