NCT04934293 Virtual Reality for Children in Radiotherapy (REVER)
| NCT ID | NCT04934293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Antoine Lacassagne |
| Condition | Virtual Reality |
| Study Type | INTERVENTIONAL |
| Enrollment | 47 participants |
| Start Date | 2021-08-02 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 47 participants in total. It began in 2021-08-02 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
For a young patient, the conditions of proton therapy treatment can be stressful. Adjusting the environment can be a source of avoiding this physical and psychological discomfort impacting the quality of treatment. A fixed, long, uncomfortable position is the main cause of stress, already present due to the cancerous therapeutic course. It extends the positioning time. For the patient and the optimization of his treatment, solutions must be sought. Relaxation in virtual reality is efficient, simple and non-medicinal and could reduce stress in children and allow irradiation in very good conditions. We will assess the effectiveness of the virtual reality session using objective (placement time, helmet tolerance) and subjective (perceived anxiety via a dedicated questionnaire) criteria. This is the first pediatric virtual reality study, supported by the French Group of Pediatric Radiotherapists, to reduce anxiety in radiotherapy. Multiple benefits from this pilot study are expected, such as improved reception conditions, treatment parameters and better acceptance of proton therapy sessions.
Eligibility Criteria
Inclusion Criteria: * Patient treated at the Antoine LACASSAGNE Center for treatment by proton therapy * Age ≥ 7 years old and ≤ 18 years old * Patient, and parents for minor children, having read the information notice and signed the informed consent, * Patient with social security coverage. Exclusion Criteria: * Age \< 7 years old and \> 18 years old, * Patient under general anesthesia, * Patient suffering from wounds or infections in the head, deemed incompatible with the use of the helmet by the investigator, * Patient suffering from respiratory problems, * Patient suffering from a high level of claustrophobia, * Patient followed for a psychiatric pathology, * Patient suffering from unbalanced epilepsy, * Patient suffering from visual (binocular vision) and / or hearing disorders preventing the use of virtual reality, * Patient whose head circumference is insufficient for the use of the helmet, deemed incompatible with the use of the helmet by the investigator, * Patient treated by radio chemotherapy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04934293 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 18 Years, studying Virtual Reality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04934293 currently recruiting?
Yes, NCT04934293 is actively recruiting participants. Contact the research team at amandine.starzyk@nice.unicancer.fr for enrollment information.
Where is the NCT04934293 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT04934293 clinical trial?
NCT04934293 is sponsored by Centre Antoine Lacassagne. The trial plans to enroll 47 participants.