[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"children-and-adolescents\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:children-and-adolescents":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Virtual Reality","Children and Adolescents","Acute Leukemia","Anxiety and Fear",[33,34,35],"acute leukemia","virtual reality mask","children and adolescents from 6 to 16","RECRUITING","2025-12-02",{"date":39,"type":40},"2025-12-04","ACTUAL",{"date":42,"type":40},"2024-11-15",{"date":44,"type":22},"2027-10-01",{"name":46,"class":47},"University Hospital, Clermont-Ferrand","OTHER",4]