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Group Care Program for Endometriosis (PEEPS Trial)
N/A
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-48 years
Operative confirmation of endometriosis
Must not have
History of hip or spine surgery
Vulvadynia or vaginismus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a program to help people with endometriosis-related pelvic pain reduce their pain and improve their quality of life. It includes peer support, education, mindfulness, and yoga.
Who is the study for?
This trial is for individuals aged 18-48 with confirmed endometriosis and chronic pelvic pain, who can attend eight weekly sessions at Washington University. It's not suitable for those planning surgery within 12 weeks, non-English speakers, pregnant women, people with severe physical impairments or a history of hip/spine surgery, frequent opioid users (except post-surgery), or those with psychiatric disorders involving psychosis.
What is being tested?
The study tests the Peer Empowered Endometriosis Pain Support (PEEPS) program to see if it reduces pain interference and improves life quality in endometriosis patients. PEEPS includes peer support, education from specialists, mindfulness practices, and yoga over eight weekly sessions.
What are the potential side effects?
Since PEEPS involves non-medical interventions like education and yoga rather than drugs or surgeries, significant side effects are not expected. However, participants may experience discomfort related to new exercises or emotional distress during discussions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 48 years old.
Select...
My endometriosis was confirmed through surgery.
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I have had pelvic pain for 6 months or more.
Select...
I do not have any surgeries planned for the next 12 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery on my hip or spine.
Select...
I have pain in my vulva or difficulty with vaginal penetration.
Select...
I have a severe physical disability.
Select...
I do not speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Interference
Secondary study objectives
Anxiety
Depression
Endometriosis-specific quality of life
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Endometriosis group careExperimental Treatment1 Intervention
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,820 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,719 Total Patients Enrolled
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