Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
研究概览
简要总结
The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).
The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.
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, Outcomes Assessor)
盲法说明
Both participants and outcome assessors will be blinded to study group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants have chronic pelvic pain, defined by the protocol for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
- •Must be currently receiving care within Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain
- •Access to internet via computer or smartphone
- •English-language proficiency (current version of the website is in English)
排除标准
- •Underwent gynecologic surgery within 3 months of screening visit
- •Plan to undergo gynecologic surgery within 6 months following screening visit
- •Pregnant (self-reported) at time of screening visit. Will not exclude patients that become pregnant during the course of the study.
- •Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
- •Current psychiatric disorder with history of psychosis (for example, schizophrenia, schizoaffective disorder, delusional disorder),
- •Current suicidal ideation or suicide attempt within 2 years of screening visit. The study will screen for severe depression and suicidality at each questionnaire time point and have developed a robust triage and referral plan.
研究组 & 干预措施
Monitoring progress plus usual care
Participants will have access to the monitoring progress web-based symptom monitoring program.
干预措施: Control Group website (Behavioral)
My Pelvic Plan plus usual care
Participants will have access to My Pelvic Plan program.
干预措施: My Pelvic Plan Website (Behavioral)
结局指标
主要结局
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
时间窗: 3 months
There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.
PROMIS Pain Intensity 1a Between Groups
时间窗: 3 months
There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity.
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
时间窗: 3 months
There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence.
次要结局
- Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups(6 months)
- PROMIS Pain Intensity 1a Between Groups(6 months)
- PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups(6 months)
研究者
Sara Till, MD, MPH
Assistant Professor of Obstetrics and Gynecology
University of Michigan