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Recruiting Not applicable

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

NCT07202507 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2027-09
Last updated
2026-03-18

Condition(s) studied

SnoezelenPediatric CancerSymptomatologie AnxieuseChimiothérapie

Investigational drug(s) / intervention(s)

self-report questionnaires, research interviews

self-report questionnaires, research interviews: self-report questionnaires and research interviews

Study 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

Sex
ALL
Min age
8 Years
Max age
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Centre Oscar Lambret Lille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07202507 on ClinicalTrials.gov ↗ ← All trials in France