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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Children, Only
• Intervention / Treatment: Other: Booklet; Other: VR

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klara Horvath, MD PhD; Phone Number: 0036208259395; Email: horvath.klara@gyerekklinika.com
• Study Contact Backup: Name: Sandor Erdos, MD; Phone Number: 036306821793; Email: erdos.sandor96@gmail.com

Study Locations

• Hungary
  • Budapest, Hungary, 1094
    • Recruiting
    • Pediatric Center, Semmelweis University
    • Contact: Klara Horvath, MD PhD; Phone Number: 0036208259395; Email: horvath.klara@gyerekklinika.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR; 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; The virtual environment is provided by the Oculus Quest 2 or 3 VR headset, providing a high-quality and immersive visual experience.
Active Comparator: 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. 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; 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.
No Intervention: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: Klara Horvath, MD PhD, Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MRI; anesthesia; Pediatrics; virtual reality
• Other Study ID Numbers: SE RKEB 202/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No