Remote Mindfulness Education PLV
- Conditions
- Provoked Localized Vulvodynia
- Interventions
- Behavioral: Mindfulness + EducationBehavioral: Education
- Registration Number
- NCT03541512
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 46
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness & Education Mindfulness + Education Mindfulness practice using guided HeadSpace medications plus educational materials Education only Education Educational materials only
- Primary Outcome Measures
Name Time Method Change in Female Sexual Distress Scale (FSDS) at 8 weeks Baseline & 8 weeks The change in distress relating to sexual activity, measured by a change in the FSDS from baseline (study enrollment) survey. Participants will complete a Female Sexual Distress Scale (FSDS) survey to rate their feelings associated with sexual activities. Survey questions are on a number scale of 0 (Never) to 4 (Always). The FSDS surveys will be completed at baseline and 8 weeks after study enrollment.
- Secondary Outcome Measures
Name Time Method Change in Tampon Test Pain Scores at 8 weeks Baseline & 8 weeks The change in tampon test pain scores (a validated tool that measures introital pain). The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (pain as bad as you can imagine). This test will occur at baseline and 8 weeks after enrollment.
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States