Preparing Kids for MRI Using VR

NCT07203716 | Not Yet Recruiting

• 1 other identifier: 176-2025
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety; Sedation; Child; Virtual Reality; MRI

Outcome Measures

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)

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

Secondary Outcomes (2)

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

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

• Total Scan Room Time

  During MRI session (room entry to room exit).

Study Arms (3)

Experimental - Home+Booster VR

EXPERIMENTAL

Home exposure 24-48 h pre-scan plus a brief on-site booster immediately before positioning.

Behavioral: Virtual Reality Orientation (Home+Booster)

Pre-Scan VR Only

EXPERIMENTAL

Single on-site VR exposure immediately before positioning.

Behavioral: Virtual Reality Orientation (Pre-Scan Only)

Usual Care

ACTIVE COMPARATOR

Standard pediatric MRI preparation without VR.

Other: Usual Care (No VR)

Interventions

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).

Experimental - Home+Booster VR

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.

Pre-Scan VR Only

Usual Care (No VR) OTHER

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

Usual Care

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Related Publications (5)

• van Spaendonck Z, Leeuwenburgh KP, Dremmen M, van Schuppen J, Starreveld D, Dierckx B, Legerstee JS. Comparing Smartphone Virtual Reality Exposure Preparation to Care as Usual in Children Aged 6 to 14 Years Undergoing Magnetic Resonance Imaging: Protocol for a Multicenter, Observer-Blinded, Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 24;12:e41080. doi: 10.2196/41080.

  PMID: 36692931 BACKGROUND

• Harned RK 2nd, Strain JD. MRI-compatible audio/visual system: impact on pediatric sedation. Pediatr Radiol. 2001 Apr;31(4):247-50. doi: 10.1007/s002470100426.

  PMID: 11321741 BACKGROUND

• Le May S, Genest C, Hung N, Francoeur M, Guingo E, Paquette J, Fortin O, Guay S. The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e30616. doi: 10.2196/30616.

  PMID: 35700000 BACKGROUND

• Stunden C, Stratton K, Zakani S, Jacob J. Comparing a Virtual Reality-Based Simulation App (VR-MRI) With a Standard Preparatory Manual and Child Life Program for Improving Success and Reducing Anxiety During Pediatric Medical Imaging: Randomized Clinical Trial. J Med Internet Res. 2021 Sep 22;23(9):e22942. doi: 10.2196/22942.

  PMID: 34550072 BACKGROUND

• Ashmore J, Di Pietro J, Williams K, Stokes E, Symons A, Smith M, Clegg L, McGrath C. A Free Virtual Reality Experience to Prepare Pediatric Patients for Magnetic Resonance Imaging: Cross-Sectional Questionnaire Study. JMIR Pediatr Parent. 2019 Apr 18;2(1):e11684. doi: 10.2196/11684.

  PMID: 31518319 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD - Pediatrician (Principal Investigator)

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 2, 2025
• Study Start: October 6, 2025
• Primary Completion: January 15, 2026
• Study Completion: March 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09