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

Firmeza 2017.

Study characteristics
Methods RCT
2‐arm parallel‐group design
Participants Adults in the post‐surgical period, undergoing chemotherapy or radiotherapy
Type of cancer: head and neck (n = 40, 100%)
Total N randomized: 40
Total N analyzed: 40
N randomized to music group: 20
N randomized to control group: 20
N analyzed in music group: 20
N analyzed in control group: 20
Mean age: not reported
Sex: 32 (80 %) females, 8 (20%) males
Ethnicity: not reported
Setting: outpatient
Country: Brazil
Interventions 2 study groups:
1. Music group: listening to classical music
2. Control group: standard care
Music selections provided: "Spring" from the Four Seasons composition by Vivaldi with 60 to 80 beats per minute. Its first musical movement, (Allegro) has an E Major tonality and quaternary rhythm (4/4). In the second movement (Largo), the tonality changes to C minor, and the rhythm becomes ternary (3/4). In its last movement (Allegro Pastorale), the tonality returns to E Major, and the rhythm becomes quaternary again (12/8).
Number of sessions: 1
Length of sessions: 30 min
Categorized as music medicine
Outcomes Anxiety (STAI‐S): change scores
HR: change scores
RR: change scores
SBP: change scores
DBP: change scores
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "For those who met the inclusion criteria, the randomization process was performed using the random number table generated in the Epi‐Info program version 7.1.4." (p. 2).
Allocation concealment (selection bias) Low risk "We emphasize that in order to guarantee concealment of the participant’s allocation, their designation was only known to the study administrator after opening a properly sealed envelope which contained the condition selected for that participant" (p. 2).
Blinding of participants and personnel (performance bias)
All outcomes High risk Control participants were not given headsets, therefore, personnel were not blinded. Participants were not blinded.
Blinding of outcome assessment (detection bias)
Objective outcomes Unclear risk Objective outcomes were collected, however, authors did not give details regarding who collected the data.
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 Attrition: n = 4 (9%)
Selective reporting (reporting bias) Low risk No evidence of selective reporting
Other bias Unclear risk No information was provided on funding source or conflicts of Interest.