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. 2021 Oct 12;2021(10):CD006911. doi: 10.1002/14651858.CD006911.pub4

Palmer 2015.

Study characteristics
Methods RCT
3‐arm parallel‐group design
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
Interventions 3 study groups:
  1. Live music group: music therapist played preferred music preoperatively; intraoperatively, music therapist played therapist‐selected music.

  2. Recorded music group: participant listened to self‐selected preferred music on MP3 player before the surgery; intraoperatively, the music therapist selected the pre‐recorded music.

  3. Control group: received usual preoperative care. Control participants wore noise‐blocking earmuffs during surgery to cancel any possible music played by the surgeon, until the conclusion of surgery.


Music selections provided: patient‐preferred music
Number of sessions: 1
Length of sessions: 5 min
Categorized as: music therapy
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)
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."