Remote Mindfulness Education PLV

Официальное название

Remote Mindfulness-Education Intervention for Women with Provoked Localized Vulvodynia: a Randomized Clinical Study

Обзор

This is a study designed to learn more about the use of an online remote education and mindfulness practice program for the pain and anxiety associated with provoked localized vulvodynia.

Подробное описание

The purpose of study is to evaluate the effectiveness of a remotely delivered mindfulness intervention combined with education for the treatment of the pain and distress associated with Provoked Localized Vulvodynia (PLV). Women with PLV will be randomized to either an app- based mindfulness program (Headspace®) with online education or online education only. Pain and sexual distress with be evaluated through a number of measures. The primary outcome of the study will be the change in distress relating to sexual activity over the 8-week intervention period, which will be measured by a change (reduction) in the Female Sexual Distress Scale (FSDS). Participants will additionally perform a weekly Tampon Test and fill out a weekly survey regarding their perceived pain as well as the frequency of use and completion of the weekly education materials

Вмешательства

• Поведенческое Mindfulness + Education
  Women in the mindfulness + education group will be asked to meditate daily, 10 minutes a day for the first 4 weeks with the option to increase their time to 20 minutes daily during the second 4 weeks. Women will also receive educational materials each week addressing different themes such as; "Introduction and Overview", "The Vulva", "Provoked Localized Vulvodynia (PLV)", "Treatment of PVL", "The Pelvic Floor", "Sexuality", "Chronic Pain", and "Promoting Sexual Health".
• Поведенческое Education
  Women will also receive educational materials each week addressing different themes such as; "Introduction and Overview", "The Vulva", "Provoked Localized Vulvodynia (PLV)", "Treatment of PVL", "The Pelvic Floor", "Sexuality", "Chronic Pain", and "Promoting Sexual Health".

Первичные конечные точки

• Change in Female Sexual Distress Scale (FSDS) at 8 weeks [Срок оценки: Baseline & 8 weeks]

Вторичные конечные точки (1)

• Change in Tampon Test Pain Scores at 8 weeks [Срок оценки: Baseline & 8 weeks]

Критерии участия

Критерии включения

• Reported dyspareunia for at least 3 months in non-pregnant, healthy women over aged 18 years old and estrogen replete with confirmed diagnosis of provoked localized vulvodynia (PVL) or positive Q-tip test, meeting Friedrich's criteria for PLV.
• Ability to insert a regular Tampax® tampon
• Phone access
• Cellular phone with ability to download applications
• Reliable Internet Access

Критерии исключения

• Pregnancy
• Active sexual counseling or mindfulness training (within 6 months of study)
• Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus, etc).
• Unable or unwilling to complete baseline assessments or agree to be randomized.
• Non-English speaking, as Headspace® is not validated in other languages
• Actively engaged in a meditative practice

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Oregon Health & Science University — Portland

Идентификаторы

NCT: NCT03541512 · 18191

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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