Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Apr 4, 2023
Open Peer Review Period: Apr 4, 2023 - Apr 19, 2023
Date Accepted: May 26, 2023
Date Submitted to PubMed: Jun 1, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Pain Reduction with an Immersive Digital Therapeutic in Women Living with Endometriosis-Related Pelvic Pain: at-home self administered randomized controlled trial
ABSTRACT
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. Clinical Trial: ClinicalTrials.gov: NCT05172492
Citation
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