NCT07202507 Proof-of-Concept Study of the SNOEZELEN Device on Anxiety Symptoms in Patients Hospitalized for Chemotherapy in a Pediatric Oncology Department
| NCT ID | NCT07202507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Oscar Lambret |
| Condition | Snoezelen |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2027-09 |
| Primary Completion | 2027-10-31 |
Trial Parameters
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Brief Summary
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. Researchers 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. Participants will: * Be enrolled between their first (without Snoezelen) and second (with Snoezelen) chemotherapy cycles * Complete self-report questionnaires on anxiety, depression, quality of life, and nausea * Receive 45-minute Snoezelen sessions every two days during their second hospitalization * Participate in a semi-structured interview after the final session * Provide data on medications (anxiolytics, antiemetics) and vomiting frequency during both hospitalizations
Eligibility Criteria
Inclusion Criteria: * New patient * Treated in the Paediatrics/AJA department of the Oscar Lambret Centre for cancer (all types of cancer) * Hospitalisation for several days * Highly emetogenic chemotherapy treatment: this corresponds to all in-patient treatments carried out in the Paediatrics/AJA department. * Age at diagnosis : ≥ 8 years and \< 18 years. * French language * Information for the patient and those with parental authority; consent signed by the patient and those with parental authority. * Valid social security cover Exclusion Criteria: * Contraindication to SNOEZELEN: * Claustrophobia * Presence of psychiatric, addictive or cognitive disorders that would prevent compliance with the protocol requirements; * State of health not allowing participation in the study (severe fatigue, symptoms refractory to treatment). * Pregnant or breast-feeding women