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

Not Applicable

Not yet recruiting

• Conditions: Vulvodynia (Chronic Vulvar Pain); Vulvar Vestibulitis; Vestibulodynia; Provoked Vestibulodynia; Provoked Localized Vulvodynia

• Registration Number: NCT06999395
• Lead Sponsor: Queen's University

Brief 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

Detailed Description

The primary aim of the proposed single-centre randomized controlled trial is to examine the efficacy of a virtual multimodal 12-week program for individuals with provoked vestibulodynia (PVD, diagnosed by a healthcare provider) compared with a waitlist control group (i.e., participants who are on the waitlist to receive treatment). We hypothesize that participation in the program will result in greater improvements in our primary outcomes of pain and sexual wellbeing for persons with PVD immediately post-treatment and at 3-month follow-up compared to the control group. Our secondary aim is to compare outcomes of the program versus control group on secondary measures of pain catastrophizing, pain self-efficacy, interference (on sexual life and life in general), perceived improvement, and treatment satisfaction. We hypothesize that participants in the program will report greater improvements in these outcomes compared to participants on the waitlist . We will also collect information on adverse events, progress through the program, and thoughts about the program.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Study Start: 2025-07
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sexual insertional pain	Baseline, 12 weeks (immediate post-treatment), 3-month follow-up	0 (no pain) to 10 (extreme pain) rating for pain experienced during sexual activities involving vaginal insertion. Higher scores indicate higher pain intensity (worse outcomes).
Nonsexual insertional pain	Baseline, 12 weeks (immediate post-treatment), 3-month follow-up	0 (no pain) to 10 (extreme pain) rating for pain experienced during nonsexual activities involving vaginal insertion. Higher scores indicate higher pain intensity (worse outcomes).
Provoked vulvar pain by pressure/contact	Baseline, 12 weeks (immediate post-treatment), 3-month follow-up	0 (no pain) to 10 (extreme pain) rating for pain experienced during activities (sexual or nonsexual) involving pressure or contact to the vaginal opening. Higher scores indicate higher pain intensity (worse outcomes).
Sexual function	Baseline, 12 weeks (immediate post-treatment), 3-month follow-up	Female Sexual Function Index. Range of scores is 2 to 36, with higher scores indicating better sexual function (better outcomes). A score of 26.55 and lower indicates possible sexual dysfunction.
Pain interference on sexual life	Baseline, 12 weeks (immediate post-treatment), 3-month follow-up	The Sexual Function Interference subscale of the Vulvar Pain Assessment Questionnaire-Screening version will be used. Range of scores is 0-24, with higher scores indicating more interference (worse outcome).
Pain related interference on one's life	Baseline, 12 weeks (immediate post-treatment), 3-month follow-up	The activity engagement subscale of the Chronic Pain Acceptance Questionnaire (range 0-66, higher scores indicate higher levels of acceptance, which suggest better outcomes) and the Life Interference subscale of the Vulvar Pain Assessment Questionnaire-Screening version (range 0-24, higher scores indicate more interference, which suggest worse outcomes) will be used.
Participant global ratings of improvement	12 weeks (immediate post-treatment), 3-month follow-up	Scale of 0 (deterioration) to 5 (complete recovery) will be used. Range 0-5, with higher scores indicating more improvement.
Treatment satisfaction	12 weeks (immediate post-treatment), 3-month follow-up	Scale of 0 (completely dissatisfied) to 10 (completely satisfied) will be used. Range of scores, 0-10, with higher scores indicating higher treatment satisfaction.

Secondary Outcome Measures

Name	Time	Method
Pain Catastrophizing	Baseline, 12 weeks (immediate post-treatment), 3-month follow-up	The Pain Catastrophizing Scale will be used. Total scores range from 0-52, with higher scores indicating higher catastrophizing (worse outcomes).
Pain Self-efficacy	Baseline, 12 weeks (immediate post-treatment), 3-month follow-up	The Pain Self-Efficacy Scale will be used. Total scores range from 0-60, with higher scores indicating greater pain self-efficacy (better outcomes).
Sexual distress	Baseline, 12 weeks (immediate post-treatment), 3-month follow-up	The 5 item Sexual Distress Scale will be used. Total scores range from 5-25, with higher scores indicating greater sexual distress (worse outcomes).