Virtual Reality Distraction for Anxiety (VR-IMAGINE)

Summary

Background:

Magnetic resonance imaging (MRI) has been known for almost forty years to generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI to be repeated with sedation. Very few studies seemed to have looked at the effect of virtual reality (VR) on anxiety in children scheduled for an MRI and how to identify which children are more responsive.

Objective:

The aims of this study are three-fold: 1- to develop an algorithm of predictability based on biofeedback; 2- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 3- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety during MRIs.

Methods:

This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to develop a predictive algorithm for biofeedback solution and to address the feasibility and acceptability of the research. Following the field test, a RCT will be completed using a parallel design with two groups: 1) experimental group (pre-procedural IVR game preparation), 2) usual care group (standard care as per radiology department's protocol) in an equal ratio of 49 participants per group for a total of 98 participants. Recruitment will be done at CIUSSS de l'Est de l'Île de Montréal, Quebec, Canada. The experimental group will receive a pre-procedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI. Participants will complete a questionnaire to assess the acceptability, feasibility and incidence of side effects related to the intervention and the biofeedback device. Data collected will include socio-demographic, clinical characteristics and measures of procedure related-anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (STAIC-F) and the Child Fear Scale (CFS, 0-4). Physiological signs will be noted and include heart rate, skin conductance, hand temperature and muscle tension. Measures of healthcare professionals, parents, and participants' level of satisfaction will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05.

Conclusions:

Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. The biofeedback will help predict which children are more responsive to this type of intervention. This study will guide future medical practice by providing evidence-based knowledge on a non-pharmacological therapeutic modality for anxiety management in children scheduled for an MRI.

Conditions

• Magnetic Resonance Imaging
• Pediatric
• Virtual Reality
• Anxiety

Interventions

DEVICE

Virtual reality

The pre-procedural IVR game preparation (IMAGINE) was developed by Paperplane Therapeutics® (intervention development team). IMAGINE is an immersive virtual reality simulation aiming to reduce the anxiety and phobic reactions of young patients and to better prepare them for this exam. Since the game is a preparation, it is a no success game and is independent of the ability and previous experience of the child with video games. It offers an immersive and fun simulation that aims to desensitize young patients to MRI and transform an anxiety-inducing experience into a fun play session. The participant will learn about the main principles of magnetic resonance imaging and experience a very realistic simulation of the MRI exam. This will allow children to prepare for the MRI scanner by enabling them to experience the process of undergoing an MRI exam beforehand.

OTHER

Standard protocol

The usual care group will only receive the standard preparation, which comprises of an explanation of the MRI procedure given by the radiology technician as per the radiology department's protocol. The research nurse will be able to complete any information should they find it incomplete or substandard.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital

  collaborator OTHER

• St. Justine's Hospital

  lead OTHER

Principal Investigators

• Sylvie Le May, PhD · Research Centre CHU Sainte-Justine

• Christine Genest, PhD · Research Centre IUSMM

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-27

Primary Completion

2024-08-30

Completion

2025-05-30

Countries

• Canada

Study Locations