NCT06132854 VR Based Simulation in the Preparation of Children for MRI - MRVR
| NCT ID | NCT06132854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Semmelweis University |
| Condition | Children, Only |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2023-11-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2023-11-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Klara Horvath, MD PhD
PRINCIPAL INVESTIGATOR
Semmelweis University
Frequently Asked Questions
Who can join the NCT06132854 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Children, Only. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06132854 currently recruiting?
Yes, NCT06132854 is actively recruiting participants. Contact the research team at horvath.klara@gyerekklinika.com for enrollment information.
Where is the NCT06132854 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT06132854 clinical trial?
NCT06132854 is sponsored by Semmelweis University. The principal investigator is Klara Horvath, MD PhD at Semmelweis University. The trial plans to enroll 288 participants.