Outcomes of a Multidisciplinary Program for the Treatment of Chronic Pelvic Pain

NCT ID: NCT06317233

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-06

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to test the impact of a detailed treatment handbook and follow-up schedule on women seeking care for chronic pelvic pain in a gynecology office-based practice. The main questions it aims to answer are:

* How does the handbook and follow-up impact patient satisfaction?
* How does the handbook and follow-up impact patient pain and quality of life scores? Participants will be randomized to receive the office standard of care, or standard of care plus a printed handbook customized to highlight their diagnosis, treatment plan and follow-up schedule.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chronic pelvic pain (CPP) is a common and multi-factorial condition resulting in high physical, emotional and psychological burden for patients. Multimodal treatments have been shown to be most effective in addressing the multifactorial nature of CPP, but remain challenging for patients and providers to navigate. Investigators have created a CPP treatment guide which clearly defines resources and management strategies in an effort to help patients understand their own diagnosis, treatment options and follow up schedule. The treatment guide includes mobile and web-based resources and applications specifically chosen to empower patients with information and to promote self-efficacy. The treatment guide is designed to be easily understood, visually appealing, and largely translatable from institution to institution. Patients using the treatment guide will be followed with a clearly defined follow up schedule, which includes touch points between appointments to aid with resource navigation. The investigators hypothesize that patients with CPP who are provided our treatment guide will experience improved satisfaction with their care, in addition to improved quality of life measures and pain scores as compared to those who undergo standard treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pelvic Pain Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment Guide plus Standard of Care

Group Type EXPERIMENTAL

Chronic Pelvic Pain Treatment Guide

Intervention Type BEHAVIORAL

The treatment guide includes mobile and web-based resources and applications specifically chosen to empower patients with information and to promote self-efficacy. The treatment guide is designed to be easily understood, visually appealing, and largely translatable from institution to institution. Patients using the treatment guide will be followed with a clearly defined follow up schedule, which includes touch points between appointments to aid with resource navigation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chronic Pelvic Pain Treatment Guide

The treatment guide includes mobile and web-based resources and applications specifically chosen to empower patients with information and to promote self-efficacy. The treatment guide is designed to be easily understood, visually appealing, and largely translatable from institution to institution. Patients using the treatment guide will be followed with a clearly defined follow up schedule, which includes touch points between appointments to aid with resource navigation.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women age 18 or older
* Diagnosis of chronic pelvic pain

Exclusion Criteria

* Primary language other than English
* Pregnancy
* Inability to attend follow-up appointment
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00007131

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mindful Movement for Pelvic Pain
NCT05899088 UNKNOWN NA
Endometriosis Pain
NCT06101303 RECRUITING
Global Study of Women's Health
NCT00849173 COMPLETED
Pelvic Pain Electro-Acupuncture
NCT07305025 NOT_YET_RECRUITING NA