Taking people in FranceNo phase

Tests virtual reality headset to ease anxiety during gynecology visits

Tests a virtual reality headset to reduce anxiety in women with suspected endometriosis.

Key facts

Who runs it: Poissy-Saint Germain Hospital
Where: Poissy, FranceSee the site
Trial code: NCT06655584
Registry title: ENDOREV: A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis?
Status: Recruiting
People taking part: 46 people, planned
Started: 22 Oct 2024
Expected to end: Nov 2026
Type of study: Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested: Virtual reality headset Bliss DTX
Record updated: 23 October 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 to 45 referred for suspected endometriosis who are coming to the hospital for the first time. It tests whether a virtual reality headset lowers anxiety during the consultation.

Age: 18 to 45 years
Sex: Women only
Disease stage: Suspected endometriosis, with first-line or second-line imaging (ultrasound or MRI) documenting endometriosis
Earlier treatment: Must not have had major pelvic surgery for endometriosis

Main reasons for not taking part

Major pelvic surgery for endometriosis in the past
Hysterectomy
Pregnancy
Psychiatric illness or proven epilepsy
Visual or hearing impairment

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

• 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

Who cannot take part

• 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 45 years old?

Where in France

Poissy-Saint Germain HospitalPoissy, FranceContact: Elise LUNELLITaking people

About the trial

What the trial wants to find out

The aim of the research is to evaluate the effectiveness of virtual reality on the anxiety of patients with suspected endometriosis in gynecological consultation.

Read full original descriptionShow less

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.

The 2 groups in the trial

Group ATreatment being tested
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
Treatment: Virtual reality headset Bliss DTX
group BNo study treatment, for comparison
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)