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Completed

NCT Number: NCT02321657

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

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.

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Key information

Conditions

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Performance Science, Royal College of Music, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iPad app containing art, music and games

Other

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

Toys, books and games

Other

Games, books and toys used to distract

Primary outcomes

  1. Modified Yale Preoperative Anxiety Scale

    Time frame: Change between baseline and completion of cannulation (2 hours later)

    An observational scale assessing distress levels

Secondary outcomes

  1. Paediatric Anaesthetic Emergence Delirium Score

    Time frame: Single measurement taken from observation over 15 minutes immediately following surgery

    An observational scale assessing delirium levels post surgery

  2. State Trait Anxiety Inventory

    Time frame: Change between baseline and completion of cannulation (2 hours later)

    A psychological scale measuring parental anxiety before and following the anaesthetic procedure for their child

Other outcomes

  1. Time to induction

    Time frame: Duration of anaesthetics timed (from entering the anaesthetics room to successful anaesthetisation of child (estimated 3-30mins in the room)

    Time taken to cannulate and anaesthetise a child

  2. Drugs cost

    Time frame: Drugs used from the time the child enters the anaesthetics room to successful anaesthetisation (estimated 3-30mins in the room)

    Cost of induction agents during anaesthetic procedure

Sponsors and collaborators

Lead sponsor

Royal College of Music

Other

Collaborators

  • Chelsea and Westminster NHS Foundation Trust

Registry information

Acronym: RELAX-A

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 22, 2014
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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