EndoscopyCARVENDONCT06999525
Use of Virtual Reality Technologies in Management of Anxiety and Discomfort During Endoscopy Procedure
A study testing Therapeutic virtual reality headset (CRVT) in people with Endoscopy, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Digestive endoscopies are performed either for diagnostic purposes (e.g. suspicion of cancer or monitoring of chronic diseases) or for therapeutic purposes (treatment of digestive haemorrhage, removal of polyps, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopy
- What is being tested?
- Therapeutic virtual reality headset (CRVT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years (adult patients)
- Affiliated with a French social security system
- No legal protection measures (e.g., guardianship, curatorship)
- Scheduled for outpatient digestive endoscopy (upper or lower) under general anesthesia, level 1 (excluding biliary or interventional procedures)
- Medical indication for the endoscopic procedure established by a clinician
Who cannot join
- History of epilepsy
- Claustrophobia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Paul Dessaint, MD contact
About this study
Digestive endoscopies are performed either for diagnostic purposes (e.g. suspicion of cancer or monitoring of chronic diseases) or for therapeutic purposes (treatment of digestive haemorrhage, removal of polyps, etc.).
Some endoscopies are performed under local anaesthetic, which can cause considerable anxiety in anticipation of the procedure and considerable discomfort during the procedure. Other endoscopies are performed under general anaesthetic for more extensive procedures on outpatients or inpatients. Anxiety prior to anaesthesia is likely to increase the perception of pain, increase the need for anaesthetic products and thus increase the time to complete awakening.
Read more
Complementary techniques such as hypnotherapy can be used before the operation, with proven effectiveness. But these techniques require dedicated and specifically trained staff, as well as additional time.
Virtual reality technologies, and in particular virtual reality headsets, allow instant immersion in a relaxing world. Therapeutic virtual reality headsets (TRVH) have been shown to be effective in reducing pre-operative anxiety and pain perception.
Our hypothesis is that the use of a CRVT could reduce the consumption of anaesthetic products, reduce anxiety, improve overall satisfaction and reduce the length of outpatient hospitalisation during digestive endoscopy procedures.
Read the detailed description
This is a single-centre randomised controlled trial. The aim is to compare total propofol consumption between patients who have benefited from CRVT immersion and control patients.
All consecutive eligible patients will be informed of the study and invited to participate, by the prescribing physicians, in consultation or during hospitalisation as part of their care. The presentation of the research will also include a demonstration of the use of the CRVT in the digestive endoscopy department.
Patients who agree to take part will be included on the day of the procedure and randomised immediately afterwards by the doctor performing the endoscopy, in a 1:1 ratio, using a secure web server.
Patients randomised to the experimental arm will receive CRVT pre-operatively. Pre-operative anxiety (STAI) will be measured on two occasions: on arrival in the endoscopy department (at reception) and before the endoscopic procedure (in the endoscopy room).
Sedation will be provided by IV propofol only, by AIVOC. The depth of sedation will be monitored by measuring the bispectral index (BIS), with the aim of achieving a score of ≤ 75. Maintenance of sedation in the target zone will be achieved by adjusting the target concentration of AIVOC, with a BIS target of between 65 and 75. The time between the end of the procedure and actual awakening will be recorded in the endoscopy room.
Patient satisfaction (quantitative scale from 0 to 100) will be assessed in the outpatient department (during the pre-discharge visit). The time elapsed between the end of the procedure and discharge from the outpatient department will be recorded at the time of discharge.
- Conditions
- Endoscopy
- Being tested
- Therapeutic virtual reality headset (CRVT)
- Keywords
- Endoscopy, Virtual reality technologies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic virtual reality headset (CRVT)Device
Contribution of the use of a Therapeutic Virtual Reality Headset in the management of anxiety and discomfort in digestive endoscopy
| Study group | Role | What they receive |
|---|---|---|
| With virtual reality technologies | Experimental | Patients with virtual reality technologies during endoscopy procedure Receives: Device: Therapeutic virtual reality headset (CRVT) |
| Without virtual reality technologies | No intervention | Routine procedure of endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
total propofol consumption
To compare total propofol consumption between patients who received CRVT immersion and control patients.
Measured: at day 1
Secondary outcomes (4)
Time of awakening
To compare the time to awakening after the end of the procedure between patients who received CRVT immersion and control patients.
Measured: at day 1
patient satisfaction
To compare patient satisfaction with CRVT immersion with that of control patients.
Questionnaire: Visual Analog Scale Patient satisfaction assessed using a 0-100 Visual Analog Scale (VAS) Patient satisfaction will be assessed using a visual analog scale ranging from 0 to 100, where higher scores indicate greater satisfaction (better outcome).
This scale will evaluate the patient's experience regarding:
- Pain
- Nausea
- Anxiety
- Overall satisfaction The questionnaire will be administered in the outpatient unit prior to discharge
Measured: at day 1
post-endoscopy anxiety assessement
To compare pre- and post-endoscopy anxiety in CRVT-immersion patients with that in control patients.
Outcome Measure Description:
Anxiety will be evaluated using the State-Trait Anxiety Inventory - State subscale (STAI-YA), a validated self-report questionnaire composed of 20 items rated on a 4-point Likert scale.
