NCT04988516

Virtual Reality Distraction for Anxiety (VR-IMAGINE)

Status unknown NA Last updated 18 November 2023

What this trial tests

NA trial testing Virtual reality in Magnetic Resonance Imaging in 98 participants. Status unknown.

Timeline

27 May 2022

Primary endpoint
30 August 2024

30 May 2025

Quick facts

Lead sponsor	St. Justine's Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	27 May 2022
Primary completion	30 August 2024
Estimated completion	30 May 2025
Sites	1 location across Canada

Drugs / interventions tested

• Virtual reality
• Standard protocol — full drug profile →

Conditions studied

• Magnetic Resonance Imaging — all drugs for Magnetic Resonance Imaging →
• Pediatric — all drugs for Pediatric →
• Virtual Reality — all drugs for Virtual Reality →
• Anxiety — all drugs for Anxiety →

Sponsor

St. Justine's Hospital

Who can join

Adults 7 to 17, any sex, with Magnetic Resonance Imaging or Pediatric. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial.
   Le May S, Genest C, Hung N, Francoeur M, et al · · 2022 · cited 5× · PMID 35700000 · DOI 10.2196/30616