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

Title :

ENDOREV: A solution to reduce anxiety during gynecological consultations in patients with suspected endometriosis?

Description of the study :

Single-center, randomized, controlled, open-label interventional study on two parallel groups Study composed of 46 patients randomized into two groups A and B with a ratio of 1:1 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 Group B control: The patient will be seated and wait for the doctor to arrive (no material) The duration of inclusion is 18 months and individual participation is 6 months, that is to say 24 months for the entire study.

Completion of the questionnaire (IASTA Y-1) for both groups before the consultation and data collection.

Filling of the CRF in consultation by the doctor Completion of the questionnaire (IASTA Y-1) for both arms after the consultation and data collection Telephone call at 6 months with data collection on compliance with endometriosis monitoring

Objectives :

Primary objectives :

• Evaluate the effectiveness of virtual reality on anxiety in women with suspected endometriosis during the gynecological consultation.

Secondary objectives :

• Study the effect of virtual reality on compliance with endometriosis monitoring following the gynecological consultation
• Evaluate the effect of virtual reality on the pain felt during the gynecological examination
• Evaluate the level of satisfaction with the device during the session

Hypothesis :

• Null hypothesis (H0): No significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores
• Alternative hypothesis (H1): There is a significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores.

Inclusion criteria

• 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

Exclusion criteria

• 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

Place of the study :

Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye

Contact details :

Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye Address: 10 rue du Champ Gaillard, 78300 Poissy Tel: +33139274581 Email: [email protected]

Speakers :

• Promoter: Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye
• Coordinating investigator: Ms. Elise LUNELLI (registered nurse)

Funding :

GIRCI IDF and ARS IDF funding as part of the call for projects " Appel à projets recherche en soins (APRESO) "2024

Calendar :

Primary submission : 11/09/24 Secondary submission :26/09/24

Inclusion criteria

• • 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

Exclusion criteria

• • 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