- Score range: 20 (low anxiety) to 80 (high anxiety)
- Interpretation: Higher scores indicate greater anxiety (worse outcome)
The questionnaire will be administered twice:
- Timepoint 1 - Upon arrival in the endoscopy unit (baseline)
- Timepoint 2 - Immediately after the endoscopic procedure (Day 1) The difference in STAI-YA scores before and after the procedure will be compared between patients in the CRVT group and those in the control group
Measured: at baseline and at day 1
Duration of hospitalization
To compare the duration of outpatient hospitalisation between the end of the procedure and discharge of patients who had undergone CRVT immersion with that of control patients
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study startJul 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas BAZIN, MD, PhD, Principal investigator, CHU Ambroise Paré, APHP, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999525
- Sponsor's protocol ID
- APHP231304
- Other IDs
- 2025-A00550-49
- Acronym
- CARVENDO
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality Technologies in Management of Anxiety and Discomfort During Endoscopy Procedure
- ClinicalTrials.gov ID
- NCT06999525
- Acronym / sponsor ID
- CARVENDO / APHP231304
- Conditions
- Endoscopy
- Keywords
- Endoscopy, Virtual reality technologies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 31 May 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.
Digestive endoscopies are performed either for diagnostic purposes (e.g. suspicion of cancer or monitoring of chronic diseases) or for therapeutic purposes (treatment of digestive haemorrhage, removal of polyps, etc.).
Some endoscopies are performed under local anaesthetic, which can cause considerable anxiety in anticipation of the procedure and considerable discomfort during the procedure. Other endoscopies are performed under general anaesthetic for more extensive procedures on outpatients or inpatients. Anxiety prior to anaesthesia is likely to increase the perception of pain, increase the need for anaesthetic products and thus increase the time to complete awakening.
Complementary techniques such as hypnotherapy can be used before the operation, with proven effectiveness. But these techniques require dedicated and specifically trained staff, as well as additional time.
Virtual reality technologies, and in particular virtual reality headsets, allow instant immersion in a relaxing world. Therapeutic virtual reality headsets (TRVH) have been shown to be effective in reducing pre-operative anxiety and pain perception.
Our hypothesis is that the use of a CRVT could reduce the consumption of anaesthetic products, reduce anxiety, improve overall satisfaction and reduce the length of outpatient hospitalisation during digestive endoscopy procedures.
Detailed description
This is a single-centre randomised controlled trial. The aim is to compare total propofol consumption between patients who have benefited from CRVT immersion and control patients.
All consecutive eligible patients will be informed of the study and invited to participate, by the prescribing physicians, in consultation or during hospitalisation as part of their care. The presentation of the research will also include a demonstration of the use of the CRVT in the digestive endoscopy department.
Patients who agree to take part will be included on the day of the procedure and randomised immediately afterwards by the doctor performing the endoscopy, in a 1:1 ratio, using a secure web server.
Patients randomised to the experimental arm will receive CRVT pre-operatively. Pre-operative anxiety (STAI) will be measured on two occasions: on arrival in the endoscopy department (at reception) and before the endoscopic procedure (in the endoscopy room).
Sedation will be provided by IV propofol only, by AIVOC. The depth of sedation will be monitored by measuring the bispectral index (BIS), with the aim of achieving a score of ≤ 75. Maintenance of sedation in the target zone will be achieved by adjusting the target concentration of AIVOC, with a BIS target of between 65 and 75. The time between the end of the procedure and actual awakening will be recorded in the endoscopy room.
Patient satisfaction (quantitative scale from 0 to 100) will be assessed in the outpatient department (during the pre-discharge visit). The time elapsed between the end of the procedure and discharge from the outpatient department will be recorded at the time of discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With virtual reality technologies | Experimental | Device: Therapeutic virtual reality headset (CRVT)Patients with virtual reality technologies during endoscopy procedure |
| Without virtual reality technologies | No intervention | –Routine procedure of endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years (adult patients)
- Affiliated with a French social security system
- No legal protection measures (e.g., guardianship, curatorship)
- Scheduled for outpatient digestive endoscopy (upper or lower) under general anesthesia, level 1 (excluding biliary or interventional procedures)
- Medical indication for the endoscopic procedure established by a clinician
Key exclusion criteria (2 listed)
- History of epilepsy
- 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 |
|---|---|---|
| Therapeutic virtual reality headset (CRVT)Contribution of the use of a Therapeutic Virtual Reality Headset in the management of anxiety and discomfort in digestive endoscopy | Device | With virtual reality technologies |
Primary outcome
total propofol consumption
Time frame: at day 1
To compare total propofol consumption between patients who received CRVT immersion and control patients.
4 secondary outcomes
Time of awakening
Time frame: at day 1
patient satisfaction
Time frame: at day 1
post-endoscopy anxiety assessement
Time frame: at baseline and at day 1
Duration of hospitalization
Time frame: at day 1
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 31 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Endoscopy
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
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.
Paul Dessaint, MD contact
Thomas BAZIN, MD, PhD principal investigator
CHU Ambroise Paré, APHP, France
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic virtual reality headset (CRVT) in people with Endoscopy, run by Assistance Publique - Hôpitaux de Paris.
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 2 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: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Thomas BAZIN, MD, PhD (33 + 01 40 87 57 95, thomas.bazin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total propofol consumption (time frame: at day 1). 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 31 May 2025.