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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00760-49 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| PETRARQUE | UNKNOWN |
| Scalab CNRS 9193 | OTHER |
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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:
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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-report questionnaires, research interviews | Other | self-report questionnaires and research interviews |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Anti-emetic treatments |
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Inclusion Criteria:
Exclusion Criteria:
Contraindication to SNOEZELEN:
State of health not allowing participation in the study (severe fatigue, symptoms refractory to treatment).
Pregnant or breast-feeding women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fanny BEN OUNE | Contact | +33320295918 | promotion@o-lambret.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Recruiting | Lille | 59000 | France |
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Collection of anti-emetic treatments administered during hospitalisation |
| Periprocedural |
| Child-Self Report - PedsQL | Self-questionnaire (ages 8-12 or 13-18) | 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 |
| Number of vomits | Collection of the number of vomits during hospitalisation | Periprocedural |
| Anxiolytic treatments | Collection of anxiolytic treatments received during hospitalization | Periprocedural |
| BARF scale (Baxter Retching Faces) | Evaluation of nausea/vomiting | 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 |
| Children's Depression Inventory - CDI | 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 |
| Child Anxiety Related Emotional Disorders - SCARED | 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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