NCT01914341已完成不适用
Short-term Effects of Live Pentatonic Music on Physiological Parameters in Newborns Infants
ARCIM Institute Academic Research in Complementary and Integrative Medicine2 个研究点 分布在 1 个国家目标入组 20 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
- 20
- 试验地点
- 2
- 主要终点
- heartrate
研究概览
简要总结
The purpose of this study is to determine the effects of live music on physiological parameters in newborn infants. The mother is asked about the effects of music on her own and the child's wellbeing.
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
- None
入排标准
- 年龄范围
- 35 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥ 35 weeks
- •signed informed consent of the parents
- •positive proof of hearing ability (TEOAE, transitory evoked otoacoustic emission)
- •positive 10-minute Apgar-Score > 7
排除标准
- •Heart defect or known cardiac arrhythmia
- •other diseases of the preterm and newborn period (including infections and chromosomal aberrations)
- •participation in other studies
结局指标
主要结局
heartrate
时间窗: physiological parameters are measured twice over a period of 45 minutes
次要结局
- Breathing rate(physiological parameters are measured twice over a period of 45 minutes)
- Oxygen saturation(physiological parameters are measured twice over a period of 45 minutes.)
- Bradycardia < 80 bpm/h(physiological parameters are measured twice over a period of 45 minutes)
- Tachycardia > 200 bmp/h(physiological parameters are measured twice over a period of 45 minutes)
- heart rate variability-parameters (HRV)(physiological parameters are measured twice over a period of 45 minutes)
- Pulse-Transit-Time (PTT)(physiological parameters are measured twice over a period of 45 minutes)
- State of the child(Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).)
- Additional music questions(The additional music questions are filled in by the child's mother after the music intervention (during the15 minutes directly after the music intervention).)
- Apnoea > 4 sec per hour(physiological parameters are measured twice over a period of 45 minutes)
- State Trait Anxiety Inventory(Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).)
- Perfusion Index (PI)(physiological parameters are measured twice over a period of 45 minutes)
研究者
研究点 (2)
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