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

NCT06317233 | Enrolling By Invitation

• 1 other identifier: STUDY00007131
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pelvic Pain Syndrome

Keywords

treatment guide; patient satisfaction; pain scores

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18). The PSQ-18 yields separate scores for each of seven different subscales: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience. The items are scored so that high scores reflect satisfaction with medical care on a 1-5 scale.

  at several intervals over the course of 1 year

Secondary Outcomes (2)

• Pain Catastrophizing

  at several intervals over the course of 1 year

• Pelvic Pain

  at several intervals over the course of 1 year

Study Arms (2)

Standard of Care

NO INTERVENTION

Treatment Guide plus Standard of Care

EXPERIMENTAL

Behavioral: Chronic Pelvic Pain Treatment Guide

Interventions

Chronic Pelvic Pain Treatment Guide 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.

Treatment Guide plus Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Primary language other than English
• Pregnancy
• Inability to attend follow-up appointment

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 19, 2024
• Study Start: July 6, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)