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Remote Mindfulness Education PLV

Primary Purpose

Provoked Localized Vulvodynia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness + Education
Education
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Provoked Localized Vulvodynia focused on measuring Mindfulness therapy, Vulvodynia, Vulvar pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mindfulness & Education

Education only

Arm Description

Mindfulness practice using guided HeadSpace medications plus educational materials

Educational materials only

Outcomes

Primary Outcome Measures

Change in Female Sexual Distress Scale (FSDS) at 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.

Secondary Outcome Measures

Change in Tampon Test Pain Scores at 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.

Full Information

First Posted
May 17, 2018
Last Updated
September 21, 2022
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03541512
Brief Title
Remote Mindfulness Education PLV
Official Title
Remote Mindfulness-Education Intervention for Women With Provoked Localized Vulvodynia: A Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Provoked Localized Vulvodynia
Keywords
Mindfulness therapy, Vulvodynia, Vulvar pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness & Education
Arm Type
Active Comparator
Arm Description
Mindfulness practice using guided HeadSpace medications plus educational materials
Arm Title
Education only
Arm Type
Active Comparator
Arm Description
Educational materials only
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness + Education
Other Intervention Name(s)
Mindfulness group
Intervention Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Education
Other Intervention Name(s)
Education group
Intervention Description
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".
Primary Outcome Measure Information:
Title
Change in Female Sexual Distress Scale (FSDS) at 8 weeks
Description
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.
Time Frame
Baseline & 8 weeks
Secondary Outcome Measure Information:
Title
Change in Tampon Test Pain Scores at 8 weeks
Description
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.
Time Frame
Baseline & 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Leclair, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97238
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Mindfulness Education PLV

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