Bronchial FibroscopyREVANCT06799806
The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil
A study testing virtual reality device in people with Bronchial Fibroscopy, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
Bronchial fibroscopy is a frequently used procedure in the management of pneumology patients, and can be a source of anxiety, particularly while waiting for the examination. Investigator's professional experience has shown us that many patients are anxious in the waiting room before a flexible bronchoscopy in vigile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Fibroscopy
- What is being tested?
- virtual reality device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2025to 27 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with no age or gender restrictions, seen on an outpatient basis at Le Mans Hospital.
- In whom bronchial fibroscopy is indicated.
- Person affiliated with or benefiting from a social security .
- Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
- Patient able and willing to answer questionnaires
Who cannot join
- Patient refusing to participate in research
- Patient who has already undergone bronchoscopy in vigil
- Patient premedicated for bronchial fibroscopy (anxiolytic, etc.)
- Patients with a history of epilepsy or psychiatric pathology
- Patient with vertigo
- Patient uncooperative, demented or unable to tolerate headgear.
Show all 12Show fewer
- patient under guardianship or curatorship
- Patients suffering from blindness or deafness
- Patient with known significant intolerance to screens and/or virtual reality devices
- Pregnant, nursing or parturient women
- Unscheduled patients: emergencies, etc.
- Hospitalized patients
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 Hospitalier Le Mans
Le Mans, 72000
Christelle JADEAU, MD, +332 44 71 07 81, cjadeau@ch-lemans.fr
Christine PETIT
About this study
Bronchial fibroscopy is a frequently used procedure in the management of pneumology patients, and can be a source of anxiety, particularly while waiting for the examination.
Investigator's professional experience has shown us that many patients are anxious in the waiting room before a flexible bronchoscopy in vigile.
A great deal of research has been carried out into the use of virtual reality to reduce anxiety and pain during care but shortly before bronchoscopy. The innovative aspect is to target the patient's waiting time for the examination. Waiting is a highly anxiety-provoking time, and nurses play a vital role in supporting patients.
- Conditions
- Bronchial Fibroscopy
- Being tested
- virtual reality device
- Keywords
- virtual reality headset, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality deviceDevice
20 minutes session with virtual reality device
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | virtual reality headset Receives: Device: virtual reality device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety assessment
Anxiety assessment is measured using a Numerical Rating Scale (NRS) from 0 to 10, supplemented by a self-assessment questionnaire before and after using the Therapeutic Virtual Reality Headset.
Measured: Immediately after intervention
Secondary outcomes (1)
Assessment of bronchoscopy realisation and sample collection
Assessment of whether bronchoscopy has been performed correctly in the vigile state, aas well as any sampling required, using a questionnaire completed by the nurse present during vigile flexible bronchoscopy.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start27 Feb 2025
- Primary completion27 Feb 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial FibroscopyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-center, prospective, interventional study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine PETIT, Principal investigator, Centre Hospitalier le Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799806
- Sponsor's protocol ID
- CHM-2024/S15/04
- Acronym
- REVA
- Status last verified
- Mar 2025
- First submitted
- 20 Jan 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil
- ClinicalTrials.gov ID
- NCT06799806
- Acronym / sponsor ID
- REVA / CHM-2024/S15/04
- Conditions
- Bronchial Fibroscopy
- Keywords
- virtual reality headset, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 29 Jan 2025 (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.
Bronchial fibroscopy is a frequently used procedure in the management of pneumology patients, and can be a source of anxiety, particularly while waiting for the examination.
Investigator's professional experience has shown us that many patients are anxious in the waiting room before a flexible bronchoscopy in vigile.
A great deal of research has been carried out into the use of virtual reality to reduce anxiety and pain during care but shortly before bronchoscopy. The innovative aspect is to target the patient's waiting time for the examination. Waiting is a highly anxiety-provoking time, and nurses play a vital role in supporting patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center, prospective, interventional study
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Device: virtual reality devicevirtual reality headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with no age or gender restrictions, seen on an outpatient basis at Le Mans Hospital.
- In whom bronchial fibroscopy is indicated.
- Person affiliated with or benefiting from a social security .
- Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
- Patient able and willing to answer questionnaires
Key exclusion criteria (12 listed)
- Patient refusing to participate in research
- Patient who has already undergone bronchoscopy in vigil
- Patient premedicated for bronchial fibroscopy (anxiolytic, etc.)
- Patients with a history of epilepsy or psychiatric pathology
- Patient with vertigo
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 device20 minutes session with virtual reality device | Device | virtual reality |
Primary outcome
Anxiety assessment
Time frame: Immediately after intervention
Anxiety assessment is measured using a Numerical Rating Scale (NRS) from 0 to 10, supplemented by a self-assessment questionnaire before and after using the Therapeutic Virtual Reality Headset.
1 secondary outcome
Assessment of bronchoscopy realisation and sample collection
Time frame: Immediately after intervention
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 24 Mar 2025.
- Individual participant dataSharing planned: No
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.
Christine PETIT principal investigator
Centre Hospitalier le Mans
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 device in people with Bronchial Fibroscopy, run by Centre Hospitalier le Mans 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 5 inclusion and 12 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 24 Mar 2025. 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 Christelle JADEAU (+332 44 71 07 81, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety assessment (time frame: Immediately after intervention). 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 24 Mar 2025.