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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02321657
Acronym
RELAX-A
Enrollment
100
Registered
2014-12-22
Start date
2015-03-31
Completion date
2015-09-30
Last updated
2015-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Brief 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.

Detailed 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.

Interventions

OTHERiPad 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

OTHERToys, books and games

Games, books and toys used to distract

Sponsors

Chelsea and Westminster NHS Foundation Trust
CollaboratorOTHER
Royal College of Music
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Yale Preoperative Anxiety ScaleChange between baseline and completion of cannulation (2 hours later)An observational scale assessing distress levels

Secondary

MeasureTime frameDescription
Paediatric Anaesthetic Emergence Delirium ScoreSingle measurement taken from observation over 15 minutes immediately following surgeryAn observational scale assessing delirium levels post surgery
State Trait Anxiety InventoryChange 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

MeasureTime frameDescription
Time to inductionDuration 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
Drugs costDrugs 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026