Actively Recruiting
ENDOREV: A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis?
Led by Poissy-Saint Germain Hospital · Updated on 2024-10-23
46
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
P
Poissy-Saint Germain Hospital
Lead Sponsor
F
French Interregional Group of Clinical Research and Innovation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ENDOREV: A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Poissy-Saint Germain Hospital
Poissy, France, 78300
Actively Recruiting
Research Team
E
Elise LUNELLI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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