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Recruiting NCT06132854

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

◆ AI Clinical Summary

This study tests whether children can use virtual reality to practice what an MRI scan feels like before their real appointment. The goal is to help children feel less anxious during MRI so they won't need to be put to sleep.

Key Objective: This trial tests whether VR preparation can reduce the need for general anesthesia during MRI scans in children.

Who to Consider: Children who need an MRI scan and their parents should consider enrolling if they want to explore a non-medication approach to reducing anxiety during the procedure.

Trial Parameters

Condition Children, Only
Sponsor Semmelweis University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 288
Sex ALL
Min Age 4 Years
Max Age 18 Years
Start Date 2023-11-07
Completion 2025-12-31
Interventions
VRBooklet

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.

Eligibility Criteria

Inclusion Criteria: 1. Informed assent and parental informed consent to participate in the study. 2. Stated willingness to participate in the intervention and to complete study questionnaires. 3. Inpatient or outpatient at the Pediatric Center. 4. Age 4-18 years 5. Scheduled for MRI examination under anesthesia at the Semmelweis University. 6. Fluent in Hungarian language Exclusion Criteria: 1. Severe visual impairment or hearing loss that would hinder the participation of the VR and booklet experience. 2. In case of epilepsy, if the treating physician recommend against participation. 3. Children with severe intellectual disability which would hinder participation in the VR group e.g. not able to follow simple instructions. 4. Inpatients, if the treating physician indicates that the child is too unwell for the study. 5. Face or cranial deformities, wounds on the face and head which would hinder wearing the VR headset.

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