Provoked Localized VulvodyniaNCT03541512
Remote Mindfulness Education PLV
A study testing Mindfulness + Education and Education in people with Provoked Localized Vulvodynia, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Provoked Localized Vulvodynia
- What is being tested?
- Mindfulness + Education and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97238
About this study
Official title: 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.
Read the 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
- Conditions
- Provoked Localized Vulvodynia
- Being tested
- Mindfulness + Education, Education
- Keywords
- Mindfulness therapy, Vulvodynia, Vulvar pain
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness + EducationBehavioural
Also called Mindfulness group
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".
EducationBehavioural
Also called Education group
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".
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness & Education | Active comparator | Mindfulness practice using guided HeadSpace medications plus educational materials Receives: Behavioral: Mindfulness + Education |
| Education only | Active comparator | Educational materials only Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline & 8 weeks
Secondary outcomes (1)
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.
Measured: Baseline & 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 May 2018
- Primary completion1 Sep 2026
- Study completion30 Sep 2026
Why it stopped: COVID changed the nature in which this study had value.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Provoked Localized VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine M Leclair, MD, Oregon Health and Science University
- Investigators
- Catherine Leclair, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541512
- Sponsor's protocol ID
- 18191
- Status last verified
- Oct 2026
- First submitted
- 17 May 2018
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Mindfulness-Education Intervention for Women With Provoked Localized Vulvodynia: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03541512
- Acronym / sponsor ID
- 18191
- Conditions
- Provoked Localized Vulvodynia
- Keywords
- Mindfulness therapy, Vulvodynia, Vulvar pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID changed the nature in which this study had value.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness & Education | Active comparator | Behavioral: Mindfulness + EducationMindfulness practice using guided HeadSpace medications plus educational materials |
| Education only | Active comparator | Behavioral: EducationEducational materials only |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness + EducationAlso: Mindfulness groupWomen 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". | Behavioural | Mindfulness & Education |
| EducationAlso: Education groupWomen 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". | Behavioural | Education only |
Primary outcome
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.
1 secondary outcome
Change in Tampon Test Pain Scores at 8 weeks
Time frame: Baseline & 8 weeks
Results and safety
The study was stopped early (reason given: COVID changed the nature in which this study had value.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Provoked Localized Vulvodynia
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Recruiting
Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia?
Vulvodynia (Chronic Vulvar Pain), Vulvar Vestibulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Leclair, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness + Education and Education in people with Provoked Localized Vulvodynia, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID changed the nature in which this study had value.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Female Sexual Distress Scale (FSDS) at 8 weeks (time frame: Baseline & 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.