RecruitingNot ApplicableNCT06655584

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


Sponsor

Poissy-Saint Germain Hospital

Enrollment

46 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether virtual reality (VR) — immersive headset experiences — can reduce anxiety during gynecological consultations in women attending their first appointment for suspected endometriosis (a condition where tissue similar to the uterine lining grows outside the uterus). **You may be eligible if...** - You are between 18 and 45 years old - You are attending a hospital gynecology clinic for the first time with suspected endometriosis - You have already had an ultrasound or MRI showing findings consistent with endometriosis - You are covered by a social security scheme (France-based study) **You may NOT be eligible if...** - You have previously been seen at this hospital for endometriosis - You do not have imaging evidence of endometriosis - You are outside the 18–45 age range - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtual 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


Locations(1)

Poissy-Saint Germain Hospital

Poissy, France

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NCT06655584