Clinical trial NCT06540560: Exploring Patient Treatment Preferences for Chronic Pelvic Pain: A Mixed Methods Study
Official title: Exploring Patient Treatment Preferences for Chronic Pelvic Pain: A Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pelvic Pain
Keywords: Structured interview
Questionnaires
Web-based educational program
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-08-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research is studying what things change the way people think about treatment for chronic pelvic pain (CPP). The study team is also interested in whether a web-based educational and self-management program for chronic pelvic pain changes how people think about chronic pelvic pain treatments. The program contains several different self-guided modules that include cognitive and behavioral structuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques.

The study hypothesis is that patients with CPP will report that prior treatment experiences and most trusted source of medical information will be associated with baseline perceptions of various CPP treatment modalities.


Eligibility criteria: Inclusion Criteria:

* Have chronic pelvic pain, defined as moderate to severe pelvic pain (based on protocol) for greater or equal to(≥) 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
* Must be 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.
* Access to internet via computer or smartphone
* English-language proficiency (current version of the website is in English)
* The study team will attempt to recruit a diverse group of patients, with attention to diversity in race, ethnicity, education level, rural vs urban locality, sexual orientation, and gender identification.

Exclusion Criteria:

* Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
* 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).

Primary outcomes:
measure: Explore factors that influence patient perceptions of treatment modalities for chronic pelvic pain
timeFrame: Baseline
Secondary outcomes:
measure: Change in self-reported interest in treatment modalities
timeFrame: Baseline, 3 weeks (post baseline)
measure: Change in credibility/expectancy questionnaire (CEQ)
timeFrame: Baseline, 3 weeks (post baseline)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sara Till, MD
role: PRINCIPAL_INVESTIGATOR
References: