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Clinical Trial NCT04934293 (REVER) for Virtual Reality, Proton Therapy, Pediatric Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Virtual Reality for Children in Radiotherapy (REVER) 47 Pediatric Virtual

Recruiting
Clinical Trial NCT04934293 (REVER) is an interventional study for Virtual Reality, Proton Therapy, Pediatric Cancer that is recruiting. It started on 2 August 2021 with plans to enroll 47 participants. Led by Centre Antoine Lacassagne, it is expected to complete by 1 February 2027. The latest data from ClinicalTrials.gov was last updated on 7 May 2025.
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 tre...

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Detailed Description
The treatment of certain pediatric cancers requires irradiation. These treatments are stressful in children because it is necessary to keep a fixed position that is often uncomfortable. The more the stress increases, the longer the positioning, which again generates stress making the treatment position more and more uncomfortable. This irradiation can be carried out by various conventional techniques, tomotherapy, pr...Show More
Official Title

Virtual Reality for Children in Radiotherapy (REVER)

Conditions
Virtual RealityProton TherapyPediatric Cancer
Other Study IDs
  • REVER
  • 2020/04
NCT ID Number
NCT04934293
Start Date (Actual)
2021-08-02
Last Update Posted
2025-05-07
Completion Date (Estimated)
2027-02
Enrollment (Estimated)
47
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalArm A_ first with RV then without
Use of the virtual reality headset from the first week of proton therapy
Virtual Reality
Before proton therapy, virtual reality sessions will be performed.
ExperimentalArm B- first without RV than with
Use of the virtual reality headset from the second week of proton therapy
Virtual Reality
Before proton therapy, virtual reality sessions will be performed.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in anxiety before irradiation
The measurement before each irradiation session of the anxiety in the child using the EVAN questionnaire. Measuring this parameter will assess: the difference in anxiety before irradiation with and without digital sedation
2 weeks
The tolerance of the virtual reality procedure
The evaluation of the tolerance of the virtual reality procedure before the proton therapy session by recording the appearance and intensity of an adverse event during the digital sedation session, mainly headache, drowsiness, dizziness, anxiety, creation of false memories, dizziness, eye or muscle twitching or loss of consciousness on light stimulation, eye strain, impaired vision, disorientation, imbalance, coordination disorder, panic or anxiety attack, nausea, vomiting. The toxicities will be reported in the evaluation grid.
2 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
7 Years
Eligible Sexes
All
  • 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.

  • 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.
Centre Antoine Lacassagne logoCentre Antoine Lacassagne
Study Central Contact
Contact: Amandine STARZYK, 04-92-03-10-75, [email protected]
Contact: Pierre-Yves BONDIAU, M.D, PhD, 04-92-03-12-73, [email protected]
1 Study Locations in 1 Countries
Centre Antoine Lacassagne, Nice, France
Amandine STARZYK, Contact, [email protected]
Recruiting