RecruitingNot ApplicableNCT07202507

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

Enrollment

20 participants

Start Date

Sep 1, 2027

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 18 Years

Inclusion Criteria8

  • 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 Criteria5

  • 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

Interventions

OTHERself-report questionnaires, research interviews

self-report questionnaires and research interviews


Locations(1)

Centre Oscar Lambret

Lille, France

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NCT07202507


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