Comparing virtual reality-based simulation, booklet-based and standard preparation methods for pediatric magnetic resonance imaging (MR-VR): study protocol for a randomized clinical trial

Abstract MRI examinations frequently induce considerable distress and anxiety in both children and their parents. This unease can result in patient movement, compromising image quality, or hindering the execution of the examination. Consequently, general anesthesia is commonly employed during pediatric MRI procedures. However, research indicates that adequate preparation can diminish the necessity for anesthesia, thereby reducing risks, costs, and examination duration. To address this, we have developed a custom virtual reality experience that integrates familiarization with the examination room alongside a gamified space mission infused with elements of mindfulness and acceptance and commitment therapy. Our ongoing study aims to assess whether this experience can decrease the need for anesthesia and improve psychological variables (children’s fear, nervousness, mood, and familiarity) in children aged 4–18 years undergoing MRI scans. The study is structured as a three-arm randomized controlled trial (VR, educational booklet, passive control), aiming to enroll 96 patients per arm, totaling 288 patients. Data collection commenced in November 2023 and we anticipate to reach our target by December 2025. The outcomes of this research hold significant potential to transform pediatric healthcare by reducing anesthesia reliance. This reduction could yield cost savings, decrease the requirement for specialized equipment and trained personnel, and improve the overall experience for children, their families, and healthcare providers. The trial was registered on clinicaltrials.gov under the identification number NCT06132854 on 11/06/2023, and modified on 26/02/2024.