NCT02321657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

December 8, 2014

Last Update Submit

October 26, 2015

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Modified Yale Preoperative Anxiety Scale

    An observational scale assessing distress levels

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

Secondary Outcomes (2)

  • Paediatric Anaesthetic Emergence Delirium Score

    Single measurement taken from observation over 15 minutes immediately following surgery

  • State Trait Anxiety Inventory

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

Other Outcomes (2)

  • Time to induction

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

  • Drugs cost

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

Study Arms (2)

iPad app containing art, music and games

EXPERIMENTAL

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

Toys, books and games

ACTIVE COMPARATOR

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

Interventions

iPad app containing art, music and gamesOTHER

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

iPad app containing art, music and games
Toys, books and gamesOTHER

Games, books and toys used to distract

Toys, books and games

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children ages 2 -12 years
  • requiring general anaesthesia
  • ASA assessment of fitness for surgery score 1 - 3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chelsea and Westminster Hospital

London, SW10 9HS, United Kingdom

Location

Centre for Performance Science, Royal College of Music

London, SW7 2BS, United Kingdom

Location

Study Officials

  • Peter Brooks

    Chelsea and Westminster NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 22, 2014

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations

GB(2)