Preparing Kids for MRI Using VR
- Conditions
- AnxietySedationChildVirtual RealityMRI
- Registration Number
- NCT07203716
- Lead Sponsor
- Haseki Training and Research Hospital
- Brief Summary
Children frequently exhibit pre-MRI anxiety that can cause motion, repeated sequences, prolonged room time, and exposure to sedation. Orientation with Virtual Reality (VR) may reduce anxiety by familiarizing children with the scanner environment and expected sensations. This single-center, three-arm randomized clinical trial evaluates whether (1) Home+Booster VR (an age-appropriate 360° VR module at home \~24-48 hours before MRI plus a brief on-site refresher immediately before positioning), (2) Pre-Scan VR only (same module viewed on site immediately before positioning), or (3) Usual Care without VR improves MRI image quality and tolerance in children undergoing their first-ever MRI.
Eligible participants are children scheduled for clinically indicated, non-emergent MRI with no prior MRI experience. Major exclusions comprise MRI contraindications; contraindications to VR use (e.g., uncontrolled epilepsy or severe motion sickness); uncorrected severe visual/hearing impairment precluding VR viewing; and inability to provide assent/consent. After consent/assent, participants are randomized 1:1:1 to one of three arms. Anticipated enrollment is \~150 total (\~50 per arm; up to 60 per arm if feasible). All arms receive routine safety procedures and child-oriented coaching per institutional practice. The VR module (\~8-10 minutes) provides a 360° walkthrough of the MRI process (sounds, positioning, keeping still) with child-focused narration. Adherence (timestamps/duration) is recorded where applicable.
The primary outcome is motion artifact rated on a predefined ordinal scale by a board-certified radiologist masked to allocation; the proportion achieving diagnostic quality without repeat/sedation is also reported. Key secondary outcomes include sedation requirement, number of repeated sequences, total scan room time, scan completion without interruption, and change in child anxiety (mYPAS-SF). Additional prespecified measures include comfort/calmness Likert scales, Wong-Baker FACES pain, CEMS during scan, parent state anxiety, satisfaction VAS, physiologic vitals (heart rate, blood pressure, SpO₂) at defined peri-scan time points, observed crying and movement durations, and total scan duration. The trial uses parallel assignment with allocation concealment and masked outcome assessment. Analyses follow intention-to-treat with prespecified subgroup exploration by age bands (5-7 vs 8-10). Recruitment is planned for October 6, 2025; primary completion is expected within approximately three months.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Children 5 to 10 years old (inclusive).
- First-ever MRI for a clinically indicated, non-emergent examination (outpatient or elective inpatient).
- Ability to view the age-appropriate 360° VR module (head-mounted viewer or flat 360° on screen) with basic comprehension of instructions (child and/or caregiver in Turkish).
- Parental/guardian informed consent and child assent per age/competence.
- Standard MRI safety screening passed; institutional rescue sedation policies remain available if clinically required.
- MRI contraindications (e.g., non-MR-conditional implants, unsafe metallic foreign bodies).
- Pre-planned sedation or general anesthesia irrespective of behavior (clinician decision made prior to randomization).
- Conditions contraindicating VR exposure (e.g., uncontrolled epilepsy, severe motion sickness/vertigo causing intolerance).
- Severe uncorrected visual or hearing impairment precluding module viewing or instruction adherence.
- Emergent/urgent MRI where study procedures could delay care.
- Neurodevelopmental or behavioral conditions that render still positioning entirely unfeasible despite standard coaching (investigator judgment).
- Prior participation in this trial (no re-enrollment).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Radiologist-Rated MRI Motion Artifact (ordinal score) During MRI session; assessment completed within 24 hours of image acquisition. Motion artifact rated on a pre-specified 4-point ordinal scale per exam by a board-certified radiologist masked to allocation (0 = none; 1 = mild/not affecting diagnostic utility; 2 = moderate/partially limiting; 3 = severe/non-diagnostic). Inter-rater agreement (if applicable) will be summarized separately.
Unit of Measure: score (0-3)
- Secondary Outcome Measures
Name Time Method Diagnostic-Quality MRI Without Repeat or Sedation (yes/no) At completion of MRI session; determination recorded within 24 hours of image acquisition. Proportion of exams achieving diagnostic-quality images without repeated sequences and without sedation, based on pre-specified radiology/report criteria; ratings performed masked to allocation.
Unit of Measure: percent (%)Total Scan Room Time During MRI session (room entry to room exit). Time from room entry to room exit during the MRI session, including positioning and image acquisition.
Unit of Measure: minutes