[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434220":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":36,"responsibleParty":50,"collaborators":24,"id":52,"slug":24,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":24,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":24,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Centre Antoine Lacassagne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A_ first with RV then without","EXPERIMENTAL","Use of the virtual reality headset from the first week of proton therapy",[13],"Procedure: Virtual reality",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B- first without RV than with","Use of the virtual reality headset from the second week of proton therapy",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Virtual reality","Before proton therapy, virtual reality sessions will be performed.",[9,15],null,[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Amandine STARZYK","CONTACT","04-92-03-10-75","+33","amandine.starzyk@nice.unicancer.fr",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Pierre-Yves BONDIAU, M.D, PhD","04-92-03-12-73","pierre-yves.bondiau@nice.unicancer.fr",[37],{"facility":5,"status":38,"city":39,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Nice","France","FR",{"type":43,"coordinates":44},"Point",[45,46],7.26608,43.70313,{"lat":46,"lon":45},[49],{"name":27,"role":28,"phone":24,"phoneExt":30,"email":31},{"type":51,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100434220",false,"NCT04934293","Virtual Reality for Children in Radiotherapy (REVER)","REVER","Inclusion Criteria:\n\n* Patient treated at the Antoine LACASSAGNE Center for treatment by proton therapy\n* Age ≥ 7 years old and ≤ 18 years old\n* Patient, and parents for minor children, having read the information notice and signed the informed consent,\n* Patient with social security coverage.\n\nExclusion Criteria:\n\n* Age \\\u003C 7 years old and \\> 18 years old,\n* Patient under general anesthesia,\n* Patient suffering from wounds or infections in the head, deemed incompatible with the use of the helmet by the investigator,\n* Patient suffering from respiratory problems,\n* Patient suffering from a high level of claustrophobia,\n* Patient followed for a psychiatric pathology,\n* Patient suffering from unbalanced epilepsy,\n* Patient suffering from visual (binocular vision) and \u002F or hearing disorders preventing the use of virtual reality,\n* Patient whose head circumference is insufficient for the use of the helmet, deemed incompatible with the use of the helmet by the investigator,\n* Patient treated by radio chemotherapy.","ALL","7 Years","18 Years",{"count":62,"type":63},47,"ESTIMATED","INTERVENTIONAL",[66],"NA","For a young patient, the conditions of proton therapy treatment can be stressful. Adjusting the environment can be a source of avoiding this physical and psychological discomfort impacting the quality of treatment.\n\nA fixed, long, uncomfortable position is the main cause of stress, already present due to the cancerous therapeutic course. It extends the positioning time. For the patient and the optimization of his treatment, solutions must be sought.\n\nRelaxation in virtual reality is efficient, simple and non-medicinal and could reduce stress in children and allow irradiation in very good conditions.\n\nWe will assess the effectiveness of the virtual reality session using objective (placement time, helmet tolerance) and subjective (perceived anxiety via a dedicated questionnaire) criteria. This is the first pediatric virtual reality study, supported by the French Group of Pediatric Radiotherapists, to reduce anxiety in radiotherapy.\n\nMultiple benefits from this pilot study are expected, such as improved reception conditions, treatment parameters and better acceptance of proton therapy sessions.",[69,70,71],"Virtual Reality","Proton Therapy","Pediatric Cancer","2026-05-27",{"date":74,"type":75},"2026-05-29","ACTUAL",{"date":77,"type":75},"2021-08-02",{"date":79,"type":63},"2027-02",{"name":5,"class":6},1]