NCT07202507

Proof-of-Concept Study of the SNOEZELEN Device on Anxiety Symptoms in Patients Hospitalized for Chemotherapy in a Pediatric Oncology Department

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Snoezelen
• Pediatric Cancer
• Symptomatologie Anxieuse
• Chimiothérapie

Interventions

Type	Name	Description
OTHER	self-report questionnaires, research interviews	self-report questionnaires and research interviews

Timeline

• Start date: 2027-09-01
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2025-10-01
• Last updated: 2026-03-18

Locations

1 site across 1 country: France