University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT07066345
The researchers will conduct a pilot randomized trial to assess functional changes with two different remote integrative non-pharmacologic interventions for women with chronic pelvic pain (CPP). The study team will compare a novel web-based, cognitive-behavioral program designed for patients with CPP and a commercially available physical activity remote application. The team aims to gather information about differences in sexual function, physical function, pain, and quality of life.
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Notify Me18 year–55 year
Female
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
My Pelvic Plan was determined as a medical device under FDA enforcement discretion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
My Pelvic Plan is comprised of a self-guided program that combines education on several individual conditions that often contribute to CPP, and will include instruction on cognitive and behavioral restructuring techniques that can help to manage chronic pelvic pain symptoms.
Bend is a highly rated physical activity application that helps guide users through gentle stretching and yoga poses.
Time frame: 8 weeks
This female sexual function index (FSFI) questionnaire calculator evaluates and monitors woman sexual functioning as well as the level of dysfunction. The FSFI ranges in scores from 2-36 where higher scores indicate more disfunction. (0's may indicate no sexual activity in period in question.)
Time frame: 8 weeks
PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including physical function. Higher scores indicate more severity/worse health.
Time frame: 8 weeks
PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including pain interference. Higher scores indicate more severity/worse health.
Time frame: 4 weeks
This female sexual function index (FSFI) questionnaire calculator evaluates and monitors woman sexual functioning as well as the level of dysfunction. The FSFI ranges in scores from 2-36 where higher scores indicate more disfunction. (0's may indicate no sexual activity in period in question.)
Time frame: 4 weeks
PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including pain interference. Higher scores indicate more severity/worse health.
Time frame: 4 weeks
PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including physical function. Higher scores indicate more severity/worse health.
Sara Till, MD, MPH
Other
Acronym: CII-CPP
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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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