Skip to content

Association of Classical Indian Music and Anxiety in post partum mothers with premature neonates admitted in Neonatal Intensive Care Unit

EFFECTS OF MUSIC MEDICINE ON ANXIETY AMONG PRIMIGRAVIDA MOTHERS OF PRETERM NEONATES: A RANDOMIZED CONTROLLED TRIAL - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088896
Enrollment
99
Registered
2025-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Music Medicine Group: 30 minutes of Music Medicine using Raga Kalyani and Hindolam played on the 7-stringed, fretted acoustic instrument, the Saraswati Veena played by co-principal in

Sponsors

Dr Bishnupriya Mukherjee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: It will consist of primigravida mothers with preterm infants (30- 36 completed weeks of gestation) born through normal vaginal delivery and who will be able to understand English or Kannada with anxiety as per the Perinatal Anxiety Screening Scale (PASS- preliminary screening tool)

Exclusion criteria

Exclusion criteria: 1. Those who will not consent to participate in the study 2. Those who will have known psychiatric illness 3. Those who will have severe or profound hearing loss 4. Those who will have postpartum complications in intensive care 5. Those who will have Preterm twins, with major congenital malformations, or on invasive ventilatory support 6. Those who will have prior experience of practicing yoga or other relaxation techniques

Design outcomes

Primary

MeasureTime frame
Mean change in maternal anxiety scores as measured (pre- and post-intervention) by the State-Trait Anxiety Inventory (STAI) Rationale: Anxiety in mothers of preterm neonates in the NICU is common and can negatively impact maternal well-being and infant care. STAI is a well-validated questionnaire that measures anxiety levels, distinguishing between state anxiety (anxiety about an event/situation, which in this case is the NICU experience) and trait anxiety (general predisposition).Timepoint: Day 1 to Day 7

Secondary

MeasureTime frame
Mean change in maternal anxiety scores as assessed by the Perinatal Anxiety Screening Scale (PASS) pre- and post-intervention Rationale: PASS for assessing anxiety specific to the perinatal period. It includes factors such as the baby s health, NICU stress, self-doubt, perfectionism, and breastfeeding concerns, all of which are closely linked to the study design and are therefore relevant to outcome generation.Timepoint: Baseline (Day 1) to Day 7.;Mean change in the Postpartum Bonding Questionnaire (PBQ) scores as measured (pre-intervention) Rationale: Multiple RCTs and meta-analyses in NICU mothers support a positive correlation between music exposure and increased oxytocin levels.Timepoint: Baseline (Day 1) to Day 7 (post-intervention).;Mean change in the volume of breast milk expressed Rationale: Maternal anxiety and NICU separation can impair milk production, while music has been shown to increase oxytocin (facilitating milk letdown), reduce cortisol (stress hormone), and, as demonstrated by RCTs, enhance both breast milk volume and breastfeeding frequency.Timepoint: on Day 2 and Day 7;Mean change in maternal vital signs (blood pressure, pulse rate, and respiratory rate) measured pre- and post-intervention Rationale: Physiological parameters such as blood pressure, respiratory rate, and pulse rate serve as indicators of autonomic nervous system response, and multiple RCTs and meta-analyses report that music-based interventions modulate these measures.Timepoint: from Day 1 and Day 7;Mean change in neonatal weight in grams Rationale: Neonatal weight is included as a secondary outcome to explore the indirect impact of the maternal music intervention on infant health, specifically through its potential effects on maternal lactation and caregiving behaviors. Weight gain in the first week of life is a recognized indicator of adequate nutrition and overall neonatal well-being, particularly relevant for preterm infants in NICU settings. Timepoint: Day 1 and

Countries

India

Contacts

Public ContactDr Bishnupriya Mukherjee MBBS

Kasturba Medical College Mangalore

nutan.kamath@manipal.edu919448147687

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026