Clinical trial NCT06132854: VR Based Simulation in the Preparation of Children for MRI - MRVR
Official title: Efficacy of Virtual Reality Based Simulation in the Preparation of Children for Magnetic Resonance Imaging Examinations: a Randomized Clinical Trial (MRVR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children, Only
Anesthesia
Keywords: MRI
Pediatrics
anesthesia
virtual reality
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 288
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: proportion of children requiring anesthesia
timeFrame: during the MRI examination, assessed directly after the MRI from anesthesiology documentation
Secondary outcomes:
measure: fear
timeFrame: assessed directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: mood
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: nervousness
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: familiarity
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: willingness to take part again
timeFrame: no later than 4 hours after the MRI examination
measure: helpfulness
timeFrame: directly before the MRI examination
Other outcomes:
measure: fear of the parent
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: mood of the parent
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: nervousness of the parent
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: familiarity of the parent
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: fear of the child assessed by parent
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: mood of the child assessed by parent
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: nervousness of the child assessed by parent
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: familiarity of the child assessed by parent
timeFrame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
measure: propofol dose
timeFrame: during the MRI examination, assessed from anesthesiology documentation 1 day after the MRI at the latest
Locations:
city: Budapest
country: Hungary
facility: Pediatric Center, Semmelweis University
Study officials:
affiliation: Semmelweis University
name: Klara Horvath, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: