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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HD099283-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| My Pelvic Plan | Experimental | This is a web-based self-guided program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Pelvic Plan website | Behavioral | Following the baseline interview, participants will receive a link to a web-based self-guided program and have access for two weeks "My Pelvic Plan" that combines education on several individual conditions that often contribute to CPP, and will include instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Subsequent to this, participants will then complete another brief questionnaire after a two-week interval. This questionnaire will focus on willingness to consider specific treatment modalities, credibility/expectancy for specific treatment modalities, and a brief measure assessing self-efficacy for managing symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Explore factors that influence patient perceptions of treatment modalities for chronic pelvic pain | Explore prior treatment experiences, attitudes/perceptions of treatment modalities, sources of medical information. Baseline questionnaire and individual structured interview will be used. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported interest in treatment modalities | To evaluate whether brief exposure to a novel web-based educational and self-management program for chronic pelvic pain increases willingness to consider various treatment modalities one question will be asked. The question states are participants interested in trying six different treatment modalities and select from "yes, definitely interested", "would consider", "not sure, need to hear more about this option", or "not interested". |
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Inclusion Criteria:
Exclusion Criteria:
female sex assigned at birth, may include cis-gender, trans-gender, nonbinary
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| Name | Affiliation | Role |
|---|---|---|
| Sara Till, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 8, 2024 | Oct 23, 2025 | ICF_000.pdf |
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| Baseline, 3 weeks (post baseline) |
| Change in credibility/expectancy questionnaire (CEQ) | The CEQ is a self-report measure assessing the credibility and expectancy of treatment received. It consists of 6 items, 4 items with a 9-point Likert-type rating of 1 (not at all) to 5 (very much) with a scoring range of 3-27. The other 2 items are on a percentage scale from 0%-100% in increments of 10 with a scoring range of means 0-100%. Higher scores denote higher treatment credibility and expectancy. | Baseline, 3 weeks (post baseline) |