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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorCentre Oscar Lambret

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • self-report questionnaires, research interviews

    Other intervention

    self-report questionnaires and research interviews

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: SnoezelenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Semi-structured research interview

Interview with a research psychologist to find out how teenage children feel

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

Secondary outcomes

1

Generalized Anxiety Disorder - GAD-7

Self-questionnaire

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
2

Anti-emetic treatments

Collection of anti-emetic treatments administered during hospitalisation

Time frame
Periprocedural
3

Child-Self Report - PedsQL

Self-questionnaire (ages 8-12 or 13-18)

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
4

Number of vomits

Collection of the number of vomits during hospitalisation

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Oscar Lambret

Lead sponsor

PETRARQUE

Collaborator

Scalab CNRS 9193

Collaborator