Clinical efficacy of five-element music therapy in alleviating psychological distress among patients undergoing maintenance hemodialysis: a multicenter, non-inferiority, randomized controlled trial

Background: Psychological distress is common in patients undergoing maintenance hemodialysis (MHD) and may compromise quality of life and treatment adherence. Music-based interventions have shown potential benefits for emotional symptoms; however, evidence on Five-Element Music Therapy (FEMT), a Traditional Chinese Medicine-based intervention, remains limited in the MHD population. To our knowledge, no randomized controlled trial (RCT) has directly compared FEMT with relaxation training (RT) in these patients. This study therefore aimed to evaluate the efficacy of FEMT in alleviating psychological distress in patients undergoing MHD and to determine its non-inferiority to RT. Methods: A parallel-group randomized controlled trial was conducted in 140 patients MHD who met the predefined inclusion and exclusion criteria at hemodialysis centers of three tertiary hospitals in Yibin, China. Participants with psychological distress were randomly assigned in a 1:1 ratio to either the RT group or the FEMT group. Assessments were performed at baseline, posttreatment (week 4), and 1-month follow-up using the validated Distress Thermometer (vDT), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Pittsburgh Sleep Quality Index (PSQI), and the Short Form-36 Health Survey (SF-36). The primary outcome was psychological distress measured by the vDT; secondary outcomes included anxiety, depression, sleep quality, and health-related quality of life. Non-inferiority was evaluated on the basis of vDT scores, with a prespecified non-inferiority margin of 1 point. Results: , 1.02-1.36) at the 1-month follow-up, with both estimates favoring FEMT. At both time points, the lower bound of the 90% confidence interval (CI) remained above the prespecified non-inferiority boundary, indicating that FEMT met the non-inferiority criterion relative to RT. In addition, because the lower bounds of the 90% confidence intervals were also greater than 0 at both time points, the results were statistically compatible with superiority of FEMT over RT. Conclusion: Both FEMT and RT were associated with improvements in psychological distress among patients undergoing MHD. FEMT met the prespecified non-inferiority criterion and was statistically compatible with superiority over RT at posttreatment and at the 1-month follow-up. These findings support the short-term clinical value of FEMT as a culturally adapted intervention for psychological distress in patients undergoing MHD. Trial registration: itmctr.ccebtcm.org.cn, Identifier: ITMCTR2026000143.