Effectiveness of RMSSD-Based Adaptive Music Therapy (Skitii) in Reducing Treatment-Related Distress in Head and Neck Cancer Patients: A Randomized Controlled Trial

This randomized controlled trial evaluates the effectiveness of Skitii adaptive music therapy in reducing treatment related distress among head and neck cancer HNC patients undergoing radiotherapy and or chemotherapy. The study will enroll 70 patients 35 intervention 35 control at Yenepoya Medical College Hospital over 4 to 5 months. The intervention uses real time heart rate variability monitoring  RMSSD  Root Mean Square of Successive Differences  to personalize music selection during treatment. The system employs a novel two phase algorithm  Phase 1 to 2.5 minutes  uses heart rate to predict initial stress state and select appropriate music while RMSSD values are calculated  Phase 2   2 5 to 20 minutes uses RMSSD based real time adaptation. The adaptive algorithm learns individual patient responses and excludes ineffective music tracks  maintaining RMSSD more than or equal 30ms  indicating reduced stress . The control group receives static music therapy without real time adaptation. The primary outcome is reduction in anxiety measured by Hospital Anxiety and Depression Scale  HADS  at 3 weeks. Secondary outcomes include depression quality of life  treatment adherence HRV parameters  and blood cortisol levels. This minimal risk intervention addresses a critical gap in supportive cancer care  with 65 to 85 percentage of HNC patients experiencing significant treatment related distress.