Suspected EndometriosisENDOREVNCT06655584
ENDOREV: A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis?
A study testing Virtual reality headset Bliss DTX in people with Suspected Endometriosis, run by Poissy-Saint Germain Hospital at 1 site in France.
Trial summary
The aim of the research is to evaluate the effectiveness of virtual reality on the anxiety of patients with suspected endometriosis in gynecological consultation. Indeed, several studies prove that patients in this situation are anxious. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Suspected Endometriosis
- What is being tested?
- Virtual reality headset Bliss DTX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2024to Nov 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patient between 18 and 45 years old
- Patient referred for suspected endometriosis
- Patient consulting for the first time in the hospital
- Patient with first-line or second-line imaging documenting endometriosis (ultrasound or MRI)
- Patient agreeing to participate in the study and having signed informed consent
- Patient affiliated to a social security scheme
- Patient able to read and write French
Who cannot join
- • Patient with a history of major pelvic surgery for endometriosis
- Patient undergoing hysterectomy
- Virgin patient
- Pregnant woman
- Patient with psychiatric pathology
- Patient suffering from proven epilepsy
Show all 10Show fewer
- Patient under judicial protection
- Patient under guardianship or curatorship
- Patient with visual or hearing impairment
- Patient with a progressive pathology responsible for chronic pain
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
Poissy-Saint Germain Hospital
Poissy, 78300
Elise LUNELLI, +33139274581, elise.lunelli@ght-yvelinesnord.fr
LUNELLI
About this study
The aim of the research is to evaluate the effectiveness of virtual reality on the anxiety of patients with suspected endometriosis in gynecological consultation.
Indeed, several studies prove that patients in this situation are anxious. We would like to offer help in reducing anxiety in this case by means of digital therapy.
Read more
As part of this study, the equipment used will be "Bliss DTX". This is a non-drug digital therapy (digital therapeutics) already used in various hospital departments.
Bliss DTX immerses patients in sound and image programs scientifically developed for their effect on pain and anxiety, mobilizing their abilities and placing them in an altered state of consciousness. Bliss DTX software is delivered to patients via a dedicated video headset (virtual reality) and audio headset, as part of an integrated solution.
Conduct of the study:
The patient will be taken care of on the day of the consultation by a clinical research nurse. It will be installed in a reception room in the consultation room. The nurse will give him a questionnaire on anxiety to complete before the consultation.
A draw will be carried out with two options:
- Bliss DTX digital therapy via audio and video headphones lasting 13 minutes
- Installation in the reception room while waiting for the doctor to arrive. After the consultation, the patient will complete a new questionnaire on her state of anxiety and her feelings during the consultation.
A telephone call will be made 6 months after the consultation to collect post-consultation information.
Duration :
Duration of 6 months on 46 patients followed for 18 months. Expected benefits
- Reduction of anxiety after consultation by diversion of attention
- Strengthening the bond of trust between the patient and the care team
- Better monitoring and better compliance with treatment and medical examinations
- Better pain management
- Improved quality of life
Possible side effects:
No particular risks or constraints, however, a virtual reality headset can cause symptoms such as: nausea, dizziness, sweating, paleness, balance disorders grouped under the term "cybernetosis" as well as epileptic seizures in people. subjects predisposed to convulsions.
Read the detailed description
Title :
ENDOREV: A solution to reduce anxiety during gynecological consultations in patients with suspected endometriosis?
Description of the study :
Single-center, randomized, controlled, open-label interventional study on two parallel groups Study composed of 46 patients randomized into two groups A and B with a ratio of 1:1 Experimental Group A: The patient will be installed in a reception room and will benefit from Bliss DTx digital therapy via a video headset and an audio headset for a duration of 13 minutes Group B control: The patient will be seated and wait for the doctor to arrive (no material) The duration of inclusion is 18 months and individual participation is 6 months, that is to say 24 months for the entire study.
Completion of the questionnaire (IASTA Y-1) for both groups before the consultation and data collection.
Filling of the CRF in consultation by the doctor Completion of the questionnaire (IASTA Y-1) for both arms after the consultation and data collection Telephone call at 6 months with data collection on compliance with endometriosis monitoring
Objectives :
Primary objectives :
- Evaluate the effectiveness of virtual reality on anxiety in women with suspected endometriosis during the gynecological consultation.
Secondary objectives :
- Study the effect of virtual reality on compliance with endometriosis monitoring following the gynecological consultation
- Evaluate the effect of virtual reality on the pain felt during the gynecological examination
- Evaluate the level of satisfaction with the device during the session
Hypothesis :
- Null hypothesis (H0): No significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores
- Alternative hypothesis (H1): There is a significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores.
