ENDOREV: A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis?

NCT ID: NCT06655584

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2026-11-30

Brief 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. 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:

1. Bliss DTX digital therapy via audio and video headphones lasting 13 minutes

2. 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

Conditions

Suspected Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group A

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 Type: EXPERIMENTAL

Virtual reality headset Bliss DTX

Intervention Type: DEVICE

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

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality headset Bliss DTX

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

French Interregional Group of Clinical Research and Innovation

OTHER

Sponsor Role: collaborator

Poissy-Saint Germain Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elise LUNELLI

research nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arnaud FAUCONNIER, PROFESSOR

Role: STUDY_CHAIR

Pr FAUCONNIER

Locations

Poissy-Saint Germain Hospital

Poissy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Elise LUNELLI

Role: CONTACT

elise.lunelli@ght-yvelinesnord.fr

+33139274581

Facility Contacts

Elise LUNELLI

Role: primary

elise.lunelli@ght-yvelinesnord.fr

+33139274581

Other Identifiers

2024-A01166-41

Identifier Type: -

Identifier Source: org_study_id