Endometriosis, Pelvic Pain
Conditions
Keywords
Group care, Integrative care, Pelvic floor physical therapy, Yoga, Mindfulness, Patient-centered outcomes
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.
Interventions
OTHERPeer 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
Sponsors
Washington University School of Medicine
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Interference SF 8a | 8 weeks | Change in pain interference at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Physical Function SF10a | 8 weeks | Change in physical function at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more/better physical function). |
| Female Sexual Function Index | 8 weeks | Change in reported sexual function, measured by the Female Sexual Function Index. 19-question validated survey administered to participants who endorsed being sexually active. Composite score is reported. The Scale Score Range is from 2.0 to 36.0 with higher score indicating better sexual function. |
| Endometriosis Health Profile-30 | 8 weeks | Change in endometriosis-specific quality of life (measured by Endometriosis Health Profile-30) at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. This is a 30-question survey with 5 sub-domains. Composite score is reported. The score range is from 0 (best possible health status) to 100 (worst possible health status measured by the questionnaire). Lower scores mean better health. |
| PROMIS Anxiety SF7a | 8 weeks | Change in anxiety at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more anxiety). |
| PROMIS Depression SF8b | 8 weeks | Change in depression at completion of the intervention (8-weeks) as compared to baseline is reported. Analysis was conducted using mixed-effects modeling. PROMIS measures are reported with T-scores using a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher score indicates more of the measure (i.e. more depression). Lower score indicates symptom improvement. |
| Patient Global Impression of Change (PGIC) | 8 weeks | Percentage of Participants Reporting Improved Symptoms at PEEPS completetion measured by the Patient Global Impression of Change Scale. A score of 6 or greater indicates clinically significant improvement in symptoms. |
| Modified Every Day Discrimination Scale | Baseline | To assess experiences of healthcare discrimination, this Modified Every Day Discrimination Scale was administered at baseline. It is a validated survey that assesses experience of discrimination in 10 potential domains. Percentage of participants reporting experiencing discrimination "at least a few times per year" or more frequently is reported. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age, Continuous | 33.5 year STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
None listed