Overview
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
Description
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.
The 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.
The primary research question is:
\- Does the use of Snoezelen reduce anxiety symptoms during hospitalization for chemotherapy in pediatric cancer patients?
Secondary research questions include:
- Does Snoezelen improve quality of life and reduce depressive symptoms?
- 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.
Participants will:
- Be enrolled between their first (without Snoezelen) and second (with Snoezelen) chemotherapy cycles
- Complete self-report questionnaires assessing anxiety (GAD-7, SCARED), depression (CDI), quality of life (PedsQL), and nausea (BARF scale)
- Receive 45-minute Snoezelen sessions every two days during their second hospitalization for chemotherapy
- 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.
Eligibility
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
