METHODS: This randomized controlled trial was conducted at Montaserieh Hospital, Mashhad, Iran, involving 72 patients undergoing hemodialysis. Participants were randomly assigned to either the intervention group, receiving a custom-designed recreational therapy mobile app (including music, comedy, exercise, and educational content), or the control group, receiving standard care. The trial was registered with the Iranian Registry of Clinical Trials (IRCT20220803055608N1). Outcome assessors and statisticians were blinded to minimize bias. Sample size was calculated for an expected effect size of 0.90 with 80% power, resulting in 36 participants per group, adjusted for a 6% attrition rate. Depression levels were assessed using the Beck Depression Inventory-II (BDI-II) at baseline and after a 30-day intervention.
RESULTS: A total of 72 patients (36 per group) completed the analysis. The intervention group showed a significant decrease in depression scores compared to the control group (mean BDI-II score reduction: intervention group = 10.3 ± 4.1, control group = 4.6 ± 3.8; p