NCT06540560

Brief Summary

This research is studying what things change the way people think about treatment for chronic pelvic pain (CPP). The study team is also interested in whether a web-based educational and self-management program for chronic pelvic pain changes how people think about chronic pelvic pain treatments. The program contains several different self-guided modules that include cognitive and behavioral structuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. The study hypothesis is that patients with CPP will report that prior treatment experiences and most trusted source of medical information will be associated with baseline perceptions of various CPP treatment modalities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2025

Completed
Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

4 months

First QC Date

August 2, 2024

Last Update Submit

October 23, 2025

Conditions

Keywords

Structured interviewQuestionnairesWeb-based educational program

Outcome Measures

Primary Outcomes (1)

  • Explore factors that influence patient perceptions of treatment modalities for chronic pelvic pain

    Explore prior treatment experiences, attitudes/perceptions of treatment modalities, sources of medical information. Baseline questionnaire and individual structured interview will be used.

    Baseline

Secondary Outcomes (2)

  • Change in self-reported interest in treatment modalities

    Baseline, 3 weeks (post baseline)

  • Change in credibility/expectancy questionnaire (CEQ)

    Baseline, 3 weeks (post baseline)

Study Arms (1)

My Pelvic Plan

EXPERIMENTAL

This is a web-based self-guided program.

Behavioral: My Pelvic Plan website

Interventions

Following the baseline interview, participants will receive a link to a web-based self-guided program and have access for two weeks "My Pelvic Plan" that combines education on several individual conditions that often contribute to CPP, and will include instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Subsequent to this, participants will then complete another brief questionnaire after a two-week interval. This questionnaire will focus on willingness to consider specific treatment modalities, credibility/expectancy for specific treatment modalities, and a brief measure assessing self-efficacy for managing symptoms.

My Pelvic Plan

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale sex assigned at birth, may include cis-gender, trans-gender, nonbinary
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have chronic pelvic pain, defined as moderate to severe pelvic pain (based on protocol) for greater or equal to(≥) 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
  • Must be 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.
  • Access to internet via computer or smartphone
  • English-language proficiency (current version of the website is in English)
  • The study team will attempt to recruit a diverse group of patients, with attention to diversity in race, ethnicity, education level, rural vs urban locality, sexual orientation, and gender identification.

You may not qualify if:

  • Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Sara Till, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 6, 2024

Study Start

April 28, 2025

Primary Completion

September 2, 2025

Study Completion

September 2, 2025

Last Updated

October 27, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations