Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain

Not Applicable

Completed

• Conditions: Endometriosis; Chronic Pelvic Pain

• Registration Number: NCT06352840
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-08
• Study Start: 2024-06-20
• Primary Completion: 2025-01-23
• Study Completion: 2025-04-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups	3 months	There are four questions that participants will answer from not at all (1) - very much (5). Scores range from 4-20, with higher scores meaning more interference.
PROMIS pain intensity 1a between groups	3 months	There is one question that participants will answer no pain (0) - worst pain (10). Lower score means less pain.
PROMIS Self Efficacy for Managing Symptoms SF 4a between groups	3 months	There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). Scores range from 4-20, with higher scores meaning more confident.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups	6 months	There are four questions that participants will answer from not at all (1) - very much (5). Scores range from 4-20, with higher scores meaning more interference.
PROMIS pain intensity 1a between groups	6 months	There is one question that participants will answer no pain (0) - worst pain (10). Lower score means less pain.
PROMIS Self Efficacy for Managing Symptoms SF 4a between groups	6 months	There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). Scores range from 4-20, with higher scores meaning more confident.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States