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

NCT06655584 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-10-23

No results posted yet for this study

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.

Conditions

  • Suspected Endometriosis

Interventions

DEVICE

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

Sponsors & Collaborators

  • French Interregional Group of Clinical Research and Innovation

    collaborator OTHER

  • Poissy-Saint Germain Hospital

    lead OTHER

Principal Investigators

  • Arnaud FAUCONNIER, PROFESSOR · Pr FAUCONNIER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2026-05-31
Completion
2026-11-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06655584 on ClinicalTrials.gov