Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia?
NCT ID: NCT06999395
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2025-07-31
2028-12-31
Brief Summary
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* How well does the program work to improve pain and sexual wellbeing?
* How well does the program work to improve pain anxiety and pain interference?
* How do participants rate their improvement after completing the program?
* How satisfied are participants with the program?
Researchers will compare participants who receive the program right away to those who wait for the program. Participants who receive the program right away will
* Progress through the program at their own pace
* Learn about pain science, do pelvic health exercises, and use information to be more mindful and less anxious about the pain
* Answer questions about their pain experiences and sexual wellbeing before and after the 3-month program, as well as 3 months after the end of the program
* Provide information about their experiences with the program and progress through the program during and after the program
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Active treatment
Participants in the active treatment arm will receive access to the program once determined eligible.
Virtual online pelvic health program
The program offers a multimodal approach to self-guided treatment for PVD. Its multimodal approach is exemplified by pain education focusing on pelvic health and neuroplasticity to provide the foundation for strategies strengthening the mind-body connection to the pelvis; mindful breathing and relaxation exercises to reduce nervous system overactivation and enhance mood; and gradual progression of exercises encouraging awareness, stretching, and strengthening to promote relaxation of the pelvic floor muscles and reduction of accessory muscle tension resulting from protective guarding. The program uses 3 separate yet interconnected modules: Learn (20 modules of pain science education and skills), Rewire (11 modules featuring mindfulness and relaxation), and Move (45 pelvic and other exercises).
Waitlist control
Participants in the waitlist control group will wait 3 months for access to the program. As the wait, they will receive the same surveys at the same timepoints as the active treatment group.
No interventions assigned to this group
Interventions
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Virtual online pelvic health program
The program offers a multimodal approach to self-guided treatment for PVD. Its multimodal approach is exemplified by pain education focusing on pelvic health and neuroplasticity to provide the foundation for strategies strengthening the mind-body connection to the pelvis; mindful breathing and relaxation exercises to reduce nervous system overactivation and enhance mood; and gradual progression of exercises encouraging awareness, stretching, and strengthening to promote relaxation of the pelvic floor muscles and reduction of accessory muscle tension resulting from protective guarding. The program uses 3 separate yet interconnected modules: Learn (20 modules of pain science education and skills), Rewire (11 modules featuring mindfulness and relaxation), and Move (45 pelvic and other exercises).
Eligibility Criteria
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Inclusion Criteria
* PVD duration of at least 3 months
* PVD pain intensity rating of at least 3 on a scale from 0 (no pain) to 10 (extreme pain)
* Resides in North America (Canada or the United States)
* Fluent in English
Exclusion Criteria
* Pregnancy or suspected pregnancy
* Breastfeeding
* Up to one year postpartum
* Physical or mental health conditions that significantly interfere with activities of daily living
18 Years
FEMALE
No
Sponsors
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Queen's University
OTHER
Responsible Party
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Dr. Caroline Pukall
Professor
Principal Investigators
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Caroline Pukall, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Central Contacts
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Other Identifiers
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196214
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
QueensU-196214
Identifier Type: -
Identifier Source: org_study_id