RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia

Conditions
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Surgery

Intervention / Treatment
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* Other: iPad app containing art, music and games
* Other: Toys, books and games


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children ages 2 -12 years requiring general anaesthesia ASA assessment of fitness for surgery score 1 - 3 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPad app containing art, music and games<br>On entry to the anaesthetic room, children will be given an iPad (the intervention) with art, music and games to distract them. A nurse will help them engage with the iPad whilst the anaesthetists complete the anaesthetic. Once the child falls asleep, the iPad will be removed. This process is anticipated to last between 3 and 30 minutes depending on the time taken to anaesthetise the child. | Other: iPad app containing art, music and games<br>* An iPad app that takes demographic information on a child and suggests suitable art, music and games for use by the anaesthetist and nurse to distract them during anaesthetics<br>|
| Active Comparator: Toys, books and games<br>On entry to the anaesthetic room, children will be given toys or games to distract them. A nurse will help them play whilst the anaesthetists complete the anaesthetic. Once the child falls asleep, the games will be removed. This process is anticipated to last between 3 and 30 minutes depending on the time taken to anaesthetise the child. | Other: Toys, books and games<br>* Games, books and toys used to distract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Yale Preoperative Anxiety Scale | An observational scale assessing distress levels | Change between baseline and completion of cannulation (2 hours later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paediatric Anaesthetic Emergence Delirium Score | An observational scale assessing delirium levels post surgery | Single measurement taken from observation over 15 minutes immediately following surgery | 
| State Trait Anxiety Inventory | A psychological scale measuring parental anxiety before and following the anaesthetic procedure for their child | Change between baseline and completion of cannulation (2 hours later) |