Effects of Oriental Music oN Preterm InfAnts: A Randomized Controlled Trial. (OMNIA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Heart rate variability
研究概览
简要总结
The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU.
详细描述
Music exposure during care of preterm infants is the subject of increasing research. Many studies have shown positive impact of music exposure such as classical western music, lullabies or Quran on pain and physiological parameters of preterm infants in a neonatal intensive care unit (NICU) setting. No such study have explored the effect of oriental music which is the main popular music listened to in the Levant and Middle East and North Afrika (MENA) region.
We aim in this study to find out if the oriental music exposure in preterm infants improves babies' heart rate variability, physiological parameters and behavior state during their NICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically stable infants born between 28 and 366/7 weeks of gestation and ≥31 weeks Post Menstrual Age (PMA).
- •Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment.
排除标准
- •Congenital anomaly affecting heart rate and hearing, significant brain insult (such as severe or moderate hypoxic ischemic encephalopathy, intraventricular hemorrhage (IVH) grade 3 or 4 or periventricular leukomalacia) that might affect the neurodevelopmental outcome.
- •Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine.
结局指标
主要结局
Heart rate variability
时间窗: 3 years
It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).
次要结局
- Mean Respiratory rate(3 years)
- Behavioral state(3 years)
- Oxygen Saturation(3 years)