Chronic Pelvic Pain Syndrome
Conditions
Keywords
treatment guide, patient satisfaction, pain scores
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.
Detailed description
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.
Interventions
BEHAVIORALChronic 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.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing | 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. |
| Pelvic Pain | 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. |
Countries
United States
Outcome results
None listed