The Effect of Music Therapy on Pain Levels in Neonates With Hypoxic-ischemic Encephalopathy During Hypothermia: a Randomized Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Premature Infant Pain Profile - Revised (PIPP-R)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 35 Weeks 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Neonates diagnosed with neonatal hypoxic ischemic encephalopathy who have undergone hypothermic therapy as part of their medical treatment.
排除标准
- •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.
研究组 & 干预措施
Music therapy condition
Live entrained music therapy
干预措施: Live entrained music therapy (Behavioral)
Control condition
Standard care only
结局指标
主要结局
Premature Infant Pain Profile - Revised (PIPP-R)
时间窗: From start of the conditions to the end of the conditions, for about 30 minutes
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.
次要结局
- 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.)
- 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.)
研究者
Mark Ettenberger
Principal Investigator, Music Therapy Service FSFB
Fundación Santa Fe de Bogota