Music Therapy During Hypothermia in the NICU

NCT06951269 | Not Yet Recruiting

• 1 other identifier: MTHYPOTHERMIA01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Heart rate

  From start of the conditions to the end of the conditions, for about 30 minutes.

• Heart rate variability

  From start of the conditions to the end of the conditions, for about 30 minutes.

• EEG - Electroencelography

  From start of the conditions to the end of the conditions, for about 30 minutes.

• Oxygen saturation

  From start of the conditions to the end of the conditions, for about 30 minutes.

• Respiratory Rate

  From start of the conditions to the end of the conditions, for about 30 minutes.

Other Outcomes (1)

• Viability and safety measures

  From start of the conditions to the end of the conditions, for about 30 minutes.

Study Arms (2)

Music therapy condition

EXPERIMENTAL

Live entrained music therapy

Behavioral: Live entrained music therapy

Control condition

NO INTERVENTION

Standard care only

Interventions

Live entrained music therapy BEHAVIORAL

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.

Music therapy condition

Eligibility Criteria

• Age: 35 Weeks - 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

Study Sites (1)

University Hospital Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., 110221, Colombia

Location

MeSH Terms

Conditions

Pain; Hyperalgesia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Central Study Contacts

Mark Ettenberger, PhD

CONTACT

+573112847635; musicoterapia@fsfb.org.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Main outcome measure will be evaluated through video analysis. The camera will be focused on the infant without the music therapist being in the frame. The sound will be muted.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Music Therapy Service FSFB

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 30, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will be available after publication of the results

Locations

CO (1)