Effectiveness of RMSSD-Based Adaptive Music Therapy (Skitii) in Reducing Treatment-Related Anxiety in Head and Neck Cancer Patients: Protocol for a Randomized Controlled Trial
Abstract
Background: Head and neck cancer (HNC) patients experience clinically significant anxiety in 65-85% of cases during active treatment. Anxiety is associated with treatment dropout rates reaching 26% in some cohorts, with each discontinuation resulting in suboptimal outcomes and estimated losses of INR 4-5 lakh per patient. Current supportive care lacks personalized, real-time non-pharmacological interventions. Skitii is an investigational medical device (CDSCO Class B, Licence SW/MD/MD13/2026/000003509) that uses continuous RMSSD monitoring via Polar H10 chest sensor to select music in real-time, targeting parasympathetic recovery (RMSSD >=30ms).
Methods: Prospective, open-label, randomized controlled superiority trial (1:1 allocation) at Yenepoya Medical College Hospital, Mangalore, India. Adults aged 18-75 years with confirmed HNC (any subsite, Stage I-IV) undergoing curative-intent radiotherapy and/or chemotherapy with baseline anxiety (HADS-A >=8 and =20%, targeting RMSSD >=30ms. Primary endpoint: HADS-A score change from baseline to Week 4. Secondary endpoints: treatment dropout rate, resting RMSSD, HADS-Depression, EORTC QLQ-C30, GAD-7, PHQ-9 and device validation (ICC >=0.90 vs Kubios HRV Standard). Sample size: 70 (35 per arm), powered at 80% to detect a 2.5-point HADS difference (SD=3.8, alpha=0.05, 15% dropout). Analysis: ANCOVA, intent-to-treat.
Discussion: This is the first randomized controlled trial evaluating RMSSD-based adaptive music therapy in cancer…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 15 participants or records.
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