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

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.

Conditions

• Chronic Pelvic Pain
• Endometriosis

Interventions

BEHAVIORAL

My Pelvic Plan Website

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.

BEHAVIORAL

Control Group website

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).

Sponsors & Collaborators

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

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Sara Till, MD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-20

Primary Completion

2025-01-23

Completion

2025-04-28

Countries

• United States

Study Locations