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

Semmelweis University

Status: Enrolling

Conditions: Children, Only; Anesthesia

Treatments: Other: VR; Other: Booklet

Study type: Interventional

Funder types: Other

Identifiers

NCT06132854

SE RKEB 202/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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288 participants in 3 patient groups

VR

Experimental group

Description:

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.

Treatment:

Other: VR

Booklet

Active Comparator group

Description:

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.

Treatment:

Other: Booklet

Usual care

No Intervention group

Description:

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.