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Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia?

NCT06999395 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-12

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a 3-month online pelvic health program works to improve pain and sexual wellbeing in adult women with chronic genital pain. The main research questions it aims to answer are:

* 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

Conditions

  • Vulvodynia (Chronic Vulvar Pain)
  • Vulvar Vestibulitis
  • Vestibulodynia
  • Provoked Vestibulodynia
  • Provoked Localized Vulvodynia

Interventions

BEHAVIORAL

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).

Sponsors & Collaborators

  • Queen's University

    lead OTHER

Principal Investigators

  • Caroline Pukall, PhD · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-17
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06999395 on ClinicalTrials.gov