Music medicine for diabetes, hypertension, and perceived stress: An open labelled randomized control trial in Sri Lanka.

BACKGROUND: Chronic stress is a recognized risk factor for poor glycemic control in type 2 diabetes mellitus (T2DM). Music has shown promise as a low-cost intervention for stress reduction, but evidence in T2DM remains limited. METHODS: We conducted an open-label, parallel-arm randomized controlled trial among adults with T2DM attending the National Hospital of Sri Lanka, Colombo. Participants were randomized to customized music medicine with usual care (n = 172) or usual care alone (n = 177) and followed for 3 and 6 months. Primary outcomes were HbA1c, blood pressure, pulse rate, and perceived stress measured by the Perceived Stress Scale (PSS-10). The primary analysis used a complete-case approach, with intention-to-treat sensitivity analysis using last-observation-carried-forward. RESULTS: At 3 months, the treatment group showed a significantly greater reduction in HbA1c (-0.87, 95% CI -1.46 to -0.28) and perceived stress (-3.23, 95% CI -5.26 to -1.20) than the control group. At 6 months, although HbA1c remained numerically lower in the treatment group, the between-group difference in the primary complete-case analysis was not statistically significant (-0.61, 95% CI -1.44 to 0.22). Age-stratified exploratory analyses suggested greater HbA1c reduction in the <60-year subgroup at 3 months, but these findings should be interpreted cautiously because no multiplicity adjustment was applied. No significant between-group differences were observed for systolic blood pressure, diastolic blood pressure and pulse rate. CONCLUSION: Customized music medicine may be a useful complementary intervention for reducing perceived stress and improving short-term glycemic control in adults with T2DM.