COMPLETED

Comparing Integrative Interventions for Chronic Pelvic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The researchers will conduct a pilot randomized trial to assess functional changes with two different remote integrative non-pharmacologic interventions for women with chronic pelvic pain (CPP). The study team will compare a novel web-based, cognitive-behavioral program designed for patients with CPP and a commercially available physical activity remote application. The team aims to gather information about differences in sexual function, physical function, pain, and quality of life.

Official Title

Comparing Integrative Interventions for Chronic Pelvic Pain

Quick Facts

Study Start:2025-08-12

Study Completion:2026-01-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT07066345

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Have chronic pelvic pain, defined as moderate to severe pelvic pain that is ≥ 4 on a 0-10 numeric rating scale (worst pain during the day) for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month. * Report moderate to severe sexual dysfunction or sexual restriction on CPP clinic intake questionnaire. This will be defined as the patient indicating one of the following responses to a question that asks them to describe their experience relative to sexual activity: my sex life is nearly normal but is very painful, my sex life is severely restricted by pain, my sex life is nearly absent because of pain, pain prevents any self life at all. * Have access to internet via computer and must have a smartphone * Willing to download and use the Bend application on their smartphone if they are randomized to that intervention * English-language proficiency (current version of the My Pelvic Plan website is in English)	* Pregnancy (at time of screening visit). Participants will be allowed to continue to study if they become pregnant during the study period. * Severe physical impairment precluding participating in internet-based program or remote application (for example, complete blindness or deafness) * Medical condition that precludes low-intensity, short-duration physical activity and gentle stretching, including cerebral palsy, severe hip or knee osteoarthritis, severe heart failure, severe Chronic obstructive pulmonary disease (COPD) requiring oxygen use * 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).

Inclusion Criteria

Exclusion Criteria

* 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.
* Have chronic pelvic pain, defined as moderate to severe pelvic pain that is ≥ 4 on a 0-10 numeric rating scale (worst pain during the day) for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
* Report moderate to severe sexual dysfunction or sexual restriction on CPP clinic intake questionnaire. This will be defined as the patient indicating one of the following responses to a question that asks them to describe their experience relative to sexual activity: my sex life is nearly normal but is very painful, my sex life is severely restricted by pain, my sex life is nearly absent because of pain, pain prevents any self life at all.
* Have access to internet via computer and must have a smartphone
* Willing to download and use the Bend application on their smartphone if they are randomized to that intervention
* English-language proficiency (current version of the My Pelvic Plan website is in English)

* Pregnancy (at time of screening visit). Participants will be allowed to continue to study if they become pregnant during the study period.
* Severe physical impairment precluding participating in internet-based program or remote application (for example, complete blindness or deafness)
* Medical condition that precludes low-intensity, short-duration physical activity and gentle stretching, including cerebral palsy, severe hip or knee osteoarthritis, severe heart failure, severe Chronic obstructive pulmonary disease (COPD) requiring oxygen use
* 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).

Contacts and Locations

Principal Investigator

Sara Till, MD MPH

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: Sara Till, MD, MPH

Sara Till, MD MPH, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-12

Study Completion Date2026-01-19

Study Record Updates

Study Start Date2025-08-12

Study Completion Date2026-01-19

Terms related to this study

Keywords Provided by Researchers

Chronic pelvic pain

Additional Relevant MeSH Terms

Pelvic Pain