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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 5-18 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.

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

Conditions
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Children, Only, Anesthesia

Intervention / Treatment
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* Other: VR
* Other: Booklet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 5-18 years Scheduled for MRI examination under anesthesia at the Semmelweis University. Fluent in Hungarian language Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR<br>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<br>* The virtual environment is provided by the Oculus Quest 2 VR headset, providing a high-quality and immersive visual experience.<br>|
| Active Comparator: Booklet<br>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<br>* 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.<br>|
| No Intervention: Usual care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Pediatrics, anesthesia, virtual reality