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

Surgery Clinical Trial

— RELAX-A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321657
• Other study ID #: RELAX2015
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: October 26, 2015
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Royal College of Music
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• iPad app containing art, music and games
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
Games, books and toys used to distract

Locations

Country	Name	City	State
United Kingdom	Centre for Performance Science, Royal College of Music	London
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal College of Music	Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to induction	Time taken to cannulate and anaesthetise a child	Duration of anaesthetics timed (from entering the anaesthetics room to successful anaesthetisation of child (estimated 3-30mins in the room)	No
Other	Drugs cost	Cost of induction agents during anaesthetic procedure	Drugs used from the time the child enters the anaesthetics room to successful anaesthetisation (estimated 3-30mins in the room)	No
Primary	Modified Yale Preoperative Anxiety Scale	An observational scale assessing distress levels	Change between baseline and completion of cannulation (2 hours later)	No
Secondary	Paediatric Anaesthetic Emergence Delirium Score	An observational scale assessing delirium levels post surgery	Single measurement taken from observation over 15 minutes immediately following surgery	No
Secondary	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)	No