Rationale. Pre-procedural anxiety in pediatric MRI is a well-recognized driver of motion, repetition of sequences, longer scanner occupancy, and sedation exposure. Brief, developmentally tailored exposure using a 360° VR module is hypothesized to reduce anxiety and movement through familiarization with scanner sounds, spatial constraints, and behavioral expectations.
Design Overview. Single-center, three-arm randomized clinical trial with parallel assignment and allocation concealment. Participants with no prior MRI experience are randomized 1:1:1 to Home+Booster VR, Pre-Scan VR only, or Usual Care. Outcome assessment is masked to allocation. Analyses follow intention-to-treat; per-protocol summaries are planned as supportive.
Intervention Content and Delivery. The VR module (\~8-10 minutes) depicts arrival, positioning, acoustic noise, and the importance of remaining still. Narration and visuals are age-appropriate.
* Home+Booster VR: module viewed at home approximately 24-48 hours before MRI (re-view permitted), plus a brief on-site refresher immediately before positioning.
* Pre-Scan VR only: module viewed only on site immediately before positioning.
* Usual Care: standard institutional preparation without VR. Routine safety procedures and child-oriented coaching are applied uniformly across arms.
Adherence and Fidelity. Where available, platform logs capture timestamps and duration of module exposure (home and on-site). Staff document completion of on-site viewing and any technical issues. Periodic fidelity checks ensure consistent delivery.
Randomization, Masking, and Allocation Concealment. Randomization is performed via a concealed sequence (computer-generated permuted blocks). Allocation is revealed to staff immediately prior to preparation. Image-quality ratings are performed by a board-certified radiologist masked to allocation. Staff involved in VR delivery are not masked; contact with the assessor is minimized.
Safety Monitoring. VR is paused or discontinued for nausea, dizziness, or discomfort. Standard MRI safety screening is conducted per institutional policy. Adverse events related to VR exposure or MRI are recorded and reviewed by the study team; serious events are reported per institutional requirements.
Data Handling. Data are captured in secure, access-controlled case report forms with predefined range checks. Personally identifiable information is stored separately from analytic datasets. Quality control includes double-entry checks for a subset and automated logic checks.
Statistical Approach (brief). Descriptive statistics summarize baseline characteristics and feasibility metrics (e.g., adherence to the module). The primary endpoint (motion artifact score) is analyzed under intention-to-treat using appropriate ordinal or dichotomous models specified in the statistical analysis plan. Prespecified subgroup analyses examine age bands (5-7 vs 8-10). Multiplicity control procedures are detailed in the analysis plan. Missing data strategies are predefined and documented.
Timeline. Recruitment is planned to commence October 6, 2025. Enrollment and follow-up are expected to conclude within approximately three months, subject to scheduling logistics and scanner availability.
