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Behavioral Intervention

Remote Mindfulness Education for Vulvodynia

N/A

Waitlist Available

Led By Catherine Leclair, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline & 8 weeks

Awards & highlights

Study Summary

This trial is testing an online education and mindfulness program to see if it can help with vulvodynia pain and anxiety.

Who is the study for?

This trial is for non-pregnant, healthy women over 18 with confirmed provoked localized vulvodynia (PLV) who have experienced pain during intercourse for at least 3 months. Participants need phone and internet access, the ability to use a tampon, and must not be currently receiving sexual counseling or mindfulness training.Check my eligibility

What is being tested?

The study is testing an online program that combines education with mindfulness exercises to help manage pain and anxiety associated with PLV. The effectiveness of this remote intervention will be evaluated through participants' experiences.See study design

What are the potential side effects?

Since the interventions involve non-invasive practices like education and mindfulness training, significant side effects are not expected. However, some individuals might experience discomfort or emotional distress when confronting their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 18, not pregnant, with painful intercourse for 3+ months, diagnosed with PVL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline & 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline & 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline & 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Female Sexual Distress Scale (FSDS) at 8 weeks

Secondary outcome measures

Change in Tampon Test Pain Scores at 8 weeks

Trial Design

2Treatment groups

Active Control

Group I: Mindfulness & EducationActive Control1 Intervention

Mindfulness practice using guided HeadSpace medications plus educational materials

Group II: Education onlyActive Control1 Intervention

Educational materials only

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

973 Previous Clinical Trials

6,845,983 Total Patients Enrolled

Catherine Leclair, MDPrincipal InvestigatorOregon Health and Science University

3 Previous Clinical Trials

199 Total Patients Enrolled

Media Library

Remote Mindfulness Education PLV (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03541512 — N/A

Localized Vulvodynia Research Study Groups: Mindfulness & Education, Education only

Localized Vulvodynia Clinical Trial 2023: Remote Mindfulness Education PLV Highlights & Side Effects. Trial Name: NCT03541512 — N/A

Remote Mindfulness Education PLV (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03541512 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to take part in this medical experiment?

"This clinical study is looking to accomodate 46 patients suffering from provoked, localized vulvodynia and aged between 18-100 years old."

Answered by AI

Is geriatric recruitment being facilitated for this experiment?

"The age range for potential study participants is between 18 years old and a century."

Answered by AI

Are there any enrolment opportunities for this experiment yet?

"According to clinicaltrials.gov, this medical study is not currently accepting test subjects. The trial was first posted on May 1st 2018 with its last update being made September 21st 2022. Even though no participants are accepted presently, there are 11 other active trials looking for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Remote Mindfulness Education PLV

Catherine M Leclair, MD 2018. "Remote Mindfulness Education PLV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03541512.

All > Vulvodynia