Remote Mindfulness Education PLV

Oregon Health & Science University (OHSU)

Status

Invitation-only

Conditions

Provoked Localized Vulvodynia

Treatments

Behavioral: Mindfulness + Education

Behavioral: Education

Study type

Interventional

Funder types

Other

Identifiers

NCT03541512

18191

Details and patient eligibility

About

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.

Full 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

Enrollment

46 estimated patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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