Pain reduction with an immersive digital therapeutic in women suffering from endometriosis-related pelvic pain: a randomized, controlled, open-label, two-parallel-group, interventional study (Preprint)

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AI-generated summary by claude@2026-06, 2026-06-13

This study found that a 20-minute immersive digital therapeutic significantly reduced endometriosis-related pelvic pain for up to 4 hours compared to a 2D digital control.

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AI-generated deep summary by claude@2026-06, 2026-06-13 · read from full text

This randomized, controlled, open-label pilot study tested whether a single 20-minute session of an immersive virtual reality digital therapeutic (Endocare) reduces pain in 45 women diagnosed with endometriosis-related pelvic pain, compared with a 2D digital control. Pain and pain relief were assessed before treatment and at multiple time points up to 240 minutes (4 hours) afterward. Endocare significantly reduced post-treatment pain compared with baseline and outperformed the 2D control at several early post-treatment intervals (15–45 minutes), with effects persisting up to 4 hours, whereas the control group did not show significant pain reduction at those comparisons. The paper is limited as an open-label pilot with a small sample size. This paper is centrally about endometriosis — it evaluates a VR digital therapeutic (Endocare) for immediate and up to 4-hour pain reduction in women with endometriosis-related pelvic pain.

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Abstract

BACKGROUND Chronic pelvic pain is a frequent debilitating condition in women suffering from endometriosis. Pharmacological and surgical treatments are not always efficient in controlling pain and present important restriction. Digital Therapeutics (DTx) are emerging as major non-pharmacological alternatives, aiming to extend the analgesic therapeutic arsenal of the patients. OBJECTIVE In this randomized controlled trial (RCT), we aimed to measure the immediate and 4 hours persisting effects of a single use 20-minutes long DTx (Endocare) on pain in women suffering from pelvic pain related to endometriosis. METHODS Forty-five women suffering from endometriosis participated in a randomized controlled study comparing the analgesic effect of a single use of a virtual reality digital treatment (Endocare, n = 23) to a 2D digital control (n = 22). Perceived pain and pain relief were measured before the treatment and 15-, 30-, 45-, 60-, and 240-minutes after the end of the treatment. RESULTS The clustered post-treatment pain is significantly reduced compared to the pretreatment for both Endocare and the control group (all P<.01). Endocare was significantly more efficient than the control group (all P<.01). When comparing each post-treatment measures to the pretest, Endocare significantly reduces pain perception for all times up to 4 hours post-treatment. The differences didn’t reached significance for the control group. Moreover, Endocare was significantly superior to the control group for 15-, 30- and 45-minutes after the treatment (all P.05). CONCLUSIONS To our knowledge, our study is the first to test the effects of a single use of a DTx treatment on reported pain at different time points in patients diagnosed with endometriosis perceiving moderate-to-severe pelvic pain. Importantly, our result supports that Endocare, a VR immersive treatment, significantly reduce pain perception compared to a digital control in women suffering from endometriosis. Interestingly, we are the first to notice the effect persisted up to 4 hours post-treatment. CLINICALTRIAL ClinicalTrials.gov NCT04650516
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Abstract

Background: Chronic pelvic pain is a frequent debilitating condition in women suffering from endometriosis. Pharmacological and surgical treatments are not always efficient in controlling pain and present important restriction. Digital Therapeutics (DTx) are emerging as major non-pharmacological alternatives, aiming to extend the analgesic therapeutic arsenal of the patients.

Objective

In this randomized controlled trial (RCT), we aimed to measure the immediate and 4 hours persisting effects of a single use 20-minutes long DTx (Endocare) on pain in women suffering from pelvic pain related to endometriosis.

Methods

Forty-five women suffering from endometriosis participated in a randomized controlled study comparing the analgesic effect of a single use of a virtual reality digital treatment (Endocare, n = 23) to a 2D digital control (n = 22). Perceived pain and pain relief were measured before the treatment and 15-, 30-, 45-, 60-, and 240-minutes after the end of the treatment.

Results

The clustered post-treatment pain is significantly reduced compared to the pretreatment for both Endocare and the control group (all P<.01). Endocare was significantly more efficient than the control group (all P<.01). When comparing each post-treatment measures to the pretest, Endocare significantly reduces pain perception for all times up to 4 hours post-treatment. The differences didn’t reached significance for the control group. Moreover, Endocare was significantly superior to the control group for 15-, 30- and 45-minutes after the treatment (all P.05).

Conclusions

To our knowledge, our study is the first to test the effects of a single use of a DTx treatment on reported pain at different time points in patients diagnosed with endometriosis perceiving moderate-to-severe pelvic pain. Importantly, our result supports that Endocare, a VR immersive treatment, significantly reduce pain perception compared to a digital control in women suffering from endometriosis. Interestingly, we are the first to notice the effect persisted up to 4 hours post-treatment. Clinical Trial: ClinicalTrials.gov NCT04650516 Citation Request queued. Please wait while the file is being generated. It may take some time. Copyright © The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.

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endometriosischronic_pelvic_pain

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last seen: 2026-06-10T17:14:06.276822+00:00
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