Chimiothérapie, Pediatric Cancer, Snoezelen, Symptomatologie Anxieuse
Conditions
Keywords
Snoezelen, Pediatric Cancer
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
Detailed 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.
Interventions
OTHERself-report questionnaires, research interviews
self-report questionnaires and research interviews
Sponsors
Centre Oscar Lambret
PETRARQUE
Scalab CNRS 9193
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Semi-structured research interview | At the end of the 2nd course of chemotherapy and no more than 2 weeks after the last Snoezelen session, 1 month after inclusion | Interview with a research psychologist to find out how teenage children feel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder - GAD-7 | 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 | Self-questionnaire |
| Anti-emetic treatments | Periprocedural | Collection of anti-emetic treatments administered during hospitalisation |
| Child-Self Report - PedsQL | 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 | Self-questionnaire (ages 8-12 or 13-18) |
| Number of vomits | Periprocedural | Collection of the number of vomits during hospitalisation |
| Anxiolytic treatments | Periprocedural | Collection of anxiolytic treatments received during hospitalization |
| BARF scale (Baxter Retching Faces) | 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 | Evaluation of nausea/vomiting |
| Children's Depression Inventory - CDI | 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 | Self-questionnaire |
| Child Anxiety Related Emotional Disorders - SCARED | 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 | Self-questionnaire |
Countries
France
Contacts
CONTACTFanny BEN OUNE
Outcome results
None listed