Virtual Reality for Children in Radiotherapy (REVER)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorCentre Antoine Lacassagne
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Crossover
Treatments tested in this trial
Virtual reality
Procedure/SurgeryBefore proton therapy, virtual reality sessions will be performed.
Treatment groups
47 Participants
are divided into 2 treatment groupsGroup A: Arm A_ first with RV then withoutExperimental treatment 1 intervention
Group B: Arm B- first without RV than withExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 weeks2
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
Time frame
2 weeksSecondary outcomes
1
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
Time frame
2 weeks2
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.
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov