Music Therapy During Hypothermia in the NICU

The Effect of Music Therapy on Pain Levels in Neonates With Hypoxic-ischemic Encephalopathy During Hypothermia: a Randomized Pilot and Feasibility Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Music Therapy; Allodynia; NICU; Neonates; Hypothermia Neonatal
• Intervention / Treatment: Behavioral: Live entrained music therapy

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Ettenberger, PhD; Phone Number: +573112847635; Email: musicoterapia@fsfb.org.co

Study Locations

• Colombia
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 110221
      • University Hospital Fundación Santa Fe de Bogotá
      • Contact: Mark Ettenberger, PhD; Phone Number: +573112847635; Email: musicoterapia@fsfb.org.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Neonates diagnosed with neonatal hypoxic ischemic encephalopathy who have undergone hypothermic therapy as part of their medical treatment.

Exclusion Criteria:

• Newborns with a gestational age of less than 35 weeks and a birth weight of less than 1800 grams.
• Newborns in palliative care or with congenital anomalies with a poor prognosis will also be excluded, as will those with preexisting neurological or genetic conditions.
• Furthermore, newborns with a history of serious medical complications that may influence participation in the study, such as pulmonary hypertension or secondary seizure syndrome, will be considered ineligible.
• Finally, patients with an N-PASS score of less than -2 will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music therapy condition; Live entrained music therapy	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.
No Intervention: Control condition; Standard care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature Infant Pain Profile - Revised (PIPP-R)	The Premature Infant Pain Profile - Revised (PIPP-R) is a 10-item pain score used to assess pain in term and preterm infants. It consists of three indicators: physiological, e.g., heart rate and oxygen saturation; behavioral, e.g., facial expression; and contextual, e.g., gestational age. In the present study, for the behavioural part of the the PIPP-R we will use video recordings of the infant's face. Two raters will identify facial expressions associated with pain through one-minute video segments. The audio will be removed from the video, and measures will be taken to ensure that the music therapist does not appear in the recording, thus keeping the raters masked to the type of intervention.	From start of the conditions to the end of the conditions, for about 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate will be measured in beats per minute (BPM) and will be recorded continuously from 5 minutes before the routine nursing procedure, during the routine nursing procedure, during the music therapy intervention or the control condition, and up to 5 minutes after the intervention.	From start of the conditions to the end of the conditions, for about 30 minutes.
Heart rate variability	Telemetry recordings will be used to obtain electrocardiographic time series. This measurement provides an estimate of sympathetic and vagal tone, which has been linked to the outcome of infants with HIE during HT.	From start of the conditions to the end of the conditions, for about 30 minutes.
EEG - Electroencelography	Video telemetry recordings will be visually analyzed by the neurologist for patterns of seizure and abnormal activity; excessive discontinuities in the tracing, low voltage, or suppression of normal burst activity will be sought. These indicators correlate with the prognosis of the neonate with HIE during TH, the preservation of brain tissue, and the safety of the MT intervention.	From start of the conditions to the end of the conditions, for about 30 minutes.
Oxygen saturation	Oxygen saturation will be measured in percentage (%) and will be recorded continuously from 5 minutes before the routine nursing procedure, during the routine nursing procedure, during the music therapy intervention or the control condition, and up to 5 minutes after the intervention.	From start of the conditions to the end of the conditions, for about 30 minutes.
Respiratory Rate	Respiratory rate will be measured in numbers of respirations per minute and will be recorded continuously from 5 minutes before the routine nursing procedure, during the routine nursing procedure, during the music therapy intervention or the control condition, and up to 5 minutes after the intervention.	From start of the conditions to the end of the conditions, for about 30 minutes.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viability and safety measures	Number of events indicating hemodynamic instability or a negative change in vital signs during music therapy interventions and number of epileptic events during music therapy interventions. If music therapy sessions are discontinued in more than three patients, the study will be discontinued.	From start of the conditions to the end of the conditions, for about 30 minutes.

Collaborators and Investigators

• Sponsor: Fundación Santa Fe de Bogota

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Somatosensory Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Hyperalgesia
• Other Study ID Numbers: MTHYPOTHERMIA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available upon request
• IPD Sharing Time Frame: data will be available after publication of the results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No