Children, OnlyMRVRNCT06132854
VR Based Simulation in the Preparation of Children for MRI - MRVR
A study testing VR and Booklet in people with Children, Only and Anesthesia, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Children, Only, Anesthesia
- What is being tested?
- VR and Booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteHungary
- Study dates
- 7 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Scheduled for MRI examination under anesthesia at the Semmelweis University.
- Fluent in Hungarian language
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Pediatric Center, Semmelweis University
Budapest, Budapest, 1094
Klara Horvath, MD PhD, 0036208259395, horvath.klara@gyerekklinika.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Children, Only, Anesthesia
- Being tested
- VR, Booklet
- Keywords
- MRI, Pediatrics, anesthesia, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VROther
The virtual environment is provided by the Oculus Quest 2 or 3 VR headset, providing a high-quality and immersive visual experience.
BookletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VR | Experimental | 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. Receives: Other: VR |
| Booklet | Active comparator | 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. Receives: Other: Booklet |
| Usual care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
proportion of children requiring anesthesia
proportion of children requiring any form of anesthesia or sedation during the MRI examination
Measured: during the MRI examination, assessed directly after the MRI from anesthesiology documentation
Secondary outcomes (6)
fear
fear of the child measured on a visual analogue scale range 1-100, higher indicating increased fear
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: directly before the MRI examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start7 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, OnlyStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Horváth Klára, Semmelweis University
- Investigators
- Klara Horvath, MD PhD, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132854
- Sponsor's protocol ID
- SE RKEB 202/2021
- Acronym
- MRVR
- Status last verified
- Apr 2026
- First submitted
- 6 Nov 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality Based Simulation in the Preparation of Children for Magnetic Resonance Imaging Examinations: a Randomized Clinical Trial (MRVR)
- ClinicalTrials.gov ID
- NCT06132854
- Acronym / sponsor ID
- MRVR / SE RKEB 202/2021
- Conditions
- Children, Only, Anesthesia
- Keywords
- MRI, Pediatrics, anesthesia, virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR | Experimental | Other: VRParticipants 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. |
| Booklet | Active comparator | Other: BookletChildren 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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
- Scheduled for MRI examination under anesthesia at the Semmelweis University.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRThe virtual environment is provided by the Oculus Quest 2 or 3 VR headset, providing a high-quality and immersive visual experience. | Other | VR |
| BookletChildren in the booklet condition will be prepared by using an educational booklet containing colorful illustrations of the MRI examination room and about the procedure. | Other | Booklet |
Primary outcome
proportion of children requiring anesthesia
Time frame: during the MRI examination, assessed directly after the MRI from anesthesiology documentation
proportion of children requiring any form of anesthesia or sedation during the MRI examination
6 secondary outcomes
fear
Time frame: assessed directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
mood
Time frame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
nervousness
Time frame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
familiarity
Time frame: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination
willingness to take part again
Time frame: no later than 4 hours after the MRI examination
helpfulness
Time frame: directly before the MRI examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klara Horvath, MD PhD principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR and Booklet in people with Children, Only and Anesthesia, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klara Horvath, MD PhD (0036208259395, horvath.klara@gyerekklinika.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of children requiring anesthesia (time frame: during the MRI examination, assessed directly after the MRI from anesthesiology documentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.