[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580193":3},{"organization":4,"armGroups":7,"interventions":83,"overallOfficials":93,"centralContacts":98,"locations":108,"responsibleParty":181,"collaborators":126,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":185,"sex":191,"minAge":192,"maxAge":126,"enrollmentInfo":193,"targetDuration":126,"studyType":196,"phases":197,"briefSummary":199,"conditions":200,"keywords":126,"overallStatus":111,"whyStopped":126,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"Centre Hospitalier Régional d'Orléans","OTHER",[8,14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68,71,74,77,80],{"label":9,"type":10,"description":11,"interventionNames":12},"DCBA (specific order of procedures with type of injection site and\u002For use virtual reality headset)","EXPERIMENTAL","A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset",[13],"Procedure: Dorsogluteal intramuscular injection",{"label":15,"type":10,"description":11,"interventionNames":16},"CDBA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"DBCA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"BDCA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"CBDA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"BCDA (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":30,"type":10,"description":11,"interventionNames":31},"DCAB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":33,"type":10,"description":11,"interventionNames":34},"CDAB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":36,"type":10,"description":11,"interventionNames":37},"DACB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":39,"type":10,"description":11,"interventionNames":40},"ADCB (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":42,"type":10,"description":11,"interventionNames":43},"CADB (specific 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headset)",[13],{"label":60,"type":10,"description":11,"interventionNames":61},"BADC (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":63,"type":10,"description":11,"interventionNames":64},"ABDC (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":66,"type":10,"description":11,"interventionNames":67},"CBAD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":69,"type":10,"description":11,"interventionNames":70},"BCAD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":72,"type":10,"description":11,"interventionNames":73},"CABD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":75,"type":10,"description":11,"interventionNames":76},"ACBD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":78,"type":10,"description":11,"interventionNames":79},"BACD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],{"label":81,"type":10,"description":11,"interventionNames":82},"ABCD (specific order of procedures with type of injection site and\u002For use virtual reality headset)",[13],[84],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"PROCEDURE","Dorsogluteal intramuscular injection","The injection is carried out on the dorsogluteal intramuscular site, without virtual reality headset\n\nThe injection is carried out on the ventrogluteal intramuscular site, without virtual reality headset\n\nThe injection is carried out on the dorsogluteal intramuscular site, with virtual reality headset\n\nThe injection is carried out on the ventrogluteal intramuscular site, with virtual reality headset",[81,63,75,45,57,39,78,60,69,27,51,21,72,42,66,24,33,15,54,36,48,18,30,9],[90,91,92],"Ventrogluteal intramuscular injection","Dorsogluteal intramuscular injection with virtual reality headset","Ventro-gluteal intramuscular injection with virtual reality headset",[94],{"name":95,"affiliation":96,"role":97},"Daniela PIRES ROTEIA","CHU Orléans","PRINCIPAL_INVESTIGATOR",[99,104],{"name":95,"role":100,"phone":101,"phoneExt":102,"email":103},"CONTACT","02 38 65 13 38","+33","daniela.pires-roteia@chu-orleans.fr",{"name":105,"role":100,"phone":106,"phoneExt":102,"email":107},"Fanny LOUAT","02 38 74 42 95","fanny.louat@chu-orleans.fr",[109,127,140,154,168],{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"Center Hospitalier Universitaire d'Orléans","RECRUITING","Orléans","Loiret","45067","France","FR",{"type":118,"coordinates":119},"Point",[120,121],1.90407,47.90248,{"lat":121,"lon":120},[124],{"name":95,"role":100,"phone":125,"phoneExt":126,"email":103},"0238651338",null,{"facility":128,"status":111,"city":129,"state":126,"zip":130,"country":115,"countryCode":116,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"CHD Vendée","La