The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP). The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
University of Michigan
Ann Arbor, Michigan, United States
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.
Time frame: 3 months
PROMIS Pain Intensity 1a Between Groups
There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity.
Time frame: 3 months
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence.
Time frame: 3 months
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.
Time frame: 6 months
PROMIS Pain Intensity 1a Between Groups
There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity.
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Time frame: 6 months
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence.
Time frame: 6 months