Impact of Intraoperative Music Application on Postoperative Behaviour in Children and Adolescents.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Occuring of a behaviour change
研究概览
简要总结
The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents.
详细描述
After induction of anesthesia, paralyzation of the patient and subsequent intubation, a caudal block is applied. After positioning of the patient, headphones are placed on the patients head and in case of the interventional group, music is played. Previously, the volume of the music is adjusted to a range from 50 to 60 decibel. Headphones are removed before extubation.
Postoperative behaviour is evaluated by parents and by caretaking personnel in the recovery room at arrival, after 15 minutes and before discharge to the ward and at home by parents after one, two and four weeks using questionnaires.
sample size calculation: n = minimal number of required probands π = 70% (proportion of interest) → 0.7 π0 = 50% (null hypothesis proportion) → 0.5 μ = (100% - 90%power) → 1.28 v = 1.96 (level of significance p=0.05)
n > [ μ√ π(1- π) + v√ π0(1- π0)]2 / (π - π0) n > 61.4 + correction for drop-outs (+10%) n = 70 per group → 140 probands in total
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 4-16 years
- •American Society of Anesthesiologists (ASA) physical status of 1 and 2
- •elective inguinal herniotomy or circumcision
- •general anaesthesia with sevoflurane and caudal block
- •written informed consent available
排除标准
- •age <4 or >16.99 years
- •ASA physical status of 3 or higher
- •emergency surgery
- •no general anaesthesia with sevoflurane or/and caudal block
- •no written informed consent available
研究组 & 干预措施
Music group
music application
干预措施: music application (Other)
Music group
music application
干预措施: a caudal block (Drug)
Control group
only headphones
干预措施: only headphones (Other)
Control group
only headphones
干预措施: a caudal block (Drug)
结局指标
主要结局
Occuring of a behaviour change
时间窗: patients are followed during the first 4 weeks after the operation
Patients are followed during the first 4 weeks after the operation by parents using a questionnaire in order to detect behaviour changes after the operation.
次要结局
- occurring of postoperative vomiting(before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room)
- rating of the behaviour of the child in the recovery room by parents using a questionnaire(before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room)
- rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire(before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room)