VR Based Simulation in the Preparation of Children for MRI - MRVR

NCT06132854 | Recruiting

• 1 other identifier: SE RKEB 202/2021
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to evaluate whether a virtual reality based preparation method can efficiently decrease the proportion of children requiring general anesthesia during MRI examinations. Participants will take part in a virtual reality environment resembling an MRI before their scheduled MRI examination. Researchers will compare these children to usual care and a booklet based preparation method to see if less children need anesthesia for completing the MRI examination.

Conditions

Children, Only; Anesthesia

Keywords

MRI; Pediatrics; anesthesia; virtual reality

Outcome Measures

Primary Outcomes (1)

• proportion of children requiring anesthesia

  proportion of children requiring any form of anesthesia or sedation during the MRI examination

  during the MRI examination, assessed directly after the MRI from anesthesiology documentation

Secondary Outcomes (6)

• fear

  assessed directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination

• mood

  directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination

• nervousness

  directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination

• familiarity

  directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination

• willingness to take part again

  no later than 4 hours after the MRI examination

Other Outcomes (9)

• fear of the parent

  directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination

• mood of the parent

  directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination

• nervousness of the parent

  directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination

Study Arms (3)

VR

EXPERIMENTAL

Participants in the VR group are immersed in a unique 360° VR experience specifically designed for this study. The custom made VR experience consists of two parts. In the first part, children find themselves in a simulated MRI room which resembles to the one they will be scanned. The second half of the VR experience introduces a mindfulness-ACT based meditation segment within the context of a space travel.

Other: VR

Booklet

ACTIVE COMPARATOR

Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations of the MRI examination room and about the procedure. This serves as a resource to familiarize them with the MRI procedure, address common concerns, and provide information about what to expect during the exam. The role of the booklet condition is to serve as an active control for our experimental condition. This condition also contains an interaction with the experimenter and increases familiarity through explanation and illustrations. However, it does not involve the immersive effect of the VR.

Other: Booklet

Usual care

NO INTERVENTION

In the usual care condition children are prepared by the healthcare staff through explanations, reframing, playing as per personal preference which is currently the standard of care in our departments.

Interventions

VR OTHER

The virtual environment is provided by the Oculus Quest 2 or 3 VR headset, providing a high-quality and immersive visual experience.

VR

Booklet OTHER

Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations of the MRI examination room and about the procedure.

Booklet

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed assent and parental informed consent to participate in the study.
• Stated willingness to participate in the intervention and to complete study questionnaires.
• Inpatient or outpatient at the Pediatric Center.
• Age 4-18 years
• Scheduled for MRI examination under anesthesia at the Semmelweis University.
• Fluent in Hungarian language

You may not qualify if:

• Severe visual impairment or hearing loss that would hinder the participation of the VR and booklet experience.
• In case of epilepsy, if the treating physician recommend against participation.
• Children with severe intellectual disability which would hinder participation in the VR group e.g. not able to follow simple instructions.
• Inpatients, if the treating physician indicates that the child is too unwell for the study.
• Face or cranial deformities, wounds on the face and head which would hinder wearing the VR headset.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Pediatric Center, Semmelweis University

Budapest, Budapest, 1094, Hungary

RECRUITING

Study Officials

• Klara Horvath, MD PhD

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klara Horvath, MD PhD

CONTACT

0036208259395; horvath.klara@gyerekklinika.com

Sandor Erdos, MD

CONTACT

036306821793; erdos.sandor96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants cannot be blinded due to the nature of the study. The radiologists, anesthesiology team, MRI staff and the second research assistant administering post-procedure questionnaires and coding anesthesiology data intended to be blinded, however, children may disclose their group by talking about their experience.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 15, 2023
• Study Start: November 7, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)