Music Therapy During Hypothermia in the NICU

Summary

Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period. The main strategy to mitigate neurological damage is hypothermic therapy (HT), whose effectiveness-among other factors-depends on adequate pain management. Considering the prevalence of allodynia in this group of patients, routine nursing procedures can become sources of additional stress and pain. Music therapy is used in this population to promote self-regulation and relaxation, and may therefore help reduce pain levels after routine nursing procedures.

Research question: What is the effect of an entrainment-based live music therapy intervention on pain levels in newborns with hypoxic-ischemic encephalopathy undergoing hypothermic therapy after routine nursing procedures? Methodology: A randomized, crossover pilot and feasibility study. Participants will be 22 newborns admitted to the Neonatal Intensive Care Unit (NICU) of the University Hospital Fundación Santa Fe de Bogotá. Participants will receive standard care plus a 15-minute live music therapy session after a routine nursing procedure, or standard care alone. The primary outcome is the Premature Infant Pain Profile-Revised (PIPP-R) scale, which will be assessed through video recordings. Secondary outcomes are vital signs, heart rate variability, and electroencephalography (EEG) recordings.

Expected outcomes: Through this study, the aim is to improve the comfort and well-being of patients with HIE during TH. In addition, the safety and feasibility of music therapy in this population will be evaluated, seeking to contribute to current knowledge about the mechanisms of music therapy.

Conditions

• Music Therapy
• Pain
• Allodynia
• Neonates
• NICU
• Hypothermia Neonatal

Interventions

BEHAVIORAL

Live entrained music therapy

This study will use live, improvised, entrainment-based music. The music will be applied to synchronize with the newborns' breathing patterns, adapting the tempo to the breathing rate, with characteristics that seek to induce a state of relaxation in the patient: moderate volume (below 65 dB; this measure will be validated using the ambient noise indicator of the neonatal intensive care unit), simple harmonic sequences (tonic-subdominant-dominant), melodies that avoid large intervals (beyond a third), medium registers, and a stable pulse. Once the music therapist synchronizes the pulse of the music with the newborn's breathing, the music will be gradually become slower (approximately 10-15%), the volume will be adjusted, and the complexity of the music will be reduced until the patient can transition to a state of greater relaxation. The music therapy session will last 10 minutes, after which the music therapist will leave the room.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

35 Weeks

Max Age

44 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-30

Primary Completion

2026-12-31

Completion

2027-08-01

Countries

• Colombia

Study Locations