NCT01908244已完成不适用
Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design
ARCIM Institute Academic Research in Complementary and Integrative Medicine4 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Numbers of desaturations < 90% per hour
研究概览
简要总结
The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 26 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 26-34 weeks; no use of CPAP (Continous Positive Airway Pressure) or any other form of mechanical ventilation; signed informed consent of the parents
排除标准
- •Heart defect or known cardiac arrhythmia; other diseases of the preterm and newborn period (including infections and chromosomal aberrations) which make an additional diagnostic and therapeutic intervention unacceptable; detection of deafness (TEOAE, transitory evoked otoacoustic emission)
结局指标
主要结局
Numbers of desaturations < 90% per hour
时间窗: physiological parameters are measured twice over a period of 2 hours and 15 minutes
次要结局
- DI < 85% (Desaturations <85%/hour)(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
- Tachycardia > 200 bmp/h(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
- PI(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
- State Trait Anxiety Inventory(If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention)
- additional music questions(If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention)
- DI < 80% (Desaturations <80% per hour)(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
- Oxygen saturation(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
- Apnoea > 4 sec /h(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
- Bradycardia < 80 bpm/h(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
- HRV-Parameters(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
- State of the child(If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention)
- Heart rate(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
- PTT(Physiological parameters are measured twice over a period of 2 hours and 15 minutes.)
研究者
研究点 (4)
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