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

Not Applicable

Not yet recruiting

• Conditions: Snoezelen; Pediatric Cancer; Symptomatologie Anxieuse; Chimiothérapie

• Registration Number: NCT07202507
• Lead Sponsor: Centre Oscar Lambret

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.

Study Timeline

• Study First Submitted: 2025-07-01
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study Start: 2025-09-30
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France