Proof-of-Concept Study of the SNOEZELEN Device on Anxiety Symptoms in Patients Hospitalized for Chemotherapy in a Pediatric Oncology Department
NCT ID: NCT07202507
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-09-30
2027-10-31
Brief Summary
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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
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Snoezelen
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.
self-report questionnaires, research interviews
self-report questionnaires and research interviews
Interventions
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self-report questionnaires, research interviews
self-report questionnaires and research interviews
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
18 Years
ALL
No
Sponsors
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PETRARQUE
UNKNOWN
Scalab CNRS 9193
OTHER
Centre Oscar Lambret
OTHER
Responsible Party
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Locations
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Centre Oscar Lambret
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A00760-49
Identifier Type: OTHER
Identifier Source: secondary_id
SNOOZE-2501
Identifier Type: -
Identifier Source: org_study_id
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