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Music Therapy During Hypothermia in the NICU
Sponsor: Fundación Santa Fe de Bogota
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.
Official title: The Effect of Music Therapy on Pain Levels in Neonates With Hypoxic-ischemic Encephalopathy During Hypothermia: a Randomized Pilot and Feasibility Study
Key Details
Gender
All
Age Range
35 Weeks - 44 Weeks
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2025-10-30
Completion Date
2027-08-01
Last Updated
2025-09-23
Healthy Volunteers
No
Interventions
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.
Locations (1)
University Hospital Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C., Colombia