Stein 2010.
| Study characteristics | ||
| Methods | RCT 3‐arm parallel group design |
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| Participants | Adults awaiting CABG surgery or CABG plus aortic valve repair or replacement Total N randomized: 70 N randomized to music group: unclear N randomized to guided imagery: unclear (not used in this review) N randomized to control group: unclear N analyzed in music group: 17 N analyzed in control group: 19 N analyzed in guided imagery: 20 (not included in this review) Mean age: no information provided Sex: 8 (22%) women, 28 (78%) men Ethnicity: 36 (92%) white, 1 (3%) African‐American, 2 (5%) Hispanic Setting: inpatient and outpatient Country: USA |
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| Interventions | Two study groups: 1. Music group: participants listened to audiotapes at least once a day, every day, for 1 week before surgery. Participants were also asked to listen to their tapes intraoperatively 2. Control group: standard care which included access to CAM therapies, including audiotapes, upon request Music provided: Successful Surgery by Belleruth Naparstek without the pre‐recorded voice‐over providing imagery and affirmations Number of sessions: Varied Length of sessions: Varied Categorized as music medicine |
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| Outcomes | Anxiety (HADS ‐ anxiety subscale): change scores Depression (HADS ‐ depression subscale): change scores Mood disturbance (POMS): posttest scores |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "patients were randomly assigned via a coin toss" (p.215) |
| Allocation concealment (selection bias) | Low risk | Coin toss |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Music was self‐administered at home after participants filled out baseline measurements |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Self report measures were used for subjective outcomes |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | No objective outcomes were included in this study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Unclear how many participants were lost in the music and the control groups. In total (for 3 groups), 14 (20%) participants were lost. Reasons: 7 participants did not undergo CABG procedures or were transferred to another hospital; 7 did not complete the posttest. |
| Selective reporting (reporting bias) | Unclear risk | Not sufficient information available to make judgment |
| Other bias | Low risk | Funding for this study was provided by the Foundation for the Advancement of Cardiac Therapies. |