Virtual Reality Game Preparation for Management of Anxiety in Children Scheduled for a Magnetic Resonance Imaging (IMAGINE): A Randomized Controlled Trial.

OBJECTIVES: To evaluate the feasibility and acceptability of using a preprocedural immersive virtual reality (VR) game to manage anxiety in children scheduled for a magnetic resonance imaging (MRI) test and to assess its efficacy in reducing preprocedural anxiety before the MRI. METHODS: This randomized controlled trial included 96 children scheduled for an MRI and randomly assigned to an experimental (VR) or a control group (standard care). Outcomes measured included anxiety (French State-Trait Anxiety Inventory for Children [STAIC-F]), fear (Child Fear Scale [CFS]), physiological stress (salivary alpha-amylase [SAA]), and feasibility and acceptability measures. Outcomes were analyzed using ANCOVA and nonparametric tests. RESULTS: Mean difference on the STAIC-F scores was significantly higher in the experimental group (p = 0.011). There was no significant difference between the experimental and control groups on the CFS, 1.4 ± 0.8 versus 1.3 ± 0.7; F(6, 81) = 1.24, p = 0.297, and neither between groups on the mean difference of the log-transformed SAA levels (-0.11 ± 0.58 vs. 0.20 ± 1.04; p = 0.10), respectively. Children's and parents' satisfaction levels with VR were 8.43/10 (standard deviation [SD] = 2.05) and 9.17/10 (SD = 1.27), respectively. CONCLUSION: Although VR was feasible and acceptable, with high satisfaction among both parents and children, VR game preparation did not significantly reduce MRI-related anxiety or fear. Minimal side effects and positive engagement suggest VR remains a promising adjunct for MRI preparation, highlighting the need for further refinement of VR content tailored to age and clinical context to enhance its efficacy in managing anxiety.