Remote Mindfulness Education for Vulvodynia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the effectiveness of an online mindfulness program in managing pain and anxiety associated with provoked localized vulvodynia (pain in the vulva area). Participants will either use a mindfulness app along with educational materials or receive only educational materials. This trial suits women who have experienced painful intercourse for at least three months and can use a regular tampon. Participants need a phone, the ability to download apps, and reliable internet access. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance pain management strategies for women.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on mindfulness education for vulvodynia, so it's best to discuss your medications with the trial coordinators.
What prior data suggests that this remote mindfulness education is safe for vulvodynia?
Research has shown that mindfulness programs, like the one in this study, are usually easy for people to handle. For example, a study on the Headspace app, included in the treatment, found that users managed stress better without major side effects. Other studies have demonstrated that online mindfulness activities can improve quality of life and reduce pain without causing harm. Since this trial doesn't use medication and focuses on mindfulness and education, the risks remain very low. Participants in similar programs have reported few or no negative effects, suggesting the treatment is safe for most people.12345
Why are researchers excited about this trial?
Researchers are excited about remote mindfulness education for vulvodynia because it offers a non-invasive, accessible approach to managing pain and discomfort. Unlike traditional treatments such as medications or physical therapy, this method utilizes guided mindfulness practices, which can be done from the comfort of home, reducing barriers to care. Additionally, combining mindfulness with educational materials empowers individuals to better understand and manage their symptoms, potentially improving quality of life without the side effects associated with medication.
What evidence suggests that this remote mindfulness education is effective for vulvodynia?
Research has shown that mindfulness practices can help reduce pain and anxiety for women with provoked localized vulvodynia (PLV). In this trial, participants in the "Mindfulness & Education" arm will engage in mindfulness practice using guided HeadSpace meditations combined with educational materials. Studies have found that mindfulness exercises, such as body scan training, can quickly lessen pain for women with chronic pain. Another study discovered that mindfulness-based group therapy, which includes cognitive behavior techniques and educational support, effectively reduces pain and distress. These findings suggest that learning mindfulness, especially when combined with educational materials, may provide relief for those experiencing PLV.12678
Who Is on the Research Team?
Catherine Leclair, MD
Principal Investigator
Oregon Health and Science University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in an 8-week online mindfulness and education program to address pain and distress associated with Provoked Localized Vulvodynia
Follow-up
Participants are monitored for changes in distress and pain scores after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Remote Mindfulness Education PLV
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor