Effect of group music therapy on state-anxiety and well-being levels of oncology patients undergoing chemotherapy: A multi-center randomized clinical trial

Mark Ettenberger^1,2*Laura Reyes Aragón^1,2Ana Maria Díaz^1,2Raúl Suárez^1,2Moshé Amarillo²Mariana Naranjo^1,2Claudia C. Colmenares-Mejía³

• ¹Clinica Colsanitas SA, Bogotá, Colombia
• ²SONO - Centro de Musicoterapia, Bogotá, Colombia
• ³Fundacion Universitaria Sanitas, Bogotá, Colombia

Background: Cancer patients undergoing chemotherapy may experience several mental health challenges, including increased levels of anxiety and affected well-being. Music therapy and other music-based interventions have previously been applied to improve patient mental health during chemotherapy, but multi-site RCTs that report live group music therapy interventions are scarce.Methods: This is a multi-site randomized clinical trial (RCT) with two arms: a single live group music therapy session + standard care and standard care alone. Primary outcome measure was the State-Trait Anxiety Inventory (STAI), and secondary outcome measures were the Well-being Numerical Rating Scales (WB-NRSs). Between-group differences in STAI and WB-NRSs scores were analyzed using the Wilcoxon rank-sum test. Intra-individual pre-post changes were assessed with the Wilcoxon signed-rank test. This study follows the CONSORT guidelines for reporting RCTs.Results: A total of 110 patients were included in this study. Results showed a statistically significant reduction of state anxiety from pre-to post-intervention for the music therapy group (p<0.001), but not for the control group. Between-group analysis showed significantly lower post-intervention STAI scores in the music therapy group as compared to the control group (p<0.001). With respect to wellbeing, only the music therapy group had statistically significant increases in all dimensions of wellbeing within-group from pre-to post timepoints, and between-group analysis showed statistically significant post-intervention differences in psychological (p = 0.005) and general well-being (p = 0.030) favoring the music therapy group. Effects of hospital sites on the outcomes were not significant. Discussion: The results suggest that group music therapy during chemotherapy is a safe and effective strategy to improve mental health and well-being in cancer patients. To our knowledge, this is the first multicenter RCT on group music therapy during chemotherapy in [country, de-identified for peer review]. Future studies should aim at integrating caregivers of chemotherapy patients and seek expansion to an international multi-site RCT.Clinical trial registration: clinicaltrials.gov (NCT06577324, submission date: August 21 st , 2024).