SnoezelenSNOOZENCT07202507
Proof-of-Concept Study of the SNOEZELEN Device on Anxiety Symptoms in Patients Hospitalized for Chemotherapy in a Pediatric Oncology Department
A study testing self-report questionnaires, research interviews in people with Snoezelen and Pediatric Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Snoezelen, Pediatric Cancer, Symptomatologie Anxieuse
- What is being tested?
- self-report questionnaires, research interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2027to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Oscar Lambret
Lille, 59000
Sylvie MERCIER, +33 03 20 29 59 59, promotion@o-lambret.fr
About this study
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.
Read more
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
Read the detailed description
This is a monocentric proof-of-concept study using mixed methods (quantitative questionnaires and qualitative interviews) to explore the potential benefits of Snoezelen as a supportive care intervention in pediatric oncology.
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
- Snoezelen, Pediatric Cancer, Symptomatologie Anxieuse, Chimiothérapie
- Being tested
- self-report questionnaires, research interviews
- Keywords
- Snoezelen, Pediatric Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-report questionnaires, research interviewsOther
self-report questionnaires and research interviews
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: self-report questionnaires, research interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured research interview
Interview with a research psychologist to find out how teenage children feel
Measured: 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
Self-questionnaire
Measured: 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
Collection of anti-emetic treatments administered during hospitalisation
Measured: Periprocedural
Child-Self Report - PedsQL
Self-questionnaire (ages 8-12 or 13-18)
Measured: 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
Collection of the number of vomits during hospitalisation
Measured: Periprocedural
Anxiolytic treatments
Collection of anxiolytic treatments received during hospitalization
Measured: Periprocedural
BARF scale (Baxter Retching Faces)
Evaluation of nausea/vomiting
Measured: 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
Children's Depression Inventory - CDI
Self-questionnaire
Measured: 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
Child Anxiety Related Emotional Disorders - SCARED
Self-questionnaire
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startSep 2027 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoezelenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- PETRARQUE, Scalab CNRS 9193
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202507
- Sponsor's protocol ID
- SNOOZE-2501
- Other IDs
- 2025-A00760-49
- Acronym
- SNOOZE
- Status last verified
- Mar 2026
- First submitted
- 1 Jul 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept Study of the SNOEZELEN Device on Anxiety Symptoms in Patients Hospitalized for Chemotherapy in a Pediatric Oncology Department
- ClinicalTrials.gov ID
- NCT07202507
- Acronym / sponsor ID
- SNOOZE / SNOOZE-2501
- Conditions
- Snoezelen, Pediatric Cancer, Symptomatologie Anxieuse, Chimiothérapie
- Keywords
- Snoezelen, Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- PETRARQUE, Scalab CNRS 9193
- Study start
- Sep 2027 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a monocentric proof-of-concept study using mixed methods (quantitative questionnaires and qualitative interviews) to explore the potential benefits of Snoezelen as a supportive care intervention in pediatric oncology.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Snoezelen | Experimental | Other: self-report questionnaires, research interviewsParticipants 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- Contraindication to SNOEZELEN:
- State of health not allowing participation in the study (severe fatigue, symptoms refractory to treatment).
- Pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-report questionnaires, research interviewsself-report questionnaires and research interviews | Other | Snoezelen |
Primary outcome
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
Interview with a research psychologist to find out how teenage children feel
8 secondary outcomes
Generalized Anxiety Disorder - GAD-7
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
Anti-emetic treatments
Time frame: Periprocedural
Child-Self Report - PedsQL
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
Number of vomits
Time frame: Periprocedural
Anxiolytic treatments
Time frame: Periprocedural
BARF scale (Baxter Retching Faces)
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
Children's Depression Inventory - CDI
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
Child Anxiety Related Emotional Disorders - SCARED
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-report questionnaires, research interviews in people with Snoezelen and Pediatric Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanny BEN OUNE (+33320295918, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.