Leist 2011.
| Study characteristics | ||
| Methods | RCT 2‐arm parallel group design |
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| Participants | Adults who had a heart attack or a heart condition or both, including coronary heart disease, angina, valve disease, or arrhythmia, and had a heart procedure or surgery, including CABG, surgery or percutaneous transluminal coronary angioplasty (PTCA) with stenting, a valve replacement, or placement of a pacemaker or implantable cardioverter defibrillator (ICD) Total N randomized: 10 N randomized in music therapy group: 5 N randomized on control group: 5 N analyzed in music therapy group: 4 N analyzed in control group: 5 Mean age: 68 years Sex: 5 (56%) women, 4 (44%) men Ethnicity: 39 (100%) white (Italian) Setting: a group meeting room in a neutral non‐medical setting Country: USA |
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| Interventions | Two study groups: 1. Music therapy group: each session had an opening, music‐assisted relaxation (MAR), active music therapy, and a closing. 2. Control group: standard care (wait‐list control) Music provided: the active music‐making component included song lyric analysis, expressive singing, songwriting, and instrumental improvisation. Instrumental music selections were drawn from the classical and new age genres. The selections had tempi of 60 to 70 beats per minute, were 3 to 6 minutes in length, and had consistent tempo, dynamics, and instrumentation. The selections gradually increased in length and complexity as the sessions progressed and then ended with a shorter, less complex selection for the last session. The relaxation scripts included autogenic and image‐based inductions Number of sessions: 6 weekly sessions over 6 weeks Length of sessions: not reported Categorized as music therapy |
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| Outcomes | Stress (Hassles Scale): posttest scores Anxiety (POMS): posttest scores Depression (POMS): posttest scores Mood disturbance (POMS): change scores Anger‐Hostility (POMS): posttest scores Vigor‐Activity (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: "Each person was given a number between 1 and 10. Using a random number generator (Haahr, n.d.), the investigator assigned each person to one of the groups. A coin toss determined that the first five numbers would comprise the experimental group and the last five numbers would comprise the comparison group." (p.51) |
| Allocation concealment (selection bias) | Low risk | Allocation was concealed through both the drawing of lots and flip of a coin |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and personnel were unable to be blinded due to the interactive nature of the music therapy session |
| 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 | This study did not address objective outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rate: n = 1 (10%) One participant attended only one treatment session. |
| Selective reporting (reporting bias) | Unclear risk | Not sufficient information available to make judgment |
| Other bias | Low risk | Unfunded research study |