JMIR Publications

ABSTRACT

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 and reschedule 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 this intervention could help identify which children are more responsive to VR.

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 in children scheduled for an MRI (field test phase) and 3- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety in children undergoing an MRI (RCT).

Methods:

This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to initiate the development of a predictive algorithm for biofeedback solution requiring actual participants and to address the feasibility and acceptability of the VR intervention and research process. Following the field test, a randomized clinical trial 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 and fun simulation of the MRI environment. 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 and 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 (heart rate, skin conductance, hand temperature and muscle tension) and levels of satisfaction of healthcare professionals, parents, and participants will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05.

Results:

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.

Conclusions:

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 MRI. Clinical Trial: NCT04988516