A Novel Approach to Endometriosis Treatment: Piloting an Interdisciplinary Group Care Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- PROMIS Pain Interference SF 8a
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Endometriosis group care
Groups of 6-10 patients with endometriosis and chronic pelvic pain will attend eight weekly two-hour sessions.
干预措施: Peer Empowered Endometriosis Pain Support (PEEPS) (Other)
结局指标
主要结局
PROMIS Pain Interference SF 8a
时间窗: 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).
次要结局
- Female Sexual Function Index(8 weeks)
- PROMIS Physical Function SF10a(8 weeks)
- Endometriosis Health Profile-30(8 weeks)
- PROMIS Anxiety SF7a(8 weeks)
- PROMIS Depression SF8b(8 weeks)
- Patient Global Impression of Change (PGIC)(8 weeks)
- Modified Every Day Discrimination Scale(Baseline)