VR Based Simulation in the Preparation of Children for MRI - MRVR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorSemmelweis University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 4-18 years
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
VR
Other interventionThe virtual environment is provided by the Oculus Quest 2 or 3 VR headset, providing a high-quality and immersive visual experience.
Booklet
Other interventionChildren in the booklet condition will be prepared by using an educational booklet containing colorful illustrations of the MRI examination room and about the procedure.
Treatment groups
288 Participants
are divided into 3 treatment groupsGroup A: VRExperimental treatment 1 intervention
Group B: BookletActive comparator 1 intervention
Group C: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
proportion of children requiring anesthesia
proportion of children requiring any form of anesthesia or sedation during the MRI examination
Time frame
during the MRI examination, assessed directly after the MRI from anesthesiology documentationSecondary outcomes
1
fear
fear of the child measured on a visual analogue scale range 1-100, higher indicating increased fear
Time frame
assessed directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination2
mood
mood of the child measured on a visual analogue scale, scale range 1-100, higher indicating better mood
Time frame
directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination3
nervousness
nervousness of the child measured on a visual analogue scale, scale range 1-100, higher increased nervousness
Time frame
directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination4
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
Time frame
directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examinationOther outcomes
1
fear of the parent
fear of the parent measured on a visual analogue scale, range 1-100, higher indicating increased fear
Time frame
directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination2
mood of the parent
mood of the parent measured on a visual analogue scale, scale range 1-100, higher indicating better mood
Time frame
directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination3
nervousness of the parent
nervousness of the parent measured on a visual analogue scale, scale range 1-100, higher increased nervousness
Time frame
directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination4
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
Time frame
directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examinationSponsors and contacts
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Source ClinicalTrials.gov