The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process in the Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Heart rate
研究概览
简要总结
The extubation process is critical to the future health outcomes of the pediatric patient because it tests the ability of the respiratory system to function without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety, or discomfort in the patients, which results in an increased likelihood of reintubation. Music therapy has been shown to be effective in reducing anxiety and stress levels in ventilated adult patients, but studies evaluating the effect of music therapy on vital signs in pediatric patients during extubation are lacking.
The aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in Colombia.
This study is a Randomized clinical trial (RCT) with two parallel arms. The intervention group (IG) will receive standard care during the extubation process + music therapy and the control group (CG) will receive standard care only. The primary outcome measure is heart rate (HR) measured every minute for 5 minutes before extubation, during extubation, and up to 10 minutes after extubation. Secondary measures are: oxygen saturation, respiratory rate, blood pressure, duration of the procedure, number of reintubations, and heart rate variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients hospitalized who are undergoing an extubation process.
排除标准
- •Pediatric patients with accidental extubation will be excluded.
结局指标
主要结局
Heart rate
时间窗: From 5 minutes pre-extubation to 10 minutes post-extubation.
It will be measured through pulse oximetry every minute.
次要结局
- Respiratory rate(From 5 minutes pre-extubation to 10 minutes post-extubation.)
- Oxygen saturation(From 5 minutes pre-extubation to 10 minutes post-extubation.)
- Blood pressure(From 5 minutes pre-extubation to 10 minutes post-extubation.)
- Heart rate variability(From 5 minutes pre-extubation to 10 minutes post-extubation.)
研究者
Claudia Aristizábal
Director
Sanitas University