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OpenTrials
Enrolling by Invitation

NCT Number: NCT06317233

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

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.

Enrolling by Invitation

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Key information

Conditions

Chronic Pelvic Pain Syndrome Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient Satisfaction

    Time frame: at several intervals over the course of 1 year

    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.

Secondary outcomes

  1. Pain Catastrophizing

    Time frame: at several intervals over the course of 1 year

    Measured using the Pain Catastrophizing Scale which includes 13 questions scored from 0-4, with a minimum score of 0 and maximum score of 52. A higher score reflects a greater degree of pain catastrophizing.

  2. Pelvic Pain

    Time frame: at several intervals over the course of 1 year

    Measured using a validated pelvic pain specific questions, with responses ranging from 0-10, for a minimum score of 0 and maximum score of 50. A higher score reflects a greater degree of pelvic pain.

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

Outcomes of a Longitudinal Multidisciplinary Program for the Treatment of Chronic Pelvic Pain, Incorporating Online and Mobile Applications to Promote Self Efficacy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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