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NCT03541512

Remote Mindfulness Education PLV

Enrolling by Invitation
NAAges 18+InterventionalSupportive care
Oregon Health and Science University
~46 participants
Updated 2025-03-24 on ClinicalTrials.gov
What's tested:Mindfulness + EducationEducation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Female Sexual Distress Scale (FSDS) at 8 weeks
Measured over Baseline & 8 weeks

Conditions

Provoked Localized Vulvodynia

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Provoked Localized Vulvodynia

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Catherine Leclair, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Female Sexual Distress Scale (FSDS) at 8 weeksBaseline & 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.