[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575548":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":35,"responsibleParty":59,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":12,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":12,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Louisiana State University Health Sciences Center in New Orleans","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Controls","NO_INTERVENTION","Control patients will continue to receive the standard of care for their vaso-occlusive pain (IV fluid hydration, scheduled IV NSAID, and opiate medication) and have repeat pain assessments at 1 hour and 4 hours from their baseline assessment. This same timeline will occur on days 2 and 3 of admission",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Cases","EXPERIMENTAL","In addition to receiving the standard of care for their vaso-occlusive pain, the case patients will have the opportunity to participate in the immersive VR experience after completing their initial pain assessment simulator sickness survey. Following the intervention, their pain levels will be reassessed at the 1-hour and 4-hour mark from their baseline assessment. Additionally, they will be asked to fill out an additional simulator sickness survey upon completion of the VR experience. This same timeline will occur on days 2 and 3 of admission. Prior to discharge or discontinuation from the study, the case patients will be asked to fill out the post-study questionnaire.",[18],"Device: KindVR Aqua Program",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","KindVR Aqua Program","For this study, patients will be introduced to a virtual reality software program called Aqua, created by the company KindVR. This software program was designed specifically for use in pediatric patients. The software has been programmed into the Pico Neo 3 headset and provides an immersive 3D experience during which the patients explore a virtual underwater world inside a submarine with a goal of providing more color to treasure and different sea animals that they will engage with along their journey. The VR experience itself lasts approximately 15 minutes",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Molly E Sonenklar, MD","CONTACT","504-896-9740","msonen@lsuhsc.edu",{"name":32,"role":28,"phone":33,"phoneExt":12,"email":34},"Casey M Treuting, MD","504-273-3476","ctreu1@lsuhsc.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Children's Hospital of New Orleans","RECRUITING","New Orleans","Louisiana","70118","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-90.07507,29.95465,{"lat":48,"lon":47},[51,52,53,54,56,58],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":12,"email":34},{"name":27,"role":28,"phone":12,"phoneExt":12,"email":12},{"name":55,"role":28,"phone":12,"phoneExt":12,"email":12},"Dana M Leblanc, MD",{"name":57,"role":28,"phone":12,"phoneExt":12,"email":12},"Cori A Morrison, MD",{"name":32,"role":28,"phone":12,"phoneExt":12,"email":12},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Molly Sonenklar","Assistant Professor in Pediatrics",[64],{"name":65,"class":66},"KindVR","UNKNOWN","100575548","virtual-reality-as-adjunct-therapy-for-vaso-occlusive-pain-100575548",false,"NCT06773715","Virtual Reality As Adjunct Therapy for Vaso-Occlusive Pain","Changing the View of Pain: Using Virtual Reality As Adjunctive Therapy for Sickle Cell Pain in Pediatric Patients","Inclusion Criteria:\n\n1. Patient ≥ 8 up to 21 years of age\n2. Presenting to CHNOLA ER or outside facility with chief complaint of vaso-occlusive pain crisis, requiring inpatient admission for further pain management\n3. No known cognitive or neurological deficits\n4. Parental\u002Fguardian permission (informed consent) and if appropriate, child assent.\n\nExclusion Criteria:\n\n1. Patients aged 7-years-old and younger.\n2. Patents upon admission found to have sequela of their sickle cell disease that would require medical therapy greater than the standard of care for a vaso-occlusive pain event. This includes acute chest syndrome, splenic sequestration, post-operative pain, and\u002For cerebrovascular accident\n3. Patients who are developmentally or cognitively incapable of using VR equipment and answering questions appropriately\n4. Failure to obtain or refusal to provide parental\u002Fguardian permission (informed consent) and if appropriate child assent\n5. Patient has previously participated in the study\n6. Study team is unable to initiate study interventions within the first 24 hours of a patient's admission","ALL","8 Years","21 Years",{"count":78,"type":79},36,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this randomized control clinical trial is to learn if virtual reality can be used to treat sickle cell pain in children. The main questions it aims to answer are:\n\nDoes virtual reality reduce pain severity during a child's hospital stay for a vaso-occlusive pain crisis?\n\nDoes virtual reality decrease the daily use of opiates?\n\nResearchers will compare standard therapy to the use of standard therapy plus a daily virtual reality experience to see if virtual reality works to treat sickle cell pain.\n\nAll patients will:\n\n\\- Be asked to fill out a pain assessment survey three times daily for up to 3 days\n\nIf randomized to intervention arm, patients will:\n\n* Participate in an immersive virtual reality experience once daily for up to 3 days\n* Fill out a survey twice daily to monitor for side effects from virtual reality experience\n* Fill out a satisfaction survey once during the study period",[85,86],"Sickle Cell Disease","Vaso-occlusive Pain Episodes",[88,89,90,91],"virtual reality","adjunctive therapy","opiate consumption","pain reduction","2025-01-13",{"date":94,"type":95},"2025-01-14","ACTUAL",{"date":97,"type":95},"2024-09-12",{"date":99,"type":79},"2025-12-19",{"name":5,"class":6},1]