Burns 2018.
Study characteristics | ||
Methods | RCT 2‐arm parallel‐group design |
|
Participants | Adults undergoing chemotherapy infusion Type of cancer: breast/gynecological (n = 33, 43.4%), hematologic (n = 12, 15.8%), lung (n = 8, 10.5%), genitourinary (n = 5, 6.6%), gastrointestinal (n = 6, 7.9%), and missing data (n = 12, 15.8%) Total N randomized: 86 Total N analyzed: 76 N randomized to music and imagery group: 43 N randomized to music listening group: 43 N analyzed in music and imagery group: 40 N analyzed in music listening group: 36 Mean age: 47.45 years Sex: 48 (63.2%) females, 28 (36.8%) males Ethnicity: 57 (75%) white, 16 (21%) black or African‐American, 3 (4%) other Setting: outpatient Country: USA |
|
Interventions | 2 study groups: 1. Music and imagery group: delivered by board‐certified music therapist according to the following protocol: 1) discussion of issues (5‐10 min) to develop a session focus; 2) transition (1‐2 min) to relaxed seating position; 3) music and imagery (30‐35 min): a guided visualization, accompanied by recorded music, in which the music therapist helped the participant focus on one or more of the following: a) relaxing the body, b) changing breathing rhythm and depth, c) visualization, and d) connecting with the participant's spiritual or religious world. Visualizations could take a number of forms such as: a) images related to one's breathing, b) images of nature, c) supportive, nurturing images, d) images related to the effects of the chemotherapy on the participant's body, and e) positive images of personal importance to the participant; 4) review of the experience (5 min). 2. Music listening group: participants listened to preferred music genre as facilitated by a board‐certified music therapist following this format: 1) discussion of music preferences (5‐10 min); 2) participant selection of playlist based on preferred genre (1‐2 min); 3) preferred music listening (30‐35 min); 4) review of experiences (5 min). Music selections provided for music and imagery group: consisted of Western Art Music and new age genres and was selected by the music therapist from a list based on assessment of participant's need for structure and energy level. Music selections provided for music listening group: Music playlists were compiled by a research assistant by examining the Billboard charts for popular recordings and including the genres: country, new age, 2000s, Christian, jazz, 60s/70s, 80s/90s, classical (Western art music), Broadway, and spiritual. Number of sessions: 1 Length of sessions: 45‐50 min, during chemotherapy Categorized as music therapy |
|
Outcomes | Depression (Hospital Anxiety and Depression Scale (HADS): Mean, SE, and effect size Anxiety (HADS): Mean, SE, and effect size Locus of control (Multidimensional Health Locus of Control): Mean, SE, and effect size Coherence (Sense of Coherence Scale): Mean, SE, and effect size Distress (Impact of Events Scale (IES)): Mean, SE, and effect size Benefits finding ‐ Benefit Finding Scale: Mean, SE, and effect size |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants received their group assignment after pretest data collection, based on a simple 1:1 randomization scheme calculated by the Statistical Package for Social Sciences (SPSS v.10). A randomization scheme was created for each site" (p. 88). |
Allocation concealment (selection bias) | Low risk | "Participants received their group assignment after pretest data collection, based on a simple 1:1 randomization scheme calculated by the Statistical Package for Social Sciences (SPSS v.10). A randomization scheme was created for each site. The site Principal Investigator (PI) provided the site music therapist the participant’s group assignment after pretest measures were collected" (p. 88). |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded to study hypothesis but music therapists could not be blinded. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | No objective outcomes included |
Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Participants were blinded to study hypothesis therefore self‐report measure outcome assessment could be rated as low risk. Moreover, the research assistants who collected the self‐report measures were blinded to group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition rate: 9%. However, 3 people in the music listening and 6 people in the music imagery treatment arm withdrew. Reasons for withdrawal were unclear. |
Selective reporting (reporting bias) | Low risk | No evidence of selective outcome reporting |
Other bias | Low risk | This research was supported in part by the Arthur Flagler Fultz Research Fund awarded to Burns and Meadows (co‐PIs). |