Virtual RealityREVERNCT04934293
Virtual Reality for Children in Radiotherapy (REVER)
A study testing Virtual reality in people with Virtual Reality and Proton Therapy, run by Centre Antoine Lacassagne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Virtual Reality, Proton Therapy, Pediatric Cancer
- What is being tested?
- Virtual reality
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2021to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Antoine Lacassagne
Nice
Amandine STARZYK, amandine.starzyk@nice.unicancer.fr
About this study
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.
Read more
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.
Read the 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, proton therapy. In all cases, the precise positioning, essential for the successful completion of the treatment, under the treatment machine is an iterative process, requiring long and tedious checks. This positioning step on the treatment table takes about 15 minutes, but depending on the technical difficulty can be extended up to 45 minutes in the most complex cases and depending on the patient's apprehension. This positioning is then checked by placement verification images.
At the Antoine LACASSAGNE Center, the investigators have a new generation proton therapy device. This device allows radiotherapy doses to be delivered extremely precisely, subject to very rigorous positioning, and is therefore particularly suitable for pediatric treatment by protecting organs near the radiation. In addition, proton therapy requires longer sessions than conventional radiotherapy; which generates even more anxiety for the children for whom it is the treatment of choice. Non-drug solutions to reduce this stress are therefore necessary to allow the irradiation to be carried out under optimal conditions in order to ensure the effectiveness and safety of the treatment. In this context, virtual reality (VR) headsets, using relaxation techniques in virtual reality or digital sedation, are presented as a simple solution to reduce the anxiety of children regarding the treatment and would therefore be tested mainly on this modality.
To allow us to assess the effectiveness of this technique on anxiety, the investigators will therefore measure the positioning time necessary before carrying out a treatment session and its reduction via its impact on perceived anxiety thanks to a dedicated questionnaire.
The strength of our study is that it uses simple and reproductive measurement systems such as the measurement of placement time and a validated anxiety scale during Marie POURCHET's science thesis. This is the easy EVAN (Anxiety Assessment) scale adapted to several age groups and developed in pediatric wards.
- Conditions
- Virtual Reality, Proton Therapy, Pediatric Cancer
- Being tested
- Virtual reality
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityProcedure or surgery
Before proton therapy, virtual reality sessions will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Arm A_ first with RV then without | Experimental | Use of the virtual reality headset from the first week of proton therapy Receives: Procedure: Virtual reality |
| Arm B- first without RV than with | Experimental | Use of the virtual reality headset from the second week of proton therapy Receives: Procedure: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 weeks
Secondary outcomes (2)
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
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start2 Aug 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934293
- Sponsor's protocol ID
- 2020/04
- Acronym
- REVER
- Status last verified
- May 2026
- First submitted
- 14 Jun 2021
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Children in Radiotherapy (REVER)
- ClinicalTrials.gov ID
- NCT04934293
- Acronym / sponsor ID
- REVER / 2020/04
- Conditions
- Virtual Reality, Proton Therapy, Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, proton therapy. In all cases, the precise positioning, essential for the successful completion of the treatment, under the treatment machine is an iterative process, requiring long and tedious checks. This positioning step on the treatment table takes about 15 minutes, but depending on the technical difficulty can be extended up to 45 minutes in the most complex cases and depending on the patient's apprehension. This positioning is then checked by placement verification images.
At the Antoine LACASSAGNE Center, the investigators have a new generation proton therapy device. This device allows radiotherapy doses to be delivered extremely precisely, subject to very rigorous positioning, and is therefore particularly suitable for pediatric treatment by protecting organs near the radiation. In addition, proton therapy requires longer sessions than conventional radiotherapy; which generates even more anxiety for the children for whom it is the treatment of choice. Non-drug solutions to reduce this stress are therefore necessary to allow the irradiation to be carried out under optimal conditions in order to ensure the effectiveness and safety of the treatment. In this context, virtual reality (VR) headsets, using relaxation techniques in virtual reality or digital sedation, are presented as a simple solution to reduce the anxiety of children regarding the treatment and would therefore be tested mainly on this modality.
To allow us to assess the effectiveness of this technique on anxiety, the investigators will therefore measure the positioning time necessary before carrying out a treatment session and its reduction via its impact on perceived anxiety thanks to a dedicated questionnaire.
The strength of our study is that it uses simple and reproductive measurement systems such as the measurement of placement time and a validated anxiety scale during Marie POURCHET's science thesis. This is the easy EVAN (Anxiety Assessment) scale adapted to several age groups and developed in pediatric wards.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A_ first with RV then without | Experimental | Procedure: Virtual realityUse of the virtual reality headset from the first week of proton therapy |
| Arm B- first without RV than with | Experimental | Procedure: Virtual realityUse of the virtual reality headset from the second week of proton therapy |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityBefore proton therapy, virtual reality sessions will be performed. | Procedure or surgery | Arm A_ first with RV then without, Arm B- first without RV than with |
Primary outcome
Impact of sedation
Time frame: 2 weeks
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.
Benefits of using the virtual reality headset from the first proton therapy session
Time frame: 2 weeks
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 secondary outcomes
Change in anxiety before irradiation
Time frame: 2 weeks
The tolerance of the virtual reality procedure
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Virtual Reality and Proton Therapy, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amandine STARZYK (04-92-03-10-75 ext. +33, amandine.starzyk@nice.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of sedation (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.