Preparing Kids for MRI Using VR

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorHaseki Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Orientation (Home+Booster)

    Behavioral

    Age-appropriate 360° VR module (\~8-10 min) showing MRI room, sounds, positioning, and the importance of keeping still; viewed at home 24-48 h pre-scan on a smartphone/VR viewer (or flat 360° if no headset), plus a brief booster view on site immediately before positioning (\~3-5 min refresher).

  • Virtual Reality Orientation (Pre-Scan Only)

    Behavioral

    The same 360° VR module (\~8-10 min) viewed once on site in the MRI area immediately before positioning; no home exposure.

  • Usual Care (No VR)

    Other intervention

    Standard institutional pediatric MRI preparation (verbal explanation, hearing protection demo, child-friendly coaching) without VR.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Experimental - Home+Booster VRExperimental treatment 1 intervention
Group B: Pre-Scan VR OnlyExperimental treatment 1 intervention
Group C: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Radiologist-Rated MRI Motion Artifact (ordinal score)

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)

Time frame
During MRI session; assessment completed within 24 hours of image acquisition.

Secondary outcomes

1

Diagnostic-Quality MRI Without Repeat or Sedation (yes/no)

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 (%)

Time frame
At completion of MRI session; determination recorded within 24 hours of image acquisition.
2

Total Scan Room Time

Time from room entry to room exit during the MRI session, including positioning and image acquisition. Unit of Measure: minutes

Time frame
During MRI session (room entry to room exit).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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