Music Therapy During Hypothermia in the NICU

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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 t

Первичные конечные точки

• Premature Infant Pain Profile - Revised (PIPP-R) [Срок оценки: From start of the conditions to the end of the conditions, for about 30 minutes]

Вторичные конечные точки (5)

• Heart rate [Срок оценки: From start of the conditions to the end of the conditions, for about 30 minutes.]
• Heart rate variability [Срок оценки: From start of the conditions to the end of the conditions, for about 30 minutes.]
• EEG - Electroencelography [Срок оценки: From start of the conditions to the end of the conditions, for about 30 minutes.]
• Oxygen saturation [Срок оценки: From start of the conditions to the end of the conditions, for about 30 minutes.]
• Respiratory Rate [Срок оценки: From start of the conditions to the end of the conditions, for about 30 minutes.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Колумбия · 1 центр

• University Hospital Fundación Santa Fe de Bogotá — Bogotá

Идентификаторы

NCT: NCT06951269 · MTHYPOTHERMIA01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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