Remote Mindfulness Education PLV
Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · May 17, 2018
Trial Information
Current as of July 09, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 chang...
Gender
FEMALE
Eligibility criteria
- 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
About Oregon Health And Science University
Oregon Health and Science University (OHSU) is a leading academic medical center dedicated to advancing health through research, education, and patient care. As a prominent sponsor of clinical trials, OHSU leverages its extensive expertise in various medical fields to facilitate innovative research aimed at improving patient outcomes. The institution is committed to ethical standards and rigorous scientific methodologies, fostering collaborations that enhance the development of new therapies and interventions. With a focus on translating research discoveries into clinical practice, OHSU plays a pivotal role in shaping the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Portland, Oregon, United States
Patients applied
Trial Officials
Catherine Leclair, MD
Principal Investigator
Oregon Health and Science University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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