Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06999395

Examining the Efficacy of a Multimodal Virtual Program on Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia: A Randomized Clinical Trial

Led by Queen's University · Updated on 2026-02-12

250

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether a 3-month online pelvic health program can improve pain and sexual wellbeing in adult women diagnosed with provoked vestibulodynia (PVD), a type of chronic genital pain. The study aims to compare outcomes between women who receive the program immediately and those who wait for treatment. It will assess pain levels, sexual function, pain anxiety, interference with life, participant ratings of improvement, and satisfaction with the program. Participants in the active treatment group will access a virtual multimodal program that includes 20 educational modules on pain science, 11 mindfulness and relaxation exercises, and 45 pelvic and other physical exercises. The program focuses on understanding pelvic health, strengthening the mind-body connection, reducing nervous system overactivation, and promoting pelvic floor muscle relaxation. Those in the waitlist control group will wait three months before receiving the same program and will complete surveys at the same time points as the treatment group. Throughout the study, participants will complete questionnaires measuring sexual and nonsexual pain, sexual function, and pain interference at baseline, immediately after the 12-week program, and at a 3-month follow-up. Researchers will also track pain catastrophizing, self-efficacy, sexual distress, participant ratings of improvement, and treatment satisfaction. The study will monitor progress through the program and any adverse events. Participation involves completing online surveys and using the program at participants' own pace over several months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-reported physician diagnosis of provoked vestibulodynia (PVD)
  • 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
  • Female
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Less than 18 years old
  • Pregnancy or suspected pregnancy
  • Breastfeeding
  • Up to one year postpartum
  • Physical or mental health conditions that significantly interfere with activities of daily living

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for screening and enrollment

Treatment

Duration - 12 weeks

Participants in the active treatment group participate in a 12-week virtual multimodal pelvic health program designed to improve pain and sexual outcomes. Participants in the waitlist control group do not receive treatment during this period but complete the same surveys.

Participants complete surveys at baseline and immediately post-treatment; treatment is self-guided online

Follow-up

Duration - 3 months

Participants complete follow-up assessments 3 months after the end of the treatment period to evaluate the lasting effects of the program or waitlist period.

1 follow-up survey visit (virtual)

Trial Site Locations

Total: 1 location

1

Sexual Health Research Laboratory

Kingston, Ontario, Canada, K7L 3N6

Actively Recruiting

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Research Team

S

Shannon Research Coordinator, MA

M

Marilyn Post-doctoral fellow, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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