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

NCT06655584 | Recruiting

• 1 other identifier: 2024-A01166-41
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Suspected Endometriosis

Keywords

endometriosis

Outcome Measures

Primary Outcomes (1)

• Number of participants showing a reduction in post-consultation anxiety

  Pre-consultation until post-consultation

Study Arms (2)

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

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)

Interventions

Virtual reality headset Bliss DTX 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 A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poissy-Saint Germain Hospital: lead
• French Interregional Group of Clinical Research and Innovation: collaborator

Study Sites (1)

Poissy-Saint Germain Hospital

Poissy, 78300, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Arnaud FAUCONNIER, PROFESSOR

  Pr FAUCONNIER

  STUDY CHAIR

Central Study Contacts

Elise LUNELLI

CONTACT

+33139274581; elise.lunelli@ght-yvelinesnord.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research nurse

Model Details: Single-center, randomized, controlled, open-label interventional study on two parallel groups

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 23, 2024
• Study Start: October 22, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)