Kullich 2003.
Study characteristics | ||
Methods |
Study type: randomised using a computer‐based randomisation list (Kullich 2014a [pers comm]) Design: 2‐arm, parallel group design Blinding: single blind; data assessment performed by non‐trial personnel (Kullich 2014a [pers comm]) |
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Participants |
Sample: adults with low back pain and sleep difficulties documented by PSQI scores > 5 n: 65 randomised, 65 completed and included in analyses Age: mean age reported by group (range 21–68 years); music group: mean 47.0 (SD 9.7) years, control group: mean 49.7 (SD 7.9) years Sex: 41 men, 24 women Setting: rehabilitation facility Country: Austria |
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Interventions |
Intervention (n = 32): music group. Participants administered the music intervention themselves. They listened to researcher‐selected music and relaxation instructions through headphones and received TAU. Music characteristics: CD 'Entspannung bei Schmerzen' (Mentalis Verlag, ISBN: 3‐932239‐95‐4). No further information provided Length of sessions: 25 minutes Frequency of sessions: once a day, no time specified Duration of intervention period: 3 weeks ± 2 days Control (n = 33): TAU |
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Outcomes |
aOutcome not included in this review |
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Notes |
Trial start and end dates: not provided. Funding sources: supported by the Ludwig Boltzmann Institut (Saalfelden), the Herbert von Karajan Centrum (Wien), Salzburg University, and the Mozart University (Salzburg). Protocol registration: none found |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: computer‐based randomisation list (Kullich 2014a [pers comm]) |
Allocation concealment (selection bias) | Low risk | Comment: allocation done by another person (not the doctor) who referred the participant to the trial (Kullich 2014a [pers comm]) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: due to the nature of the intervention, blinding of participants was not possible. It is likely that this affected the subjective measures of sleep. There was no information on the blinding of the personnel at the rehabilitation facility. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: data were assessed by non‐trial personnel (secretary). Data analysis was performed by a researcher who was aware of group allocation, but did not know the patients (Kullich 2014a [pers comm]). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no attrition or missing data (Kullich 2014a [pers comm]) |
Selective reporting (reporting bias) | Low risk | Comment: we found no published protocol on this study, but there was no indication of selective reporting. Measures on sleep quality were reported without SDs in the publication, but these were provided by the first author on request (Kullich 2014b [pers comm]). These data did not alter the conclusions of the trial. |
Other bias | Low risk | Comment: no other risk of bias detected |