Music Therapy During Hypothermia in the NICU

NCT ID: NCT06951269

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2027-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Music therapy condition

Live entrained music therapy

Group Type: EXPERIMENTAL

Live entrained music therapy

Intervention Type: 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.

Control condition

Standard care only

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Weeks
• Maximum Eligible Age: 44 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Santa Fe de Bogota

OTHER

Sponsor Role: lead

Responsible Party

Mark Ettenberger

Principal Investigator, Music Therapy Service FSFB

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., Colombia

Countries

Colombia

Central Contacts

Mark Ettenberger, PhD

Role: CONTACT

musicoterapia@fsfb.org.co

+573112847635

Facility Contacts

Mark Ettenberger, PhD

Role: primary

musicoterapia@fsfb.org.co

+573112847635

Other Identifiers

MTHYPOTHERMIA01

Identifier Type: -

Identifier Source: org_study_id