Schou 2008.
| Study characteristics | ||
| Methods | RCT 2‐arm parallel group design |
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| Participants | Adults, valve replacement or valve replacement and CABG Total N randomized: 68 N randomized to music therapy group:25 N randomized to placebo group: 23 (not used in this review) N randomized to control group: 20 N analyzed in music therapy group: 22 N analyzed in control group: 19 N randomized in placebo group: 22 Mean age: 65 (SD 9.5) years Sex: 14 (21%) women, 54 (79%) men Ethnicity: not reported Setting: inpatient Country: Denmark |
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| Interventions | Two study groups: 1. Music therapy group: music‐guided relaxation 2. Control group: standard care Music provided: (a) Easy listening, (b) classical, (c) specially composed (musicure), (d) jazz Number of sessions: 1 pre‐operative session and up to 4 postoperative sessions (most participants received 2 postop sessions) Duration of session: 35 mins Categorized as music therapy |
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| Outcomes | Anxiety (VAS): posttest 2nd postop session Mood (POMS): posttest 2nd postop session Pain (VAS): posttest 2nd postop session Use of strong opioids (mg): on day of 2nd session Use of mild opioids (mg): on day of 2nd session Use of paracetamol (gram): on day of 2nd session Length of hospital stay |
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| Notes | Most participants only received 2 sessions postoperatively. Therefore, data of the 2nd postop sessions was used for this analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random block |
| Allocation concealment (selection bias) | Low risk | Use of codes as group labels, recruiters did not know what group the codes identified (personal communication with author) |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Music therapist and participants could not be blinded given the interactive nature of the music therapy session |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Self report measures were used for subjective outcomes |
| Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition: n = 4 (8.8%). Withdrawals due to early discharge. |
| Selective reporting (reporting bias) | Unclear risk | Not sufficient information available to make judgment |
| Other bias | Low risk | Unfunded research study |