[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569671":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":105,"collaborators":30,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":30,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":130,"overallStatus":50,"whyStopped":30,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard method","ACTIVE_COMPARATOR","In this standard method, before the treatment, the procedure of inserting the needle into the implantable port is explained to the child. The patient is comfortably installed and the treatment start using the standard method which consist on distracting the patient by singing, story telling, talking etc..\n\nUse of local anesthesic cream and +\u002F- anxiolytic gas",[13],"Other: Standard method",{"label":15,"type":10,"description":16,"interventionNames":17},"Interactive virtual reality","Before the treatment, the caregiver explains the procedure of inserting the needle into the implantable port. A general explanation is given on the VR device (how the headphones and headsets are placed), presentation of the virtual worlds to choose from, description of the course of the session (virtual travel is guided by a voice). For the interactive virtual reality, the mode of operation will be explained as the actions are validated using the eyes.\n\nThe patient is then installed comfortably. The caregiver helps the child to put on the headphones and headset correctly. Before starting the care procedure, the caregiver will wait about 5 minutes after the start of the viewing to make sure the child is completely immersed in the virtual reality. The software is turned off about 3 minutes after the end of the care procedure.\n\nUse of local anesthesic cream.",[18],"Device: Interactive virtual reality",{"label":20,"type":10,"description":21,"interventionNames":22},"Hypnotic virtual reality","Before the treatment, the caregiver explains the procedure of inserting the needle into the implantable port to the child. A general explanation is given on the VR device (how the headphones and headsets are placed), presentation of the virtual worlds to choose from, description of the course of the session (virtual travel is guided by a voice). The patient is then installed comfortably. The caregiver helps the child to put on the headphones and headset correctly. Before starting the care procedure, the caregiver will wait about 5 minutes after the start of the viewing to make sure the child is completely immersed in the virtual reality. The software is turned off about 3 minutes after the end of the care procedure.\n\nUse of local anesthesic cream.",[23],"Device: Hypnotic Virtual reality",[25,31,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Hypnotic Virtual reality","Hypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy®",[20],null,{"type":26,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Interactive virtual reality mask Deepsen® with age-appropriate software Birdy®",[15],{"type":6,"name":9,"description":35,"armGroupLabels":36,"otherNames":30},"Use of local anesthesic cream + Nurse and\u002For parents distraction +\u002F- anxioloytic gas",[9],[38],{"name":39,"affiliation":5,"role":40},"Alexandra USCLADE","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":30,"email":46},"Lise LACLAUTRE","CONTACT","+33473754963","promo_interne_drci@chu-clermontferrand.fr",[48,66,79,92],{"facility":49,"status":50,"city":51,"state":30,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"CHU de Bordeaux","RECRUITING","Bordeaux","33000","France","FR",{"type":56,"coordinates":57},"Point",[58,59],-0.58046,44.84124,{"lat":59,"lon":58},[62,64],{"name":63,"role":44,"phone":45,"phoneExt":30,"email":46},"Lise Laclautre",{"name":65,"role":40,"phone":30,"phoneExt":30,"email":30},"Clémentine Zannettacci",{"facility":67,"status":50,"city":68,"state":30,"zip":69,"country":53,"countryCode":54,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"CHU de Clermont-Ferrand","Clermont-Ferrand","63000",{"type":56,"coordinates":71},[72,73],3.08682,45.77969,{"lat":73,"lon":72},[76,77],{"name":63,"role":44,"phone":45,"phoneExt":30,"email":46},{"name":78,"role":40,"phone":30,"phoneExt":30,"email":30},"Emmanuelle Labraise",{"facility":80,"status":50,"city":81,"state":30,"zip":82,"country":53,"countryCode":54,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Assistance Publique - Hôpitaux de Marseille","Marseille","13005",{"type":56,"coordinates":84},[85,86],5.38107,43.29695,{"lat":86,"lon":85},[89,90],{"name":63,"role":44,"phone":45,"phoneExt":30,"email":46},{"name":91,"role":40,"phone":30,"phoneExt":30,"email":30},"Julie Soler",{"facility":93,"status":50,"city":94,"state":30,"zip":95,"country":53,"countryCode":54,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"CHU de Toulouse","Toulouse","31059",{"type":56,"coordinates":97},[98,99],1.44367,43.60426,{"lat":99,"lon":98},[102,103],{"name":63,"role":44,"phone":45,"phoneExt":30,"email":46},{"name":104,"role":40,"phone":30,"phoneExt":30,"email":30},"Silvi Bador",{"type":106,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100569671","evaluation-of-the-efficacy-of-a-virtual-reality-when-placing-a-needle-on-an-implantable-venous-access-device-in-children-with-leukemia-100569671",false,"NCT06697275","Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia","Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia: Randomized Multicenter Trial","LEAVE","Inclusion Criteria:\n\n* Children from 6 to 16 years old suffering from leukemia requiring needle insertion into an implantable port and having a life expectancy greater than or equal to 3 months\n* Subjects and their parents who have been informed of the study and having expressed their informed consent\n* Children without contraindications to the use of MEOPA® :\n* Patient requiring 100% oxygen ventilation\n* Intracranial hypertension\n* Any alteration in the state of consciousness preventing the patient\\'s cooperation\n* Children without contraindication to the use of the virtual reality mask:\n* Epilepsy\n* Psychiatric illness\n* Children and parents able to use the self-assessment scales proposed in the study\n* Enrolment in the Social Security system\n\nExclusion Criteria:\n\nChildren from 6 to 16:\n\n* Having a modification of pain\\'s integration (spina bifida for example)\n* Requiring contact isolation (conjunctivitis, contagious skin condition, etc.)\n* With a history of seizures","ALL","6 Years","16 Years",{"count":119,"type":120},120,"ESTIMATED","INTERVENTIONAL",[123],"NA","Main objective:\n\nEvaluate the effectiveness of the repeated use of interactive or hypnotic virtual reality compared to standard treatment, on pain, during each needle placement on PAC for 3 months on children or adolescents (6 to 16 years old) with acute leukemia\n\nHypothesis:\n\nRepeated use over 3 months of hypnotic or interactive virtual reality provides more benefits in terms of :\n\n* pain management\n* anxiety of the child and his parents\n* satisfaction of the child's care, of his parents and of the caregivers compared to the standard method when inserting a needle into an implantable port in the pediatric oncology department or day hospital.",[126,127,128,129],"Virtual Reality","Children and Adolescents","Acute Leukemia","Anxiety and Fear",[131,132,133],"acute leukemia","virtual reality mask","children and adolescents from 6 to 16","2025-12-02",{"date":136,"type":137},"2025-12-04","ACTUAL",{"date":139,"type":137},"2024-11-15",{"date":141,"type":120},"2027-10-01",{"name":5,"class":6},4]