The Effect of Intraoperative Music on the Prevalence and Severity of Emergence Delirium in Paediatric Patients: A Randomised Controlled Trial
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
- 否
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
DR. Michelle Olivier
DR
University of Pretoria
