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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• • 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

Locations
Other Locations
France
Poissy-Saint Germain Hospital
RECRUITING
Poissy
Contact Information
Primary
Elise LUNELLI
elise.lunelli@ght-yvelinesnord.fr
+33139274581
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2026-11
Participants
Target number of participants: 46
Treatments
Experimental: 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
No_intervention: 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)
Related Therapeutic Areas
Sponsors
Collaborators: French Interregional Group of Clinical Research and Innovation
Leads: Poissy-Saint Germain Hospital

This content was sourced from clinicaltrials.gov