LITTLE JOURNEY TRIAL
Research type
Research Study
Full title
An acceptability and feasibility trial: Can virtual reality prepare children for ambulatory surgery?
IRAS ID
223644
Contact name
Ramani Moonesinghe
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
0 years, 3 months, 30 days
Research summary
Having any procedure or operation is a daunting experience, especially as a child. Anxiety begins well before arriving in hospital and is exacerbated by new, unfamiliar environments and people. High anxiety levels are linked with distress on wakening from surgery and developing new dysfunctional behaviour after discharge from hospital, such as separation anxiety, bed wetting or nightmares. This dysfunctional behaviour is ongoing in 50% of children at two-weeks after discharge, continuing in 7-12% of patients at 1 year – equating to approximately 50,000 children.
This application is to ascertain the acceptability of Little Journey preparation tool, a novel intervention for preparing children for an operation using virtual reality. It also assesses the feasibility of the randomised controlled trial protocol through completion of a pilot trial. This will provide data to assist with the sample size calculation and highlight any limitations in the study design.
Children will be provided with a build-your-own virtual reality headset to use with our 360-degree-hospital environments; enabling them to explore and familiarise with the areas they will see during their hospital journey, such as the ward, anaesthetic room and recovery department. If they look at a specific object or person while exploring each area such as a nurse, facemask or observation machine, audio-visual information will appear explaining what they do and how it might feel.
Phase 1: A pilot and feasibility trial assessing the randomised controlled trial protocol design. A total of 20 children will be randomly assigned to either the standard practise arm or the intervention arm using our Virtual reality preparatory programme.
Phase 2: Assessing the acceptability and usability of our virtual reality preparation platform. This phase assesses the usability and acceptability of the preparatory tool through completion of a bespoke questionnaire by parents whose children are allocated to the intervention arm.
REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/0959
Date of REC Opinion
29 Jun 2017
REC opinion
Further Information Favourable Opinion