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

Sponsor
Centre Oscar Lambret
Study ID
NCT07202507
Status
Recruiting

Conditions

  • Chimiothérapie
  • Pediatric Cancer
  • Snoezelen
  • Symptomatologie Anxieuse

Eligibility Criteria

Sex
ALL
Age
8 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • self-report questionnaires, research interviews — OTHER
    self-report questionnaires and research interviews

Study Details

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

Key Dates

First listed
Oct 1, 2025
Start date
Sep 30, 2027
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.

Primary Outcome Measure

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 ]

Central Contacts

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