Cadigan 2001.
| Study characteristics | ||
| Methods | RCT 2‐arm parallel group design | |
| Participants | Adult cardiac patients with either intravascular sheets or an intra‐aortic balloon pump (IABP) in place.
Total N randomized: 140 N randomized to music group: 75 N randomized to control group: 65 N analyzed in music group: 75 N analyzed in control group: 65 Sex: 40 (29%) women, 100 (71%) men Mean age: 62.25 (SD 12.7) years Ethnicity: not reported Setting: Inpatient Country: USA |
|
| Interventions | Two study groups: 1. Music group: listening to researcher‐selected music through headphones 2. Control group: standard care Music provided: a mixture of symphonic music and nature sounds Number of sessions: 1 Length of session: 30 min Categorized as music medicine |
|
| Outcomes | Psychological distress (POMS‐Short Form): posttest scores HR, SBP, DBP: posttest scores Pain (VAS): posttest scores Peripheral skin temperature:posttest scores | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomized to either the treatment or control group by means of a table of random numbers."(p.8) |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants were not possible. Personnel were not blinded. |
| 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 | Unclear risk | It is unclear whether outcome assessors were blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rate: n = 10 (7%). Data on all randomized participants were obtained for physiological data but there was a loss of 10 subjects for the POMS data. No reason was reported. |
| Selective reporting (reporting bias) | Unclear risk | Not sufficient information available to make judgment |
| Other bias | Low risk | Supported by Eta Tau Chapter at Salem State College and Alpha Chi Chapter of Sigma Theta Tau International |