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Completed

NCT Number: NCT06352840

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

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.

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Key information

Conditions

Chronic Pelvic Pain Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

My Pelvic Plan Website

Behavioral

This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.

Control Group website

Behavioral

Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).

Primary outcomes

  1. Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups

    Time frame: 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.

  2. PROMIS Pain Intensity 1a Between Groups

    Time frame: 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.

  3. PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups

    Time frame: 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.

Secondary outcomes

  1. Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups

    Time frame: 6 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.

  2. PROMIS Pain Intensity 1a Between Groups

    Time frame: 6 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.

  3. PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups

    Time frame: 6 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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