NCT07202507

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Sep 2027

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2027

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

July 1, 2025

Last Update Submit

March 16, 2026

Conditions

SnoezelenPediatric CancerSymptomatologie AnxieuseChimiothérapie

Keywords

SnoezelenPediatric Cancer

Outcome Measures

Primary Outcomes (1)

  • Semi-structured research interview

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

    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 (8)

  • Generalized Anxiety Disorder - GAD-7

    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

  • Anti-emetic treatments

    Periprocedural

  • Child-Self Report - PedsQL

    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

  • Number of vomits

    Periprocedural

  • Anxiolytic treatments

    Periprocedural

  • +3 more secondary outcomes

Study Arms (1)

Snoezelen

EXPERIMENTAL

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.

Other: self-report questionnaires, research interviews

Interventions

self-report questionnaires, research interviewsOTHER

self-report questionnaires and research interviews

Snoezelen

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Fanny BEN OUNE

CONTACT

+33320295918promotion@o-lambret.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2025

First Posted

October 1, 2025

Study Start (Estimated)

September 1, 2027

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)