Inclusion criteria :
- Patient between 18 and 45 years old
- Patient referred for suspected endometriosis
- Patient consulting for the first time in the hospital
- Patient with first-line or second-line imaging documenting endometriosis (ultrasound or MRI)
- Patient agreeing to participate in the study and having signed informed consent
- Patient affiliated to a social security scheme
- Patient able to read and write French
Exclusion criteria:
- Patient with a history of major pelvic surgery for endometriosis
- Patient undergoing hysterectomy
- Virgin patient
- Pregnant woman
- Patient with psychiatric pathology
- Patient suffering from proven epilepsy
- Patient under judicial protection
- Patient under guardianship or curatorship
- Patient with visual or hearing impairment
- Patient with a progressive pathology responsible for chronic pain
Place of the study :
Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye
Contact details :
Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye Address: 10 rue du Champ Gaillard, 78300 Poissy Tel: +33139274581 Email: elise.lunelli@ght-yvelinesnord.fr
Speakers :
- Promoter: Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye
- Coordinating investigator: Ms. Elise LUNELLI (registered nurse)
Funding :
GIRCI IDF and ARS IDF funding as part of the call for projects " Appel à projets recherche en soins (APRESO) "2024
Calendar :
Primary submission : 11/09/24 Secondary submission :26/09/24
- Conditions
- Suspected Endometriosis
- Being tested
- Virtual reality headset Bliss DTX
- Keywords
- endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headset Bliss DTXDevice
The patient will be installed in a reception room and will benefit from Bliss DTx digital therapy via a video headset and an audio headset for a duration of 13 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Experimental Group A: The patient will be installed in a reception room and will benefit from Bliss DTx digital therapy via a video headset and an audio headset for a duration of 13 minutes Receives: Device: Virtual reality headset Bliss DTX |
| group B | No intervention | Group B control: The patient will be installed in a reception room and will be seated and wait for the doctor to arrive (no material) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants showing a reduction in post-consultation anxiety
Measured: Pre-consultation until post-consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start22 Oct 2024
- Primary completionMay 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected EndometriosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, controlled, open-label interventional study on two parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- French Interregional Group of Clinical Research and Innovation
- Responsible party
- Principal investigator, Elise LUNELLI, Poissy-Saint Germain Hospital
- Investigators
- Arnaud FAUCONNIER, PROFESSOR, Study chair, Pr FAUCONNIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655584
- Sponsor's protocol ID
- 2024-A01166-41
- Acronym
- ENDOREV
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with the provisions of the law relating to data processing, files and freedoms (law 78-17 of January 6, 1978 as amended) and the general data protection regulation (EU) 2016/679 (GDPR), the patient has a right to object at any time to the processing of their data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOREV: A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis?
- ClinicalTrials.gov ID
- NCT06655584
- Acronym / sponsor ID
- ENDOREV / 2024-A01166-41
- Conditions
- Suspected Endometriosis
- Keywords
- endometriosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Collaborators
- French Interregional Group of Clinical Research and Innovation
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Oct 2024 (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.
The aim of the research is to evaluate the effectiveness of virtual reality on the anxiety of patients with suspected endometriosis in gynecological consultation.
Indeed, several studies prove that patients in this situation are anxious. We would like to offer help in reducing anxiety in this case by means of digital therapy.
As part of this study, the equipment used will be "Bliss DTX". This is a non-drug digital therapy (digital therapeutics) already used in various hospital departments.
Bliss DTX immerses patients in sound and image programs scientifically developed for their effect on pain and anxiety, mobilizing their abilities and placing them in an altered state of consciousness. Bliss DTX software is delivered to patients via a dedicated video headset (virtual reality) and audio headset, as part of an integrated solution.
Conduct of the study:
The patient will be taken care of on the day of the consultation by a clinical research nurse. It will be installed in a reception room in the consultation room. The nurse will give him a questionnaire on anxiety to complete before the consultation.
A draw will be carried out with two options:
- Bliss DTX digital therapy via audio and video headphones lasting 13 minutes
- Installation in the reception room while waiting for the doctor to arrive. After the consultation, the patient will complete a new questionnaire on her state of anxiety and her feelings during the consultation.
A telephone call will be made 6 months after the consultation to collect post-consultation information.
