Breast CancerREAVANCT05269186
Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy
A study testing Virtual reality software in people with Breast Cancer and Pelvic Cancer, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
In France, according to the National Cancer Institute, it appears that treatments in radiotherapy centers for cancer will increase from 198,000 in 2015 to 239,000 in 2030: this represents 40,000 additional treatments in 15 years. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Breast Cancer, Pelvic Cancer
- What is being tested?
- Virtual reality software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2022to 4 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an indication for first radiotherapy treatment for breast or pelvic cancer (prostate, rectum, endometrium, anal canal and cervix)
- Patient ≥ 18 years old,
- Patient who has the capacity to understand the protocol and has given written consent to participate in the research,
- Patient with social security coverage.
Who cannot join
- Metastatic patients
- Patients with previous radiotherapy
- Patients with a diagnosis of hearing impairment
- Patients with major cognitive disorders (such as dementia)
- Psychiatric pathology such as schizophrenia
- Patients with epilepsy or hypersensitivity to flashing lights
Show all 17Show fewer
- Patient with a pacemaker, hearing aid or defibrillator
- Claustrophobic patients
- Patients sensitive to motion sickness
- Patients who are visually impaired or blind
- Patients with migraine
- Patients with skin defects and open wounds in the area where the helmet is applied (face or scalp) or in the eyes
- Patients under guardianship, curators or deprived of liberty
- Non French speaking patient
- Illiterate patient
- Patient participating in another clinical investigation or interventional clinical research protocol involving a drug
- Pregnant or breastfeeding patient
Trial locations and contacts
1 site in 1 country.
About this study
In France, according to the National Cancer Institute, it appears that treatments in radiotherapy centers for cancer will increase from 198,000 in 2015 to 239,000 in 2030: this represents 40,000 additional treatments in 15 years.
A meta-analysis on radiotherapy indicated that 10 to 20% of patients had clinically significant levels of anxiety at the beginning of radiotherapy.
Read more
Indeed, several factors generate this tension, above all the new or unfamiliar environment, the imposing and noisy scanner, the restraints that are difficult to bear or the nudity required for the examination.
This anxiety has an impact on performance of the planning CT scan examination, an essential step for the future treatment.
The radiotherapy unit of the Centre Hospitalier Departemental de Vendee has put in place resources to reduce anxiety felt during treatment sessions (music therapy, conversational hypnosis, sophrology or aromatherapy). However, nothing has been put in place to reduce the anxiety of patients in the period preceding the planning CT scan.
Virtual reality software seems to be a good alternative that requires fewer human resources.
The research hypothesis is that patients who have benefited from the virtual reality software will have a lower level of anxiety before the planning CT scan than patients who have not benefited from virtual reality.
- Conditions
- Breast Cancer, Pelvic Cancer
- Being tested
- Virtual reality software
- Medical subject headings
- Breast Neoplasms, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality softwareDevice
The patient will undergo a 20-minute virtual reality session before the planning CT scan
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Virtual reality session performed before the planning CT scan Receives: Device: Virtual reality software |
| Normal care | No intervention | Normal care without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the Anxiety of the Patient Benefiting From a Virtual Reality Session Versus Normal Care Management
Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
Measured: 10 minute before the planning CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start5 Oct 2022
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa ZINZONI, Principal investigator, vanessa.zinzoni@ght85.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269186
- Sponsor's protocol ID
- CHD22_0002
- Acronym
- REAVA
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2022
- Last updated
- 18 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy
- ClinicalTrials.gov ID
- NCT05269186
- Acronym / sponsor ID
- REAVA / CHD22_0002
- Conditions
- Breast Cancer, Pelvic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Posted 18 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In France, according to the National Cancer Institute, it appears that treatments in radiotherapy centers for cancer will increase from 198,000 in 2015 to 239,000 in 2030: this represents 40,000 additional treatments in 15 years.
A meta-analysis on radiotherapy indicated that 10 to 20% of patients had clinically significant levels of anxiety at the beginning of radiotherapy.
Indeed, several factors generate this tension, above all the new or unfamiliar environment, the imposing and noisy scanner, the restraints that are difficult to bear or the nudity required for the examination.
This anxiety has an impact on performance of the planning CT scan examination, an essential step for the future treatment.
The radiotherapy unit of the Centre Hospitalier Departemental de Vendee has put in place resources to reduce anxiety felt during treatment sessions (music therapy, conversational hypnosis, sophrology or aromatherapy). However, nothing has been put in place to reduce the anxiety of patients in the period preceding the planning CT scan.
Virtual reality software seems to be a good alternative that requires fewer human resources.
The research hypothesis is that patients who have benefited from the virtual reality software will have a lower level of anxiety before the planning CT scan than patients who have not benefited from virtual reality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual reality softwareVirtual reality session performed before the planning CT scan |
| Normal care | No intervention | –Normal care without intervention |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with an indication for first radiotherapy treatment for breast or pelvic cancer (prostate, rectum, endometrium, anal canal and cervix)
- Patient ≥ 18 years old,
- Patient who has the capacity to understand the protocol and has given written consent to participate in the research,
- Patient with social security coverage.
Key exclusion criteria (17 listed)
- Metastatic patients
- Patients with previous radiotherapy
- Patients with a diagnosis of hearing impairment
- Patients with major cognitive disorders (such as dementia)
- Psychiatric pathology such as schizophrenia
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 reality softwareThe patient will undergo a 20-minute virtual reality session before the planning CT scan | Device | Virtual reality |
Primary outcome
Evaluating the Anxiety of the Patient Benefiting From a Virtual Reality Session Versus Normal Care Management
Time frame: 10 minute before the planning CT scan
Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vanessa ZINZONI principal investigator
vanessa.zinzoni@ght85.fr
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 software in people with Breast Cancer and Pelvic Cancer, run by Centre Hospitalier Departemental Vendee 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 17 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: finished, as of the sponsor's last update on 18 Jun 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?
Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the Anxiety of the Patient Benefiting From a Virtual Reality Session Versus Normal Care Management (time frame: 10 minute before the planning CT scan). 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 18 Jun 2026.