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

Royal College of Music

Status: Completed

Conditions: Surgery

Treatments: Other: Toys, books and games; Other: iPad app containing art, music and games

Study type: Interventional

Funder types: Other

Identifiers

NCT02321657

RELAX2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

iPad app containing art, music and games

Experimental group

Description:

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.

Treatment:

Other: iPad app containing art, music and games

Toys, books and games

Active Comparator group

Description:

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.

Treatment:

Other: Toys, books and games