Endometriosis Group Care
- Conditions
- EndometriosisPelvic Pain
- Interventions
- Other: Peer Empowered Endometriosis Pain Support (PEEPS)
- Registration Number
- NCT05622955
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 33
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endometriosis group care Peer Empowered Endometriosis Pain Support (PEEPS) Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
- Primary Outcome Measures
Name Time Method Pain Interference 8 weeks Change in reported pain after PEEPS program completion by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
- Secondary Outcome Measures
Name Time Method Physical Function 8 weeks Change in reported physical function, measured by the PROMIS Physical Function Scale
Endometriosis-specific quality of life 8 weeks Endometriosis-specific quality of life, measured by Endometriosis Health Profile-30
Depression 8 weeks Change in reported depression, measured by the PROMIS Depression Scale
Sexual Function 8 weeks Change in reported sexual function, measured by the Female Sexual Function Index
Anxiety 8 weeks Change in reported anxiety, measured by the PROMIS Anxiety Scale
Overall symptom improvement 8 weeks Change in overall symptoms, measured by the Patient Global Impression of Change Scale
Modified every day discrimination scale Baseline To assess experiences of healthcare discrimination
Pain Catastrophizing 8 weeks Change in reported catastrophizing, measured by the Pain Catastrophizing Scale
Trial Locations
- Locations (1)
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States