Palmer 2015.
Study characteristics | ||
Methods | RCT 3‐arm parallel‐group design |
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Participants | Female cancer patients Type of cancer: breast cancer Total N randomized: 207 N randomized to live music group: 69 N randomized to recorded music group: 70 N randomized to control group: 68 N analyzed in live music group: 68 N analyzed in recorded music group: 68 N analyzed in control group: 65 Mean age: 59.4 years Sex: 207 (100%) females Ethnicity: 150 (74.6%) white, 46 (22.9%) black, 3 (1.5%) Asian, 2 (1%) Latino Setting: inpatient Country: USA |
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Interventions | 3 study groups:
Music selections provided: patient‐preferred music Number of sessions: 1 Length of sessions: 5 min Categorized as: music therapy |
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Outcomes | Anesthesia requirements: the amount of propofol needed to reach sedation of Bispectral Index (BIS) score of 70 Anxiety (Global Anxiety‐VAS): change scores Recovery time: recorded as the interval between surgery end time and the time when the participant had met discharge criteria according to hospital policy and procedure, determined by the recovery nurse Participant satisfaction (Likert scale) |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants were randomly assigned at a 1:1:1 ratio to a control or one of two experimental groups with use of an online randomisation module, which ensured adequate concealment" (p. 3163). |
Allocation concealment (selection bias) | Low risk | "Participants were randomly assigned at a 1:1:1 ratio to a control or one of two experimental groups with use of an online randomisation module, which ensured adequate concealment" (p. 3163). "A permuted block randomisation scheme was used with random block sizes to prevent personnel from guessing the next assignment" (p. 3163). |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Music therapist and participants could not be blinded. |
Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Self‐report measures were used for subjective outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis was used for all analyses. 137 participants were randomized to the live music or the SC group; 133 completed all measurements. This represented a dropout rate of 3%. |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Low risk | "Supported by Grant No. J0251, from The Kulas Foundation. Assistance with REDCap was provided through Clinical and Translational Science Collaborative Grant No. UL1TR 000439 at Case Western Reserve University. The Kulas Foundation had no role in the design or conduct of the study; the collection, management, analysis, or interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication." |