Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home
NCT ID: NCT05172492
Last Updated: 2022-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2021-12-07
2022-09-30
Brief Summary
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Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women.
Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis.
Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected.
The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Endocare
Endocare
Endocare will be administred through a virtual reality headseat used one to twice a day.
Digital control
Digital control
Digital control will be administred through a virtual reality headseat used one to twice a day.
Interventions
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Endocare
Endocare will be administred through a virtual reality headseat used one to twice a day.
Digital control
Digital control will be administred through a virtual reality headseat used one to twice a day.
Eligibility Criteria
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Inclusion Criteria
* Women with at least 2 consecutive days per month of endometriosis-related pelvic-perineal pain of moderate to severe intensity (NS ≥ 4):
* Women without amenorrhea: pain around the onset of menstruation.
* Women with amenorrhea: most intense pain of the month.
Exclusion Criteria
* Women participating, or who have participated, in a clinical interventional study within 30 days prior to inclusion.
* Women with severe visual, auditory or cognitive impairment, color blindness, photosensitivity, epilepsy or motion sickness.
* Women whose pain is occasional and not present at each menstrual period.
* Women who have previously received virtual reality treatments.
* Women under judicial protection, guardianship, curatorship, protective mandate.
18 Years
FEMALE
No
Sponsors
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Biotrial
INDUSTRY
Lucine
INDUSTRY
Responsible Party
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Locations
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Clinique Tivoli Ducos
Bordeaux, Gironde, France
Countries
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Facility Contacts
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References
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Merlot B, Elie V, Perigord A, Husson Z, Jubert A, Chanavaz-Lacheray I, Dennis T, Cotty-Eslous M, Roman H. Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial. J Med Internet Res. 2023 Jun 28;25:e47869. doi: 10.2196/47869.
Other Identifiers
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2021-A02358-33
Identifier Type: -
Identifier Source: org_study_id
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