Study Results
Results pending
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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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
33 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-02-20
Study Completion Date
2025-07-31
Brief Summary
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The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with endometriosis-related pelvic pain. The main question\[s\] it aims to answer are:
* Is PEEPS effective at decreasing pain interference and improving patient-reported quality of life outcomes?
* What are the barriers and facilitators to PEEPS implementation? Participants will engage in eight weekly 2-hour sessions led by an endometriosis specialist, pain psychologist, pelvic floor physical therapist, and yoga instructor. At these sessions they will participate in peer support, education, mindfulness, and yoga.
* Is PEEPS effective at decreasing pain interference and improving patient-reported quality of life outcomes?
* What are the barriers and facilitators to PEEPS implementation? Participants will engage in eight weekly 2-hour sessions led by an endometriosis specialist, pain psychologist, pelvic floor physical therapist, and yoga instructor. At these sessions they will participate in peer support, education, mindfulness, and yoga.
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Detailed Description
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This is an 8 week interdisciplinary, integrative group care program conducted through the Department of Obstetrics and Gynecology (OB/GYN) at Washington University in St. Louis (WUSTL). The program, called PEEPS, incorporates mindfulness, physical therapy, yoga, physical activity, nutrition, and education. Additionally, PEEPS will provide peer support and demonstrate investment of individual clinicians and the healthcare system.
The program focuses on equipping participants with pain management and coping skills so they have an expanded toolkit to manage their pain after completing the program.
The program focuses on equipping participants with pain management and coping skills so they have an expanded toolkit to manage their pain after completing the program.
Conditions
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Endometriosis
Pelvic Pain
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Endometriosis group care
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
Group Type
EXPERIMENTAL
Peer Empowered Endometriosis Pain Support (PEEPS)
Intervention Type
OTHER
The sessions will provide education on endometriosis, mindfulness, yoga, nutrition, and strategies to cope with chronic pain. Patients will additionally receive peer and clinician support to decrease the social isolation experienced by people with endometriosis
Interventions
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Peer Empowered Endometriosis Pain Support (PEEPS)
The sessions will provide education on endometriosis, mindfulness, yoga, nutrition, and strategies to cope with chronic pain. Patients will additionally receive peer and clinician support to decrease the social isolation experienced by people with endometriosis
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Age 18-48 years
* Operative confirmation of endometriosis
* Chronic pelvic pain (defined as pain perceived to originate from the pelvis, lasting ≥6 months)
* No plan to have surgery in next 12 weeks
* Be able to attend eight 2-hour weekly sessions on the Washington University campus
* Operative confirmation of endometriosis
* Chronic pelvic pain (defined as pain perceived to originate from the pelvis, lasting ≥6 months)
* No plan to have surgery in next 12 weeks
* Be able to attend eight 2-hour weekly sessions on the Washington University campus
Exclusion Criteria
* Non-English speaking
* Currently pregnant
* Severe physical impairment
* History of hip or spine surgery
* Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
* Current or history of psychiatric disorder with psychosis
* Vulvadynia or vaginismus
* Currently pregnant
* Severe physical impairment
* History of hip or spine surgery
* Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
* Current or history of psychiatric disorder with psychosis
* Vulvadynia or vaginismus
Minimum Eligible Age
18 Years
Maximum Eligible Age
48 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Washington University in St. Louis
St Louis, Missouri, United States
Site Status
Countries
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United States
References
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Other Identifiers
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202206202
Identifier Type: -
Identifier Source: org_study_id
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