RecruitingNot Applicable

Virtual Reality for Children in Radiotherapy (REVER)

France47 participantsStarted 2021-08-02

Plain-language 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.

Who can participate

Age range

7 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Impact of sedation

Timeframe: 2 weeks

Benefits of using the virtual reality headset from the first proton therapy session

Timeframe: 2 weeks

Trial details

NCT IDNCT04934293

SponsorCentre Antoine Lacassagne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Amandine STARZYK

04-92-03-10-75 amandine.starzyk@nice.unicancer.fr

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