Recruiting

VR-IMAGINE

Sponsor:

St. Justine's Hospital

Code:

NCT05909878

Conditions

Magnetic Resonance Imaging

Pediatric

Virtual Reality

Anxiety

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Standard Protocol

Study Details

Brief 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 immersive virtual reality (IVR) on anxiety in children scheduled for an MRI.

Objectives:

The aims of this study are two-fold: 1- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 2- 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 address the feasibility and acceptability of the use of virtual reality. 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 CHU Sainte-Justine's, 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, measures of 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 biomarkers of anxiety such as alpha-amylase and other markers such as heart rate and head deviation will also be measured. 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.

Discussion:

Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. It 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

Study ID

NCT05909878

Start date

May 27, 2022

Status verified date

Dec, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • aged from 7 to 17 years old
  • required to undergo MRI
  • accompanied by a consenting parent or legal guardian who can understand, read and write either French or English

Exclusion Criteria:

  • have a diagnosis of epilepsy or any other condition preventing them from playing a virtual reality game
  • cannot stand a sitting or semi-upright sitting position (Fowler's position) during the preparation as the VR gear requires an angle of at least 30 degrees for head-tracking

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality Distraction

Use of Virtual Reality (VR) before the MRI.

active comparator: Standard Treatment

Standard Treatment used at the radiology department.

Interventions

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.

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. Specifically at the hospital (HSJ), standard care also includes access to a television mounted near the MRI playing videos.The research nurse will be able to complete any information should they find it incomplete or substandard.

Primary outcome measure

  • Level of state-trait anxiety [ Time Frame: Change from Baseline (T0) at 15 minutes (T1) and at 30 minutes (T2) ]
  • Level of anxiety [ Time Frame: Change from Baseline (T0) at 15 minutes (T1) and at 45 minutes (T2) ]

Central Contacts and Locations

Central contacts

Sylvie Le May, PhD

5143454931sylvie.lemay@umontreal.ca

Locations

St. Justine's Hospital

Recruiting

Montréal, Quebec, Canada, H1T 3C5

Contacts

Sylvie Le May, PhD

5143454931sylvie.lemay@umontreal.ca

Principal Investigator:

Sylvie Le May, PhD

More Information

Sponsor

St. Justine's Hospital

Last update posted

Dec 11, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2023-12-11.