Clinical trial NCT02321657: RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia
Official title: RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Royal College of Music
Sponsor class: OTHER
Collaborators: name: Chelsea and Westminster NHS Foundation Trust
First posted: 2014-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Yale Preoperative Anxiety Scale
timeFrame: Change between baseline and completion of cannulation (2 hours later)
Secondary outcomes:
measure: Paediatric Anaesthetic Emergence Delirium Score
timeFrame: Single measurement taken from observation over 15 minutes immediately following surgery
measure: State Trait Anxiety Inventory
timeFrame: Change between baseline and completion of cannulation (2 hours later)
Other outcomes:
measure: Time to induction
timeFrame: Duration of anaesthetics timed (from entering the anaesthetics room to successful anaesthetisation of child (estimated 3-30mins in the room)
measure: Drugs cost
timeFrame: Drugs used from the time the child enters the anaesthetics room to successful anaesthetisation (estimated 3-30mins in the room)
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: Centre for Performance Science, Royal College of Music
Study officials:
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Peter Brooks
role: PRINCIPAL_INVESTIGATOR
References: