Provoked Localized Vulvodynia
Conditions
Keywords
Mindfulness therapy, Vulvodynia, Vulvar pain
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
Interventions
BEHAVIORALMindfulness + 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.
BEHAVIORALEducation
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.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed