[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526293":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":61,"collaborators":24,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":48,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Semmelweis University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"VR","EXPERIMENTAL","Participants in the VR group are immersed in a unique 360° VR experience specifically designed for this study.\n\nThe 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.\n\nThe second half of the VR experience introduces a mindfulness-ACT based meditation segment within the context of a space travel.",[13],"Other: VR",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Booklet",{"label":21,"type":22,"description":23,"interventionNames":24},"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.",null,[26,29],{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":24},"The virtual environment is provided by the Oculus Quest 2 or 3 VR headset, providing a high-quality and immersive visual experience.",[9],{"type":6,"name":15,"description":30,"armGroupLabels":31,"otherNames":24},"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.",[15],[33],{"name":34,"affiliation":5,"role":35},"Klara Horvath, MD PhD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":24,"email":40},"CONTACT","0036208259395","horvath.klara@gyerekklinika.com",{"name":42,"role":38,"phone":43,"phoneExt":24,"email":44},"Sandor Erdos, MD","036306821793","erdos.sandor96@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Pediatric Center, Semmelweis University","RECRUITING","Budapest","1094","Hungary","HU",{"type":54,"coordinates":55},"Point",[56,57],19.04045,47.49835,{"lat":57,"lon":56},[60],{"name":34,"role":38,"phone":39,"phoneExt":24,"email":40},{"type":35,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Dr. Horváth Klára","assistant professor","100526293","vr-based-simulation-in-the-preparation-of-children-for-mri---mrvr-100526293",false,"NCT06132854","VR Based Simulation in the Preparation of Children for MRI - MRVR","Efficacy of Virtual Reality Based Simulation in the Preparation of Children for Magnetic Resonance Imaging Examinations: a Randomized Clinical Trial (MRVR)","MRVR","Inclusion Criteria:\n\n1. Informed assent and parental informed consent to participate in the study.\n2. Stated willingness to participate in the intervention and to complete study questionnaires.\n3. Inpatient or outpatient at the Pediatric Center.\n4. Age 4-18 years\n5. Scheduled for MRI examination under anesthesia at the Semmelweis University.\n6. Fluent in Hungarian language\n\nExclusion Criteria:\n\n1. Severe visual impairment or hearing loss that would hinder the participation of the VR and booklet experience.\n2. In case of epilepsy, if the treating physician recommend against participation.\n3. Children with severe intellectual disability which would hinder participation in the VR group e.g. not able to follow simple instructions.\n4. Inpatients, if the treating physician indicates that the child is too unwell for the study.\n5. Face or cranial deformities, wounds on the face and head which would hinder wearing the VR headset.","ALL","4 Years","18 Years",{"count":76,"type":77},288,"ESTIMATED","INTERVENTIONAL",[80],"NA","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.\n\nParticipants will take part in a virtual reality environment resembling an MRI before their scheduled MRI examination.\n\nResearchers 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.",[83,84],"Children, Only","Anesthesia",[86,87,88,89],"MRI","Pediatrics","anesthesia","virtual reality","2026-04-22",{"date":92,"type":93},"2026-04-28","ACTUAL",{"date":95,"type":93},"2023-11-07",{"date":97,"type":77},"2026-12-31",{"name":5,"class":6},1]