Remote Mindfulness Education PLV



Status:Enrolling by invitation
Healthy:No
Age Range:18 - 100
Updated:6/1/2018
Start Date:May 1, 2018
End Date:May 2019

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

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.

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

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
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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mi
from
Portland, OR
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