Roche-sur-Yon","85925",{"type":118,"coordinates":132},[133,134],-1.42757,46.66974,{"lat":134,"lon":133},[137],{"name":138,"role":100,"phone":126,"phoneExt":102,"email":139},"Dominique MERRIEN, Dr","dominique.merrien@ght85.fr",{"facility":141,"status":111,"city":142,"state":126,"zip":143,"country":115,"countryCode":116,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"CH Chartres","Le Coudray","28630",{"type":118,"coordinates":145},[146,147],1.50057,48.42115,{"lat":147,"lon":146},[150],{"name":151,"role":100,"phone":152,"phoneExt":102,"email":153},"Iuliana DARASTEANU, Dr","0237303030","idarasteanu@ch-chartres.fr",{"facility":155,"status":111,"city":156,"state":126,"zip":157,"country":115,"countryCode":116,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"CHU Nantes","Nantes","44093",{"type":118,"coordinates":159},[160,161],-1.55336,47.21725,{"lat":161,"lon":160},[164],{"name":165,"role":100,"phone":166,"phoneExt":102,"email":167},"Clotilde ALLAVENA, Dr","0240083109","clotilde.allavena@chu-nantes.fr",{"facility":169,"status":111,"city":170,"state":126,"zip":171,"country":115,"countryCode":116,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"CHU Poitiers","Poitiers","90577",{"type":118,"coordinates":173},[174,175],0.34348,46.58261,{"lat":175,"lon":174},[178],{"name":179,"role":100,"phone":126,"phoneExt":126,"email":180},"Gwenaël LE MOAL, Dr","gwenael.lemoal@chu-poitiers.fr",{"type":182,"investigatorFullName":126,"investigatorTitle":126,"investigatorAffiliation":126,"oldNameTitle":126,"oldOrganization":126},"SPONSOR","100580193","impact-of-pain-from-injectables-antiretroviral-treatments-in-hiv-1-patients-based-on-the-injection-site-ventrogluteal-or-dorsogluteal-and-the-use-or-non-use-of-virtual-reality-headset-100580193",false,"NCT06834113","Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset","Impact of Two Types of Interventions (Ventrogluteal Versus Dorsogluteal Injection Site; Virtual Reality Headset: Presence or Absence) on Pain After Injections of Vocabria® (Cabotegravir) and Rekambys® (Rilpivirine) in Patients Infected With Human Immunodeficiency Virus -1","VIHINJECT","Inclusion Criteria:\n\n* Patient aged at least 18 years;\n* Patient infected with HIV-1;\n* Patient virologically controlled (VL \\\u003C 50 copies\u002Fml);\n* Patient scheduled to receive treatment with cabotegravir and rilpivirine (naïve patients) or currently on injectable cabotegravir and rilpivirine, prescribed by their referring physician.\n\nExclusion Criteria:\n\n* Patient(s) on another injectable antiretroviral treatment;\n* Patient participating in another clinical trial with medication;\n* Patient(s) with epilepsy;\n* Patient on antidepressant treatment;\n* Patient(s) with psychiatric or behavioral disorders;\n* Patient(s) with a history of dizziness and motion sickness that prevents the use of virtual reality headset;\n* Patient(s) with visual and hearing impairments that prevent the use of virtual reality headset;\n* Patient(s) deprived of liberty, under guardianship or under curatorship;\n* Patient(s) not affiliated with a social security scheme;\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":194,"type":195},120,"ESTIMATED","INTERVENTIONAL",[198],"NA","This is a multicenter, randomized, open-label study with a cross-over design. The objective of this project is to compare the intensity of pain induced by injectable antiretroviral (ARV) treatment (Cabotegravir® and Rilpivirine®) in patients infected with HIV-1, depending on the injection site and whether or not they are wearing a virtual reality headset. The reference group being the dorsogluteal injection without headset.\n\nParticipants who meet the study criteria will be randomized into 1 of 24 sequences. A sequence is composed by 4 injections procedures: dorsogluteal intramuscular injection (A), ventrogluteal intramuscular injection (B), dorsogluteal intramuscular injection with virtual reality headset (C), ventrogluteal intramuscular injection with virtual reality headset (D).\n\nEach patient will be their own witness and will experience the 4 intramuscular injection procedures of injectable antiretroviral.\n\nThe study population are patients carrying HIV-1 and being monitored for this pathology, eligible (naïve patients) or already under Cabotegravir® (CAB) and Rilpivirine® (RPV) injectable treatment.",[201,202],"HIV I Infection","Injection Pain","2025-12-22",{"date":205,"type":206},"2025-12-30","ACTUAL",{"date":208,"type":206},"2025-01-24",{"date":210,"type":195},"2026-09-24",{"name":5,"class":6},5]