Effects of music medicine on anxiety among primigravida mothers of preterm neonates: The CalM MOM randomised controlled trial protocol

Background Preterm birth and Neonatal Intensive Care Unit (NICU) admission are significant stressors that heighten maternal anxiety. Although RCTs have reported that music-based interventions used alongside usual care (UC) are effective and low-cost in reducing maternal anxiety, evidence from India remains limited. Objective Primary objective is to assess the impact of listening to recorded classical Indian Instrumental Saraswati Veena music ( Ragas Kalyani and Hindolam ) (30-minutes/day over 7-days) alongside UC on maternal anxiety ( STAI-state anxiety) of primigravida women with preterm neonates in the NICU. Secondary objectives measure changes in anxiety (Perinatal Anxiety Screening Scale (PASS)), maternal-infant bonding, breast milk volume, and neonatal body weight. Method This three-arm parallel-group, superiority RCT among primigravida mothers with anxiety (screened using PASS) of preterm neonates (30–36 weeks of gestation, admitted to NICU) delivered vaginally at Government Lady Goschen Hospital, Mangalore. The intervention arm will receive Music Medicine (MM), the comparator arm Nature Sounds (NS), and the control arm UC. Participant blinding is not feasible (auditory intervention), and they serve as their own outcome-assessors (self-reported questionnaires); investigators and the independent statistician will remain blinded. Personnel interacting with participants are blinded to study objectives; enrolment/allocation staff blinded to the randomization sequence, and assessment staff blinded to group identity. Randomization will employ a STATA-generated, permuted stratified block design stratified by baseline anxiety severity and gestational age (Allocation concealment: Sequentially Numbered, Opaque, Sealed Envelopes; Allocation Ratio: 1:1:1). Sample size (66/arm; total N = 198) was determined through a simulation-based power analysis (5,000 iterations, base-R), assuming an MCID of 4 (MM) and 2 (NS) on the STAI, residual SD of ~8, powered at 80% (α = 0.05). Blinded sample-size re-estimation will be conducted at 50% enrollment completion. Primary powered analysis will employ ANCOVA (baseline-adjusted), and Secondary (exploratory) analyses will utilize a linear mixed-effects model for longitudinal continuous data with time × group interaction. Trial registration Clinical Trial Registry of India; CTRI/2025/06/088896; URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTM0Mzg0&Enc=&userName= Protocol version: Version 03, July 07, 2026