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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Sexual insertional pain [Срок оценки: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up]
• Nonsexual insertional pain [Срок оценки: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up]
• Provoked vulvar pain by pressure/contact [Срок оценки: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up]
• Sexual function [Срок оценки: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up]
• Pain interference on sexual life [Срок оценки: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up]
• Pain related interference on one's life [Срок оценки: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up]
• Participant global ratings of improvement [Срок оценки: 12 weeks (immediate post-treatment), 3-month follow-up]
• Treatment satisfaction [Срок оценки: 12 weeks (immediate post-treatment), 3-month follow-up]

Вторичные конечные точки (3)

• Pain Catastrophizing [Срок оценки: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up]
• Pain Self-efficacy [Срок оценки: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up]
• Sexual distress [Срок оценки: Baseline, 12 weeks (immediate post-treatment), 3-month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Sexual Health Research Laboratory — Kingston

Идентификаторы

NCT: NCT06999395 · QueensU-196214 · 196214

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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