RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Modified Yale Preoperative Anxiety Scale
研究概览
简要总结
RELAX Anaesthetics is a randomised clinical trial assessing the effectiveness of using an iPad app with art, music and games to relax and distract children, reduce anaesthetic induction time and make drug cost savings prior to surgery.
详细描述
The most distressing part of a parent's experience in hospital is watching a child undergo intravenous cannulation.1 This is commonly performed in the anaesthetic room prior to induction of anaesthesia. At Chelsea and Westminster Foundation Trust (CWFT) over 5000 children undergo operations every year. Traditional methods of distracting the child during have included blowing bubbles, storybooks, and a variety of toys and games. These methods are not always effective and may present an infection risk due to inability to clean between uses.
The use of an android/iPad provides a platform for effectively distracting the child with a choice of games, video and music, with the advantage of being cleaned between uses. Users of this platform are required to select the application that is most appropriate for the age, sex, method of anaesthesia, and compliance level of the child. To assist with this, the investigators have developed an application system that will select a range of entertainment applications appropriate for each child based on these four variables and hopefully help to keep children calm before their operations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children ages 2 -12 years
- •requiring general anaesthesia
- •ASA assessment of fitness for surgery score 1 - 3
排除标准
- •intravenous cannula already in situ
- •play therapist already in use
- •anaesthetist refusal to participate
- •parental / patient refusal to participate
- •sedative or opiate pre-med already administered
- •not requiring general anaesthesia
- •ASA assessment of fitness for surgery score 4 or 5
结局指标
主要结局
Modified Yale Preoperative Anxiety Scale
时间窗: Change between baseline and completion of cannulation (2 hours later)
An observational scale assessing distress levels
次要结局
- Paediatric Anaesthetic Emergence Delirium Score(Single measurement taken from observation over 15 minutes immediately following surgery)
- State Trait Anxiety Inventory(Change between baseline and completion of cannulation (2 hours later))