Firmeza 2017.
Study characteristics | ||
Methods | RCT 2‐arm parallel‐group design |
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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 |
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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 |
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Outcomes | Anxiety (STAI‐S): change scores HR: change scores RR: change scores SBP: change scores DBP: change scores |
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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. |