Actively Recruiting
Reducing Anxiety with Virtual Reality During Gynecological Consultations for Women Suspected of Endometriosis
Led by Poissy-Saint Germain Hospital · Updated on 2024-10-23
46
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of virtual reality on reducing anxiety in women with suspected endometriosis during gynecological consultations. The study recognizes that patients often feel anxious in this situation and explores digital therapy as a method to help manage this anxiety. The trial is randomized and controlled, involving 46 patients divided into two groups, and is conducted over an 18-month inclusion period with individual participation lasting 6 months. Participants in the experimental group will receive Bliss DTX digital therapy, which uses a specialized video headset and audio headset to immerse patients in calming sound and visual programs for 13 minutes before their consultation. The control group will wait in the reception room without any intervention. Both groups will complete anxiety questionnaires before and after the consultation. Six months after the consultation, a follow-up call will collect information on compliance with endometriosis monitoring. Throughout the study, patients will be assessed using anxiety questionnaires and data collected during consultations. The primary outcome is the reduction in anxiety levels from before to after the consultation. Secondary assessments include pain experienced during the gynecological exam and satisfaction with the virtual reality device. Safety monitoring notes possible side effects such as nausea or dizziness related to the virtual reality headset. The total study duration for participants is 6 months, with data collection also at the 6-month follow-up.
CONDITIONS
Brief Title
ENDOREV: A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis?
Research Team
E
Elise LUNELLI
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