Comparing Integrative Interventions for Chronic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Total score on the Female Sexual Function Index (FSFI)
研究概览
简要总结
The researchers will conduct a pilot randomized trial to assess functional changes with two different remote integrative non-pharmacologic interventions for women with chronic pelvic pain (CPP). The study team will compare a novel web-based, cognitive-behavioral program designed for patients with CPP and a commercially available physical activity remote application. The team aims to gather information about differences in sexual function, physical function, pain, and quality of life.
详细描述
My Pelvic Plan was determined as a medical device under FDA enforcement discretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Patients will be blinded to their group assignment. Study team members involved in outcome assessment will be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for a new patient visit with the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain.
- •Have chronic pelvic pain, defined as moderate to severe pelvic pain that is ≥ 4 on a 0-10 numeric rating scale (worst pain during the day) for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
- •Report moderate to severe sexual dysfunction or sexual restriction on CPP clinic intake questionnaire. This will be defined as the patient indicating one of the following responses to a question that asks them to describe their experience relative to sexual activity: my sex life is nearly normal but is very painful, my sex life is severely restricted by pain, my sex life is nearly absent because of pain, pain prevents any self life at all.
- •Have access to internet via computer and must have a smartphone
- •Willing to download and use the Bend application on their smartphone if they are randomized to that intervention
- •English-language proficiency (current version of the My Pelvic Plan website is in English)
排除标准
- •Pregnancy (at time of screening visit). Participants will be allowed to continue to study if they become pregnant during the study period.
- •Severe physical impairment precluding participating in internet-based program or remote application (for example, complete blindness or deafness)
- •Medical condition that precludes low-intensity, short-duration physical activity and gentle stretching, including cerebral palsy, severe hip or knee osteoarthritis, severe heart failure, severe Chronic obstructive pulmonary disease (COPD) requiring oxygen use
- •Prior care within the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain (seen previously but meets criteria for new patient visit because > 3 year interval since last clinic visit).
研究组 & 干预措施
Group 1- My Pelvic Plan
Patients will be randomized to receive one of two non-pharmacologic interventions. Group 1 will receive access to a novel web-based, cognitive behavioral program.
干预措施: My Pelvic Plan (Device)
Group 2- Bend
Patients will be randomized to receive one of two non-pharmacologic interventions. Group 2 will receive a subscription to a commercially available remote application.
干预措施: Bend (Behavioral)
结局指标
主要结局
Total score on the Female Sexual Function Index (FSFI)
时间窗: 8 weeks
This female sexual function index (FSFI) questionnaire calculator evaluates and monitors woman sexual functioning as well as the level of dysfunction. The FSFI ranges in scores from 2-36 where higher scores indicate more disfunction. (0's may indicate no sexual activity in period in question.)
PROMIS-29 Profile v2.1 physical function domain score
时间窗: 8 weeks
PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including physical function. Higher scores indicate more severity/worse health.
PROMIS-29 Profile v2.1 pain interference domain score
时间窗: 8 weeks
PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including pain interference. Higher scores indicate more severity/worse health.
次要结局
- Total score on the Female Sexual Function Index (FSFI)(4 weeks)
- PROMIS-29 Profile v2.1 pain interference domain score(4 weeks)
- PROMIS-29 Profile v2.1 physical function domain score(4 weeks)
研究者
Sara Till, MD, MPH
Assistant Professor of Obstetrics and Gynecology
University of Michigan