[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608604":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":31,"locations":31,"responsibleParty":40,"collaborators":31,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":31,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":31,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":31,"overallStatus":67,"whyStopped":31,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":31},{"fullName":5,"class":6},"Haseki Training and Research Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental - Home+Booster VR","EXPERIMENTAL","Home exposure 24-48 h pre-scan plus a brief on-site booster immediately before positioning.",[13],"Behavioral: Virtual Reality Orientation (Home+Booster)",{"label":15,"type":10,"description":16,"interventionNames":17},"Pre-Scan VR Only","Single on-site VR exposure immediately before positioning.",[18],"Behavioral: Virtual Reality Orientation (Pre-Scan Only)",{"label":20,"type":21,"description":22,"interventionNames":23},"Usual Care","ACTIVE_COMPARATOR","Standard pediatric MRI preparation without VR.",[24],"Other: Usual Care (No VR)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Virtual Reality Orientation (Home+Booster)","Age-appropriate 360° VR module (\\~8-10 min) showing MRI room, sounds, positioning, and the importance of keeping still; viewed at home 24-48 h pre-scan on a smartphone\u002FVR viewer (or flat 360° if no headset), plus a brief booster view on site immediately before positioning (\\~3-5 min refresher).",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Virtual Reality Orientation (Pre-Scan Only)","The same 360° VR module (\\~8-10 min) viewed once on site in the MRI area immediately before positioning; no home exposure.",[15],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Usual Care (No VR)","Standard institutional pediatric MRI preparation (verbal explanation, hearing protection demo, child-friendly coaching) without VR.",[20],{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Berker Okay","MD - Pediatrician (Principal Investigator)","100608604","preparing-kids-for-mri-using-vr-100608604",false,"NCT07203716","Preparing Kids for MRI Using VR","Effect of Home-Based and Immediate Pre-Scan Virtual Reality Orientation on Motion Artifacts and Sedation Need in Pediatric MRI: A Three-Arm Randomized Controlled Trial","Inclusion Criteria:\n\n* Children 5 to 10 years old (inclusive).\n* First-ever MRI for a clinically indicated, non-emergent examination (outpatient or elective inpatient).\n* Ability to view the age-appropriate 360° VR module (head-mounted viewer or flat 360° on screen) with basic comprehension of instructions (child and\u002For caregiver in Turkish).\n* Parental\u002Fguardian informed consent and child assent per age\u002Fcompetence.\n* Standard MRI safety screening passed; institutional rescue sedation policies remain available if clinically required.\n\nExclusion Criteria:\n\n* MRI contraindications (e.g., non-MR-conditional implants, unsafe metallic foreign bodies).\n* Pre-planned sedation or general anesthesia irrespective of behavior (clinician decision made prior to randomization).\n* Conditions contraindicating VR exposure (e.g., uncontrolled epilepsy, severe motion sickness\u002Fvertigo causing intolerance).\n* Severe uncorrected visual or hearing impairment precluding module viewing or instruction adherence.\n* Emergent\u002Furgent MRI where study procedures could delay care.\n* Neurodevelopmental or behavioral conditions that render still positioning entirely unfeasible despite standard coaching (investigator judgment).\n* Prior participation in this trial (no re-enrollment).","ALL","5 Years","10 Years",{"count":55,"type":56},150,"ESTIMATED","INTERVENTIONAL",[59],"NA","Children frequently exhibit pre-MRI anxiety that can cause motion, repeated sequences, prolonged room time, and exposure to sedation. Orientation with Virtual Reality (VR) may reduce anxiety by familiarizing children with the scanner environment and expected sensations. This single-center, three-arm randomized clinical trial evaluates whether (1) Home+Booster VR (an age-appropriate 360° VR module at home \\~24-48 hours before MRI plus a brief on-site refresher immediately before positioning), (2) Pre-Scan VR only (same module viewed on site immediately before positioning), or (3) Usual Care without VR improves MRI image quality and tolerance in children undergoing their first-ever MRI.\n\nEligible participants are children scheduled for clinically indicated, non-emergent MRI with no prior MRI experience. Major exclusions comprise MRI contraindications; contraindications to VR use (e.g., uncontrolled epilepsy or severe motion sickness); uncorrected severe visual\u002Fhearing impairment precluding VR viewing; and inability to provide assent\u002Fconsent. After consent\u002Fassent, participants are randomized 1:1:1 to one of three arms. Anticipated enrollment is \\~150 total (\\~50 per arm; up to 60 per arm if feasible). All arms receive routine safety procedures and child-oriented coaching per institutional practice. The VR module (\\~8-10 minutes) provides a 360° walkthrough of the MRI process (sounds, positioning, keeping still) with child-focused narration. Adherence (timestamps\u002Fduration) is recorded where applicable.\n\nThe primary outcome is motion artifact rated on a predefined ordinal scale by a board-certified radiologist masked to allocation; the proportion achieving diagnostic quality without repeat\u002Fsedation is also reported. Key secondary outcomes include sedation requirement, number of repeated sequences, total scan room time, scan completion without interruption, and change in child anxiety (mYPAS-SF). Additional prespecified measures include comfort\u002Fcalmness Likert scales, Wong-Baker FACES pain, CEMS during scan, parent state anxiety, satisfaction VAS, physiologic vitals (heart rate, blood pressure, SpO₂) at defined peri-scan time points, observed crying and movement durations, and total scan duration. The trial uses parallel assignment with allocation concealment and masked outcome assessment. Analyses follow intention-to-treat with prespecified subgroup exploration by age bands (5-7 vs 8-10). Recruitment is planned for October 6, 2025; primary completion is expected within approximately three months.",[62,63,64,65,66],"Anxiety","Sedation","Child","Virtual Reality","MRI","NOT_YET_RECRUITING","2025-10-01",{"date":70,"type":71},"2025-10-02","ACTUAL",{"date":73,"type":56},"2025-10-06",{"date":75,"type":56},"2026-03-31",{"name":5,"class":6}]