Remote Mindfulness Education PLV

November 4, 2023 updated by: Catherine M Leclair, MD, Oregon Health and Science University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97238
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mindfulness & Education
Mindfulness practice using guided HeadSpace medications plus educational materials
Behavioral: Mindfulness + 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".
Other Names:
  • Mindfulness group
Active Comparator: Education only
Educational materials only
Behavioral: Education
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".
Other Names:
  • Education group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Female Sexual Distress Scale (FSDS) at 8 weeks
Time Frame: 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.
Baseline & 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tampon Test Pain Scores at 8 weeks
Time Frame: 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.
Baseline & 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Catherine Leclair, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 4, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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