Virtual Reality for Children in Radiotherapy (REVER)

NCT04934293 | Recruiting DMC

• 1 other identifier: 2020/04
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Proton Therapy; Pediatric Cancer

Outcome Measures

Primary Outcomes (2)

• Impact of sedation

  The first co-primary endpoint of the study is the measurement of the duration of positioning before irradiation; from installation on the table in a lying position to return to the console to start the irradiation (imaging time included). The measurement of this parameter will make it possible to compare the difference in positioning time with and without digital sedation during the first 5 proton therapy sessions.

  2 weeks

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

  The second co-primary endpoint of the study is the comparison of the difference in positioning time over the first 10 sessions when the virtual reality headset is used from the first session or when it is used from the sixth proton therapy session

  2 weeks

Secondary Outcomes (2)

• Change in anxiety before irradiation

  2 weeks

• The tolerance of the virtual reality procedure

  2 weeks

Study Arms (2)

Arm A_ first with RV then without

EXPERIMENTAL

Use of the virtual reality headset from the first week of proton therapy

Procedure: Virtual reality

Arm B- first without RV than with

EXPERIMENTAL

Use of the virtual reality headset from the second week of proton therapy

Procedure: Virtual reality

Interventions

Virtual reality PROCEDURE

Before proton therapy, virtual reality sessions will be performed.

Arm A_ first with RV then without; Arm B- first without RV than with

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Amandine STARZYK

CONTACT

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

Pierre-Yves BONDIAU, M.D, PhD

CONTACT

04-92-03-12-73; pierre-yves.bondiau@nice.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, monocentric, randomized (1:1), stratified, cross-group cohort study (cross-over), comparing the use of the virtual reality headset from the first session (Arm A) versus the use of the virtual reality from the sixth session (Arm B) of proton therapy.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: August 2, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)