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

Anesthesia Clinical Trial

— MRVR  

Official title:

Efficacy of Virtual Reality Based Simulation in the Preparation of Children for Magnetic Resonance Imaging Examinations: a Randomized Clinical Trial (MRVR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06132854
• Other study ID #: SE RKEB 202/2021
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Semmelweis University
• Contact: Klara Horvath, MD PhD
• Phone: 0036208259395
• Email: horvath.klara[@]gyerekklinika.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Description: Our study investigates the efficacy of a custom-made virtual reality experience in the preparation of children for MRI examinations. We hypothesise that preparation with VR can significantly reduce the need for anesthesia in children during MRI examinations, or if anesthesia is needed less doses of anesthetics are required. Objectives: Primary Objective: To evaluate whether the VR based preparation decreases the need for anesthesia and sedation during MRI examinations. Secondary Objectives: To evaluate whether fear, mood, anxiety, familiarity with the MRI examination of the children and willingness to take part again change as a result of the intervention. Endpoints: Primary Endpoint: The need for any anesthetic or sedative medication during MRI examination. Secondary Endpoints: Visual analogue scales related to fear, mood and familiarity, willingness to take part in an MRI examination again. Study Population: 288 children aged 4-18 years who are in- or outpatients at the Pediatric Center of the Semmelweis University and are scheduled for MRI examination with anesthesia will be enrolled. Description of Sites/Facilities Enrolling Participants: The study takes place in the two Departments of the Pediatric Centre of the Semmelweis University Description of Study Intervention/Experimental Manipulation: Our research will be conducted as a three arm randomized controlled trial (VR, booklet, usual care). Participants in the VR condition are immersed in a unique 360° VR experience specifically designed for this study. Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations about the MRI examination. In the usual care condition children are prepared by the healthcare staff without using any specific equipment or standardized methods. Study Duration: 36 months Participant Duration: All participants need a single visit intervention to complete all study related tasks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Children, Only

Intervention

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

Locations

Country	Name	City	State
Hungary	Pediatric Center, Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fear of the parent	fear of the parent measured on a visual analogue scale, range 1-100, higher indicating increased fear	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Other	mood of the parent	mood of the parent measured on a visual analogue scale, scale range 1-100, higher indicating better mood	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Other	nervousness of the parent	nervousness of the parent measured on a visual analogue scale, scale range 1-100, higher increased nervousness	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Other	familiarity of the parent	familiarity of the parent with the MRI examination measured on a visual analogue scale, scale range 1-100, higher indicating increased familiarity with the MRI	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Other	fear of the child assessed by parent	fear of the child assessed by parent measured on a visual analogue scale, range 1-100, higher indicating increased fear	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Other	mood of the child assessed by parent	mood of the child assessed by parent measured on a visual analogue scale, scale range 1-100, higher indicating better mood	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Other	nervousness of the child assessed by parent	nervousness of the child assessed by parent measured on a visual analogue scale, scale range 1-100, higher increased nervousness	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Other	familiarity of the child assessed by parent	familiarity of the child with the MRI examination assessed by parent measured on a visual analogue scale, scale range 1-100, higher indicating increased familiarity with the MRI	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Other	propofol dose	Dose of propofol used per body weight and duration of MRI examination.	during the MRI examination, assessed from anesthesiology documentation 1 day after the MRI at the latest
Primary	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	fear	fear of the child measured on a visual analogue scale range 1-100, higher indicating increased fear	assessed directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Secondary	mood	mood of the child measured on a visual analogue scale, scale range 1-100, higher indicating better mood	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Secondary	nervousness	nervousness of the child measured on a visual analogue scale, scale range 1-100, higher increased nervousness	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Secondary	familiarity	familiarity of the child with the MRI examination measured on a visual analogue scale scale range 1-100, higher indicating increased familiarity with the MRI	directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
Secondary	willingness to take part again	willingness of the child to take part in a future MRI examination measured on a visual analogue scale, scale range 1-100, higher indicating more willingness taking part in a future MRI examination	no later than 4 hours after the MRI examination
Secondary	helpfulness	indication how much the child found the preparation method helpful, measured on a visual analogue scale, scale range 1-100, higher indicating the preparation method was more helpful	directly before the MRI examination