Duration :
Duration of 6 months on 46 patients followed for 18 months. Expected benefits
- Reduction of anxiety after consultation by diversion of attention
- Strengthening the bond of trust between the patient and the care team
- Better monitoring and better compliance with treatment and medical examinations
- Better pain management
- Improved quality of life
Possible side effects:
No particular risks or constraints, however, a virtual reality headset can cause symptoms such as: nausea, dizziness, sweating, paleness, balance disorders grouped under the term "cybernetosis" as well as epileptic seizures in people. subjects predisposed to convulsions.
Detailed description
Title :
ENDOREV: A solution to reduce anxiety during gynecological consultations in patients with suspected endometriosis?
Description of the study :
Single-center, randomized, controlled, open-label interventional study on two parallel groups Study composed of 46 patients randomized into two groups A and B with a ratio of 1:1 Experimental Group A: The patient will be installed in a reception room and will benefit from Bliss DTx digital therapy via a video headset and an audio headset for a duration of 13 minutes Group B control: The patient will be seated and wait for the doctor to arrive (no material) The duration of inclusion is 18 months and individual participation is 6 months, that is to say 24 months for the entire study.
Completion of the questionnaire (IASTA Y-1) for both groups before the consultation and data collection.
Filling of the CRF in consultation by the doctor Completion of the questionnaire (IASTA Y-1) for both arms after the consultation and data collection Telephone call at 6 months with data collection on compliance with endometriosis monitoring
Objectives :
Primary objectives :
- Evaluate the effectiveness of virtual reality on anxiety in women with suspected endometriosis during the gynecological consultation.
Secondary objectives :
- Study the effect of virtual reality on compliance with endometriosis monitoring following the gynecological consultation
- Evaluate the effect of virtual reality on the pain felt during the gynecological examination
- Evaluate the level of satisfaction with the device during the session
Hypothesis :
- Null hypothesis (H0): No significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores
- Alternative hypothesis (H1): There is a significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores.
Inclusion criteria :
- Patient between 18 and 45 years old
- Patient referred for suspected endometriosis
- Patient consulting for the first time in the hospital
- Patient with first-line or second-line imaging documenting endometriosis (ultrasound or MRI)
- Patient agreeing to participate in the study and having signed informed consent
- Patient affiliated to a social security scheme
- Patient able to read and write French
Exclusion criteria:
- Patient with a history of major pelvic surgery for endometriosis
- Patient undergoing hysterectomy
- Virgin patient
- Pregnant woman
- Patient with psychiatric pathology
- Patient suffering from proven epilepsy
- Patient under judicial protection
- Patient under guardianship or curatorship
- Patient with visual or hearing impairment
- Patient with a progressive pathology responsible for chronic pain
Place of the study :
Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye
Contact details :
Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye Address: 10 rue du Champ Gaillard, 78300 Poissy Tel: +33139274581 Email: elise.lunelli@ght-yvelinesnord.fr
Speakers :
- Promoter: Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye
- Coordinating investigator: Ms. Elise LUNELLI (registered nurse)
Funding :
GIRCI IDF and ARS IDF funding as part of the call for projects " Appel à projets recherche en soins (APRESO) "2024
Calendar :
Primary submission : 11/09/24 Secondary submission :26/09/24
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, controlled, open-label interventional study on two parallel groups
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Virtual reality headset Bliss DTXExperimental Group A: The patient will be installed in a reception room and will benefit from Bliss DTx digital therapy via a video headset and an audio headset for a duration of 13 minutes |
| group B | No intervention | –Group B control: The patient will be installed in a reception room and will be seated and wait for the doctor to arrive (no material) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Patient between 18 and 45 years old
Key exclusion criteria (10 listed)
- • Patient with a history of major pelvic surgery for endometriosis
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 headset Bliss DTXThe patient will be installed in a reception room and will benefit from Bliss DTx digital therapy via a video headset and an audio headset for a duration of 13 minutes | Device | Group A |
Primary outcome
Number of participants showing a reduction in post-consultation anxiety
Time frame: Pre-consultation until post-consultation
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 23 Oct 2024.
- Individual participant dataSharing planned: No. In accordance with the provisions of the law relating to data processing, files and freedoms (law 78-17 of January 6, 1978 as amended) and the general data protection regulation (EU) 2016/679 (GDPR), the patient has a right to object at any time to the processing of their data.
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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.
Arnaud FAUCONNIER, PROFESSOR study chair
Pr FAUCONNIER
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 headset Bliss DTX in people with Suspected Endometriosis, run by Poissy-Saint Germain Hospital 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 7 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 23 Oct 2024. 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 Elise LUNELLI (+33139274581, elise.lunelli@ght-yvelinesnord.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants showing a reduction in post-consultation anxiety (time frame: Pre-consultation until post-consultation). 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 23 Oct 2024.