跳至主要内容
临床试验/NCT02999542
NCT02999542Unknown不适用

The Effect of Intraoperative Music on the Prevalence and Severity of Emergence Delirium in Paediatric Patients: A Randomised Controlled Trial

University of Pretoria0 个研究点目标入组 40 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
The effect of music on the prevalence of emergence delirium in paediatric patients

研究概览

简要总结

The researchers are conducting a research study to see whether listening to music during an operation will have a positive effect on the way that children wake up from surgery/anaesthetic. It is a common phenomenon where children wake up unhappy, irritated and screaming (known as emergence delirium). Research have shown that music decreases anxiety and pain. The researchers want to see whether music can also influence a child's behaviour after emerging from anaesthesia. In other words whether they will be more calm and cooperative after listening to music while they are asleep during surgery. Should music have a positive effect, anaesthesiologists may use it in future to improve care of patients coming for surgery.

详细描述

Children coming for certain elective surgeries, where pain has been excluded as a confounding factor, will have headphones placed on their ears after induction of anaesthesia. They will be randomised to two groups, one will receive music and the other just silence. The headphones will be removed just before waking the patient up. In the recovery room the child's behaviour will be observed and will be scored according to a validated score. The two groups will then be compared to see whether music makes a difference to the behaviour after anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 2-7 years
  • American society of anaesthesiologists class I and II patients
  • Child has adequate hearing
  • Surgery or procedure under general anaesthesia
  • Receiving standardised anaesthetic
  • Type of surgeries included: orthopaedic, urological, paediatric surgery and ophthalmology
  • Minimum exposure to music must be 15minutes
  • Child may not receive any premedication

排除标准

  • American society of Anaesthesiologists class 3 and above
  • Emergency cases
  • Children with hearing problems
  • Cognitive impairment

结局指标

主要结局

The effect of music on the prevalence of emergence delirium in paediatric patients

时间窗: Up to 12 months

次要结局

  • The effect of music therapy on the severity of emergence delirium in paediatric patients.(Up to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DR. Michelle Olivier

DR

University of Pretoria

相似试验