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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorQueen's University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Less than 18 years old

Pregnancy or suspected pregnancy

Breastfeeding

Up to one year postpartum

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual online pelvic health program

    Behavioral

    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).

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Active treatmentExperimental treatment 1 intervention
Group B: Waitlist controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Sexual insertional pain

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).

Time frame
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
2

Nonsexual insertional pain

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).

Time frame
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
3

Provoked vulvar pain by pressure/contact

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).

Time frame
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
4

Sexual function

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.

Time frame
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up

Secondary outcomes

1

Pain Catastrophizing

The Pain Catastrophizing Scale will be used. Total scores range from 0-52, with higher scores indicating higher catastrophizing (worse outcomes).

Time frame
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
2

Pain Self-efficacy

The Pain Self-Efficacy Scale will be used. Total scores range from 0-60, with higher scores indicating greater pain self-efficacy (better outcomes).

Time frame
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up
3

Sexual distress

The 5 item Sexual Distress Scale will be used. Total scores range from 5-25, with higher scores indicating greater sexual distress (worse outcomes).

Time frame
Baseline, 12 weeks (immediate post-treatment), 3-month follow-up

Other outcomes

1

Adverse events

Will be collected via an open text box suitable for narrative responses from participants.

Time frame
At 3, 6, and 9 weeks during intervention, 12 weeks (immediate post-treatment), 3-month follow-up

Sponsors and contacts

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