Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial
BackgroundThe 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 avoi...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2023-06-01
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| Series: | Journal of Medical Internet Research |
| Online Access: | https://www.jmir.org/2023/1/e47869 |
| _version_ | 1797733992092401664 |
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| author | Benjamin Merlot Valéry Elie Adrien Périgord Zoé Husson Amandine Jubert Isabella Chanavaz-Lacheray Thomas Dennis Maryne Cotty-Eslous Horace Roman |
| author_facet | Benjamin Merlot Valéry Elie Adrien Périgord Zoé Husson Amandine Jubert Isabella Chanavaz-Lacheray Thomas Dennis Maryne Cotty-Eslous Horace Roman |
| author_sort | Benjamin Merlot |
| collection | DOAJ |
| description |
BackgroundThe 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.
ObjectiveThis 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.
MethodsPatients 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.
ResultsA 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.
ConclusionsThis 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 RegistrationClinicalTrials.gov NCT05172492; https://clinicaltrials.gov/ct2/show/NCT05172492 |
| first_indexed | 2024-03-12T12:36:40Z |
| format | Article |
| id | doaj.art-d50b930ff6c14deda4c2ae69882b9e29 |
| institution | Directory Open Access Journal |
| issn | 1438-8871 |
| language | English |
| last_indexed | 2024-03-12T12:36:40Z |
| publishDate | 2023-06-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | Journal of Medical Internet Research |
| spelling | doaj.art-d50b930ff6c14deda4c2ae69882b9e292023-08-29T00:08:11ZengJMIR PublicationsJournal of Medical Internet Research1438-88712023-06-0125e4786910.2196/47869Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled TrialBenjamin Merlothttps://orcid.org/0000-0002-1779-3196Valéry Eliehttps://orcid.org/0000-0002-8500-8516Adrien Périgordhttps://orcid.org/0009-0004-5653-7701Zoé Hussonhttps://orcid.org/0000-0003-2937-0649Amandine Juberthttps://orcid.org/0000-0002-3404-7742Isabella Chanavaz-Lacherayhttps://orcid.org/0000-0002-8624-0309Thomas Dennishttps://orcid.org/0000-0003-1883-2326Maryne Cotty-Esloushttps://orcid.org/0000-0001-8551-5326Horace Romanhttps://orcid.org/0000-0002-9237-0628 BackgroundThe 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. ObjectiveThis 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. MethodsPatients 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. ResultsA 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. ConclusionsThis 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 RegistrationClinicalTrials.gov NCT05172492; https://clinicaltrials.gov/ct2/show/NCT05172492https://www.jmir.org/2023/1/e47869 |
| spellingShingle | Benjamin Merlot Valéry Elie Adrien Périgord Zoé Husson Amandine Jubert Isabella Chanavaz-Lacheray Thomas Dennis Maryne Cotty-Eslous Horace Roman Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial Journal of Medical Internet Research |
| title | Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial |
| title_full | Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial |
| title_fullStr | Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial |
| title_full_unstemmed | Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial |
| title_short | Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial |
| title_sort | pain reduction with an immersive digital therapeutic in women living with endometriosis related pelvic pain at home self administered randomized controlled trial |
| url | https://www.jmir.org/2023/1/e47869 |
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