Background The management of chronic pelvic pain in women with endometriosis is complex and includes the long-term use of opioids. Patients not fully responsive to drugs or ineligible for surgical treatments need efficient alternatives to improve their quality of life and avoid long-term sequelae. Objective This randomized controlled trial aimed to assess the effects of repeated at-home administrations of a 20-minute virtual reality (VR) solution (Endocare) compared with a sham condition on pain in women experiencing pelvic pain due to endometriosis. Methods Patients were instructed to use the VR headsets twice daily for at least 2 days and for up to 5 days starting on their first day of painful periods. Pain perception was measured using a numerical scale (0-10) before and 60, 120, and 180 minutes after each treatment administration. General pain, stress, fatigue, medication intake, and quality of life were reported daily by patients. Results A total of 102 patients with endometriosis were included in the final analysis (Endocare group: n=51, 50%; sham group: n=51, 50%). The mean age was 32.88 years (SD 6.96) and the mean pain intensity before treatment was 6.53 (SD 1.74) and 6.22 (SD 1.69) for the Endocare group and the sham control group, respectively (P=.48). Pain intensity decreased in both groups from day 1 to day 5 along with a decrease in medication use. Maximum pain intensity reduction of 51.58% (SD 35.33) occurred at day 2, 120 minutes after treatment for the Endocare group and of 27.37% (SD 27.23) at day 3, 180 minutes after treatment for the control group. Endocare was significantly superior to the sham on day 1 (120 minutes, P=.04; 180 minutes, P=.001), day 2 (0 minutes, P=.02; 60, 120, and 180 minutes, all P<.001), and day 3 (60 minutes, P=.01; 120 minutes, P=.005; 180 minutes, P=.001). Similarly, the mean perceived pain relief was significantly higher with Endocare on day 1 (120 and 180 minutes P=.004 and P=.001, respectively) and day 2 (60, 120, and 180 minutes P=.003, P=.004, and P=.007, respectively) compared to the control. No adverse event was reported. Conclusions This study confirmed the effectiveness and safety of self-repeated administrations of a VR immersive treatment used at home while reducing overall pain medication intake in women diagnosed with endometriosis experiencing moderate-to-severe pelvic pain. Trial Registration ClinicalTrials.gov NCT05172492; https://clinicaltrials.gov/ct2/show/NCT05172492

BACKGROUND The management of chronic pelvic pain in women with endometriosis is complex and includes long-term use of opioids. Patients not fully responsive to drugs, or ineligible for surgical treatments need efficient alternatives to improve their quality of life and avoid long-term sequelae. OBJECTIVE This randomized controlled trial, software under test (Endocare) vs. sham, aimed to assess the effects of repeated at home administrations of a 20-minutes virtual reality (VR) solution on pain in women experiencing pelvic pain due to endometriosis. METHODS Patients were instructed to use VR headsets twice daily during at least 2 days and up to 5 days starting on their first day of painful periods. Pain perception was measured using a numerical scale (0 – 10) before and 60, 120, 180 minutes after each treatment administration. General pain, stress, fatigue, medication intake and quality of life were daily reported by patients. RESULTS 102 patients were included in the final analysis (mean age 32.88 years (SD 6.96)). The mean pain intensity before treatment was 6.53 (SD 1.74) and 6.22 (SD 1.69) for the Endocare group and the control group. Pain intensity decreased in both groups from day 1 to day 5 as well as medication use. Maximum pain intensity reduction was 51.58% (SD 35.33) at D2.T120 and 27.37% (SD 27.23) at D3.T180 for the Endocare group and the control group respectively. The Endocare was significantly superior to the sham on day 1 (T120, T180), day 2 and day 3 (T60, T120, T180). Similarly, the mean perceived pain relief was significantly higher with Endocare on day 1 (T120, T180) and day 2 (T60, T120, T180) compared to the control. No adverse event was reported. CONCLUSIONS This study confirmed the effectiveness and safety of self-repeated administrations of a virtual reality immersive treatment used at home while reducing overall pain medication intake in women diagnosed with endometriosis experiencing moderate-to-severe pelvic pain and supports. CLINICALTRIAL ClinicalTrials.gov: NCT05172492