Remote Mindfulness Education PLV

Study Overview
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Brief Summary
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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
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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

Official Title
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Remote Mindfulness-Education Intervention for Women With Provoked Localized Vulvodynia: A Randomized Clinical Study

Conditions
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Provoked Localized Vulvodynia

Intervention / Treatment
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* Behavioral: Mindfulness + Education
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness & Education<br>Mindfulness practice using guided HeadSpace medications plus educational materials | Behavioral: Mindfulness + Education<br>* 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.<br>* Other names: Mindfulness group;|
| Active Comparator: Education only<br>Educational materials only | Behavioral: Education<br>* 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.<br>* Other names: Education group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Female Sexual Distress Scale (FSDS) at 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. | Baseline & 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tampon Test Pain Scores at 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. | Baseline & 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness therapy, Vulvodynia, Vulvar pain