Introduction
endometriosis, bleeding, chronic pelvic pain, pelvic pain, inflammation, dyspareunia, acute pain, visual and auditory therapeutic, dysmenorrhea, pain
ENDOMETRIOSIS, ENDOMETRIOSIS, BLEEDING, PROLIFERATION, INFLAMMATION, DYSPAREUNIA, DYSMENORRHEA, UTERUS
Chronic pelvic pain is the main symptom of women suffering from endometriosis [Endometriosis is characterized by the occurrence of lesions with behavior comparable to that of the endometrium, including cyclic bleeding during periods, followed by inflammation and proliferation of the conjunctive and muscular cells outside the uterus, mainly on the pelvic peritoneum, ovaries, and rectovaginal septum [The most common painful symptom of endometriosis is dysmenorrhea (80%), followed by deep dyspareunia (30%) [Medical treatments, including combined hormonal contraceptives, progestin, and gonadotropin-releasing hormone agonists, are generally effective in treating endometriosis-related pain [Surgery is usually not considered as a first-line treatment [Therefore, the management of patients with endometriosis who are not eligible, are refractory, or not fully responsive to hormonal therapies or drug treatments, or are ineligible for surgical treatment (ie, awaiting pregnancy or not recommended for surgery) remains a problem. Accordingly, nonpharmacological alternatives are urgently needed to increase the chronic pelvic pain therapeutic arsenal.Studies have shown that virtual reality (VR) is an effective mode to reduce acute pain such as that experienced by burn victims, in cases of lumbar puncture, women during labor, or dental surgery [Endocare is a class I medical device, or digital therapeutic (DTx), consisting of visual and auditory therapeutic procedures administered using a VR headset to treat pelvic-perineal pain in patients with endometriosis at home. Promising results of the use of Endocare were reported in a single-dose pilot study conducted in a controlled hospital setting in women with pelvic-perineal pain of ≥4/10 intensity: the study treatment provided pain relief and decreased pain intensity by a maximum of 42% compared with only 22% in the control group (Considering that chronic pelvic pain should be treated at home and not only in a medical environment, this study was conducted to evaluate the efficacy and safety of a VR treatment (Endocare) to reduce chronic pelvic pain when used at home in full autonomy without medical supervision compared to a digital control in a double-blinded, randomized, sham-controlled clinical trial. The objective of the study was to evaluate the effects of Endocare compared to a digital control on the mean change in pain intensity 1, 2, and 3 hours after daily use during the 5 most painful consecutive days of the month in women with chronic pelvic-perineal pain associated with endometriosis.