[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502381":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":37,"locations":47,"responsibleParty":72,"collaborators":30,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":30,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":30,"enrollmentInfo":83,"targetDuration":30,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":30,"overallStatus":50,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Nice","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","ACTIVE_COMPARATOR","An anticipated analgesia protocol composed of PARACETAMOL 1g +\u002F- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L\u002Fmin flux is administered concomitantly to the reduction procedure.",[13],"Drug: Standard of care",{"label":15,"type":16,"description":17,"interventionNames":18},"Medical device : VR headset","EXPERIMENTAL","Use of a \" virtual reality \" (VR) headset of \" Pico G2 \" type with \" HypnoVR \" software and audio headset \" Taotronics BH22 \" during all the reduction care",[19],"Device: Helmet virtual reality.",{"label":21,"type":16,"description":22,"interventionNames":23},"Medication : Methoxyflurane analgesia","Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)",[24],"Drug: Administration of METHOXYFLURANE",[26,31,35],{"type":27,"name":28,"description":17,"armGroupLabels":29,"otherNames":30},"DEVICE","Helmet virtual reality.",[15],null,{"type":32,"name":33,"description":22,"armGroupLabels":34,"otherNames":30},"DRUG","Administration of METHOXYFLURANE",[21],{"type":32,"name":9,"description":11,"armGroupLabels":36,"otherNames":30},[9],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},"HAMARD Fanny","CONTACT","04 92 03 85 81","hamard.f@chu-nice.fr",{"name":44,"role":40,"phone":45,"phoneExt":30,"email":46},"RAPP Jocelyn","04 92 03 85 35","rapp.j@chu-nice.fr",[48],{"facility":49,"status":50,"city":51,"state":30,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Nice University Hospital","RECRUITING","Nice","06000","France","FR",{"type":56,"coordinates":57},"Point",[58,59],7.26608,43.70313,{"lat":59,"lon":58},[62,65,68,70],{"name":63,"role":40,"phone":64,"phoneExt":30,"email":42},"Fanny Hamard","0492038581",{"name":66,"role":40,"phone":64,"phoneExt":30,"email":67},"laurent Bouchama","bouchama.l@chu-nice.fr",{"name":63,"role":69,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"name":66,"role":71,"phone":30,"phoneExt":30,"email":30},"SUB_INVESTIGATOR",{"type":73,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100502381","phase-4-methoxyflurane-or-virtual-reality-headset-vs-standard-analgesic-management-for-the-reduction-of-anterior-shoulder-dislocation-hypnolux-100502381",false,"NCT05821517","METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)","METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation","Inclusion Criteria:\n\n* Pregnant and\u002For breastfeeding women and women of childbearing age who do not have effective contraception (hormonal, mechanical or surgical).\n* Patients with difficulties in understanding or using the devices studied.\n* Patients with a contraindication to the use of one of the studied devices.\n* Patients with a history of relevant shoulder surgery\n* Presence of other associated trauma,\n* Previous inclusion in the same study\n\nExclusion Criteria:\n\n* Withdrawal of voluntary informed consent from the patient\n* Violation of protocol\n* Presence of a fracture associated with the dislocation (excluding Malgaigne's notches)\n* Posterior, inferior or erecta dislocation\n* Presence of initial vascular and nerve complications\n* Any indication for surgical management","ALL","18 Years",{"count":84,"type":85},150,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","Anterior shoulder dislocation is a pathology frequently encountered in emergency medicine.\n\nThe success in reducing anterior shoulder dislocations depends on muscle relaxation, which is itself conditioned by the patient's pain and apprehension. However, there is no consensus on the optimal technique for reducing anterior shoulder dislocation or the analgesia associated with it.\n\nAnalgesia with METHOXYFLURANE showed a greater reduction in post-traumatic pain compared to standard analgesic treatment and faster action of METHOXYFLURANE. A retrospective study which has compared analgesia with METHOXYFLURANE and analgesic sedation with PROPOFOL found a shoulder reduction success rate of 80% and a reduction in the average length of stay in the emergency department.\n\nFinally, the use of virtual reality in pain management is emerging in our practices by allowing pre- and per-procedure hypno-sedation-analgesia. However, the use of virtual reality headsets has not been studied in the management of anterior shoulder dislocation.\n\nThe use of these two techniques could therefore limit the use of procedural sedation in the context of shoulder dislocation reduction.",[91],"Anterior Shoulder Dislocation","2025-11-27",{"date":94,"type":95},"2025-12-04","ACTUAL",{"date":97,"type":95},"2023-12-30",{"date":99,"type":85},"2027-03",{"name":5,"class":6},1]