[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554862":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":32,"centralContacts":36,"locations":23,"responsibleParty":41,"collaborators":23,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":23,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":23,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":23,"overallStatus":64,"whyStopped":23,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":23},{"fullName":5,"class":6},"Children's Hospital Los Angeles","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Virtual Reality","EXPERIMENTAL","Within the active virtual reality group virtual environment, participants will play the game Bearblast using Oculus Go Headset for patients 8-21 years old. In BearBlast, participants travel on a pre-set path through an interactive environment.",[13],"Device: Active Virtual Reality",{"label":15,"type":10,"description":16,"interventionNames":17},"Passive Virtual Reality","Within the passive virtual reality group virtual environment and age appropriate movie.",[18],"Device: Passive Virtual Reality",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard of Care","NO_INTERVENTION","Participants will receive standard of care distraction methods.",null,[25,29],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":23},"DEVICE","Active virtual reality group will play a game through a virtual environment.",[9],{"type":26,"name":15,"description":30,"armGroupLabels":31,"otherNames":23},"Passive virtual reality group will watch a movie through a virtual environment.",[15],[33],{"name":34,"affiliation":5,"role":35},"Matan Paret, MD","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":23,"email":40},"CONTACT","3233764793","mparet@chla.usc.edu",{"type":35,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Matan Paret","Principal Investigator","100554862","pain-elimination-and-anxiety-control-through-experiential-virtual-reality-100554862",false,"NCT06504602","Pain Elimination and Anxiety Control Through Experiential Virtual Reality","Inclusion Criteria:\n\n* Children and adolescents 8-21 years old undergoing IV placement .\n\n  * Ability to understand study procedures and to comply with them for the entire length of the study.\n  * Participants and caregiver speaking English or Spanish.\n\nExclusion Criteria:\n\n* Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).\n\n  * Participants receiving narcotics, opioids, or anxiolytics 8 hours prior (Tylenol and ibuprofen do not count).\n  * Participants with pain so significant that consent\u002Fassent is not possible (decision based on treating clinician evaluation).\n  * Critically ill Participants (ESI 1).",true,"ALL","8 Years","21 Years",{"count":55,"type":56},96,"ESTIMATED","INTERVENTIONAL",[59],"NA","The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\n* Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?\n* Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?\n\nIf there is a comparison group: Researchers will compare active group to passive group and standard of care.\n\nParticipants will randomized into active virtual reality, passive virtual reality or standard of care arms.",[62,63],"Procedural Pain","Procedural Anxiety","NOT_YET_RECRUITING","2024-07-16",{"date":67,"type":68},"2024-07-18","ACTUAL",{"date":70,"type":56},"2024-09-01",{"date":72,"type":56},"2025-03-15",{"name":5,"class":6}]