Clinical trial NCT06951269: Music Therapy During Hypothermia in the NICU
Official title: The Effect of Music Therapy on Pain Levels in Neonates With Hypoxic-ischemic Encephalopathy During Hypothermia: a Randomized Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Music Therapy
Pain
Allodynia
Neonates
NICU
Hypothermia Neonatal
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 22
Sex: ALL
Minimum age (years): 35
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Premature Infant Pain Profile - Revised (PIPP-R)
timeFrame: From start of the conditions to the end of the conditions, for about 30 minutes
Secondary outcomes:
measure: Heart rate
timeFrame: From start of the conditions to the end of the conditions, for about 30 minutes.
measure: Heart rate variability
timeFrame: From start of the conditions to the end of the conditions, for about 30 minutes.
measure: EEG - Electroencelography
timeFrame: From start of the conditions to the end of the conditions, for about 30 minutes.
measure: Salivary cortisol levels
timeFrame: From start of the conditions to the end of the conditions, for about 30 minutes.
measure: Oxygen saturation
timeFrame: From start of the conditions to the end of the conditions, for about 30 minutes.
measure: Respiratory Rate
timeFrame: From start of the conditions to the end of the conditions, for about 30 minutes.
Other outcomes:
measure: Viability and safety measures
timeFrame: From start of the conditions to the end of the conditions, for about 30 minutes.
Locations:
city: Bogota
country: Colombia
facility: University Hospital Fundación Santa Fe de Bogotá
Study officials:
References: