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NCT Number: NCT07202507

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

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

Recruiting

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-report questionnaires, research interviews

Other

self-report questionnaires and research interviews

Primary outcomes

  1. Semi-structured research interview

    Time frame: 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 outcomes

  1. Generalized Anxiety Disorder - GAD-7

    Time frame: 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

  2. Anti-emetic treatments

    Time frame: Periprocedural

    Collection of anti-emetic treatments administered during hospitalisation

  3. Child-Self Report - PedsQL

    Time frame: 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)

  4. Number of vomits

    Time frame: Periprocedural

    Collection of the number of vomits during hospitalisation

  5. Anxiolytic treatments

    Time frame: Periprocedural

    Collection of anxiolytic treatments received during hospitalization

  6. BARF scale (Baxter Retching Faces)

    Time frame: 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

  7. Children's Depression Inventory - CDI

    Time frame: 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

  8. Child Anxiety Related Emotional Disorders - SCARED

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fanny BEN OUNE

CONTACT

[email protected]

+33320295918

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • PETRARQUE
  • Scalab CNRS 9193

Registry information

Acronym: SNOOZE

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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