[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608511":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":45,"studyPopulation":38,"armGroups":46,"interventions":53,"overallOfficials":38,"centralContacts":58,"locations":64,"responsibleParty":81,"collaborators":83,"id":89,"slug":38,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":38,"studyType":101,"phases":102,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":66,"whyStopped":38,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Centre Oscar Lambret","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Semi-structured research interview","Interview with a research psychologist to find out how teenage children feel","At the end of the 2nd course of chemotherapy and no more than 2 weeks after the last Snoezelen session, 1 month after inclusion",[14,18,22,25,28,31,34,36],{"measure":15,"description":16,"timeFrame":17},"Generalized Anxiety Disorder - GAD-7","Self-questionnaire","Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months",{"measure":19,"description":20,"timeFrame":21},"Anti-emetic treatments","Collection of anti-emetic treatments administered during hospitalisation","Periprocedural",{"measure":23,"description":24,"timeFrame":17},"Child-Self Report - PedsQL","Self-questionnaire (ages 8-12 or 13-18)",{"measure":26,"description":27,"timeFrame":21},"Number of vomits","Collection of the number of vomits during hospitalisation",{"measure":29,"description":30,"timeFrame":21},"Anxiolytic treatments","Collection of anxiolytic treatments received during hospitalization",{"measure":32,"description":33,"timeFrame":17},"BARF scale (Baxter Retching Faces)","Evaluation of nausea\u002Fvomiting",{"measure":35,"description":16,"timeFrame":17},"Children's Depression Inventory - CDI",{"measure":37,"description":16,"timeFrame":17},"Child Anxiety Related Emotional Disorders - SCARED",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"NA","SINGLE_GROUP","SUPPORTIVE_CARE",{"masking":44,"maskingDescription":38,"whoMasked":38},"NONE","This is a monocentric proof-of-concept study using mixed methods (quantitative questionnaires and qualitative interviews) to explore the potential benefits of Snoezelen as a supportive care intervention in pediatric oncology.\n\nThe goal of this interventional study (minimal risk clinical trial - RIPH2) is to evaluate the effect of the Snoezelen multisensory relaxation approach on anxiety symptoms in children and adolescents aged 8 to 17 years who are hospitalized for chemotherapy in a pediatric oncology unit.\n\nThe primary research question is:\n\n\\- Does the use of Snoezelen reduce anxiety symptoms during hospitalization for chemotherapy in pediatric cancer patients?\n\nSecondary research questions include:\n\n* Does Snoezelen improve quality of life and reduce depressive symptoms?\n* Does Snoezelen reduce nausea and vomiting during chemotherapy? Researchers will compare participants' symptoms before and after a chemotherapy cycle with Snoezelen sessions, and contrast these with data from the previous cycle without Snoezelen.\n\nParticipants will:\n\n* Be enrolled between their first (without Snoezelen) and second (with Snoezelen) chemotherapy cycles\n* Complete self-report questionnaires assessing anxiety (GAD-7, SCARED), depression (CDI), quality of life (PedsQL), and nausea (BARF scale)\n* Receive 45-minute Snoezelen sessions every two days during their second hospitalization for chemotherapy\n* Participate in a semi-structured research interview after the final Snoezelen session The study will also collect data on medications administered (anxiolytics, antiemetics) and the frequency of vomiting episodes during hospitalization.",[47],{"label":48,"type":49,"description":50,"interventionNames":51},"Snoezelen","EXPERIMENTAL","Participants will be enrolled between their first chemotherapy cycle (without Snoezelen) and their second cycle (with Snoezelen). During the study, they will complete self-report questionnaires assessing anxiety, depression, quality of life, and nausea. They will receive 45-minute Snoezelen sessions every two days during their second hospitalization. After the final session, participants will take part in a semi-structured interview. In addition, data will be collected on medications administered (anxiolytics and antiemetics) and on the frequency of vomiting during both hospital stays.",[52],"Other: self-report questionnaires, research interviews",[54],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":38},"self-report questionnaires, research interviews","self-report questionnaires and research interviews",[48],[59],{"name":60,"role":61,"phone":62,"phoneExt":38,"email":63},"Fanny BEN OUNE","CONTACT","+33320295918","promotion@o-lambret.fr",[65],{"facility":5,"status":66,"city":67,"state":38,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Lille","59000","France","FR",{"type":72,"coordinates":73},"Point",[74,75],3.05512,50.63391,{"lat":75,"lon":74},[78],{"name":79,"role":61,"phone":80,"phoneExt":38,"email":63},"Sylvie MERCIER","+33 03 20 29 59 59",{"type":82,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[84,87],{"name":85,"class":86},"PETRARQUE","UNKNOWN",{"name":88,"class":6},"Scalab CNRS 9193","100608511",false,"NCT07202507","Proof-of-Concept Study of the SNOEZELEN Device on Anxiety Symptoms in Patients Hospitalized for Chemotherapy in a Pediatric Oncology Department","SNOOZE","Inclusion Criteria:\n\n* New patient\n* Treated in the Paediatrics\u002FAJA department of the Oscar Lambret Centre for cancer (all types of cancer)\n* Hospitalisation for several days\n* Highly emetogenic chemotherapy treatment: this corresponds to all in-patient treatments carried out in the Paediatrics\u002FAJA department.\n* Age at diagnosis : ≥ 8 years and \\\u003C 18 years.\n* French language\n* Information for the patient and those with parental authority; consent signed by the patient and those with parental authority.\n* Valid social security cover\n\nExclusion Criteria:\n\n* Contraindication to SNOEZELEN:\n\n  * Claustrophobia\n  * Presence of psychiatric, addictive or cognitive disorders that would prevent compliance with the protocol requirements;\n* State of health not allowing participation in the study (severe fatigue, symptoms refractory to treatment).\n* Pregnant or breast-feeding women","ALL","8 Years","18 Years",{"count":99,"type":100},20,"ESTIMATED","INTERVENTIONAL",[40],"The goal of this clinical trial is to evaluate whether the Snoezelen multisensory relaxation approach can reduce anxiety symptoms in children and adolescents aged 8 to 17 years hospitalized for chemotherapy in a pediatric oncology unit.\n\nResearchers will compare patients' symptoms during a chemotherapy cycle with Snoezelen sessions to a previous cycle without Snoezelen, in order to assess changes in psychological and physical well-being.\n\nParticipants will:\n\n* Be enrolled between their first (without Snoezelen) and second (with Snoezelen) chemotherapy cycles\n* Complete self-report questionnaires on anxiety, depression, quality of life, and nausea\n* Receive 45-minute Snoezelen sessions every two days during their second hospitalization\n* Participate in a semi-structured interview after the final session\n* Provide data on medications (anxiolytics, antiemetics) and vomiting frequency during both hospitalizations",[48,105,106,107],"Pediatric Cancer","Symptomatologie Anxieuse","Chimiothérapie",[48,105],"2026-03-16",{"date":111,"type":112},"2026-03-18","ACTUAL",{"date":114,"type":100},"2027-09",{"date":116,"type":100},"2027-10-31",{"name":5,"class":6},1]