beta
Trial Radar AI
Clinical Trial NCT06655584 (ENDOREV) for Suspected Endometriosis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

ENDOREV: A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis? 46 Digital Therapeutic Virtual

Recruiting
Clinical Trial NCT06655584 (ENDOREV) is an interventional study for Suspected Endometriosis that is recruiting. It started on 22 October 2024 with plans to enroll 46 participants. Led by Poissy-Saint Germain Hospital, it is expected to complete by 1 November 2026. The latest data from ClinicalTrials.gov was last updated on 23 October 2024.
Brief 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 ...

Show More
Detailed Description
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...

Show More
Official Title

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

Conditions
Suspected Endometriosis
Other Study IDs
  • ENDOREV
  • 2024-A01166-41
NCT ID Number
NCT06655584
Start Date (Actual)
2024-10-22
Last Update Posted
2024-10-23
Completion Date (Estimated)
2026-11
Enrollment (Estimated)
46
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
endometriosis
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGroup 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
Virtual 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
No Interventiongroup 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)
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of participants showing a reduction in post-consultation anxiety
Pre-consultation until post-consultation
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes

  • • 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

  • • 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
Poissy-Saint Germain Hospital logoPoissy-Saint Germain Hospital
French Interregional Group of Clinical Research and Innovation logoFrench Interregional Group of Clinical Research and Innovation
Study Responsible Party
Elise LUNELLI, Principal Investigator, research nurse, Poissy-Saint Germain Hospital
Study Central Contact
Contact: Elise LUNELLI, +33139274581, [email protected]
1 Study Locations in 1 Countries
Poissy-Saint Germain Hospital, Poissy, 78300, France
Elise LUNELLI, Contact, +33139274581, [email protected]
LUNELLI, Principal Investigator
Recruiting