NCT03541512

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
May 2018Jul 2026

Study Start

First participant enrolled

May 1, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

8.2 years

First QC Date

May 17, 2018

Last Update Submit

March 19, 2025

Conditions

Provoked Localized Vulvodynia

Keywords

Mindfulness therapyVulvodyniaVulvar pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline & 8 weeks

Secondary Outcomes (1)

  • Change in Tampon Test Pain Scores at 8 weeks

    Baseline & 8 weeks

Study Arms (2)

Mindfulness & Education

ACTIVE COMPARATOR

Mindfulness practice using guided HeadSpace medications plus educational materials

Behavioral: Mindfulness + Education

Education only

ACTIVE COMPARATOR

Educational materials only

Behavioral: Education

Interventions

Mindfulness + EducationBEHAVIORAL

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".

Also known as: Mindfulness group
Mindfulness & Education
EducationBEHAVIORAL

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".

Also known as: Education group
Education only

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97238, United States

Location

MeSH Terms

Conditions

Vulvodynia

Interventions

MindfulnessEducational Status

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Catherine Leclair, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 30, 2018

Study Start

May 1, 2018

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)