Remote Mindfulness Education for Vulvodynia

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Pregnancy, Endometriosis, Chronic pelvic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

46 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Remote Mindfulness Education PLV for vulvodynia?

Research shows that mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) effectively reduce pain and improve sexual function in women with provoked vestibulodynia, a condition similar to vulvodynia. This suggests that mindfulness education, a component of these therapies, may also be beneficial for vulvodynia. ^{1 2 3 4 5}

Is remote mindfulness education safe for humans?

The studies reviewed do not specifically address the safety of remote mindfulness education, but mindfulness-based therapies, in general, are considered safe and have been used effectively for various conditions. ^{1 2 5 6 7}

How is Remote Mindfulness Education PLV treatment different from other treatments for vulvodynia?

Remote Mindfulness Education PLV is unique because it focuses on teaching mindfulness techniques remotely, which can help manage pain and stress associated with vulvodynia. Unlike traditional treatments that may involve medication or physical therapy, this approach emphasizes mental and emotional well-being through mindfulness practices. ^{8 9 10 11 12}

Research Team

Catherine Leclair, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

You have a cell phone that can download apps.

You should be able to use a Tampax® tampon without any difficulty.

Reliable Internet Access

Exclusion Criteria

Pregnancy

I experience pain during intercourse due to conditions like endometriosis or skin issues.

I regularly practice meditation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week online mindfulness and education program to address pain and distress associated with Provoked Localized Vulvodynia

8 weeks

Weekly online activities

Follow-up

Participants are monitored for changes in distress and pain scores after the intervention

4 weeks

Treatment Details

Interventions

• Remote Mindfulness Education PLV

Trial Overview 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.

Participant Groups

Group I: Mindfulness & Education Active Control 1 Intervention

Mindfulness practice using guided HeadSpace medications plus educational materials

Group II: Education only Active Control 1 Intervention

Educational materials only

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Findings from Research

The TtLIVE virtual care solution, designed for patients transitioning to home mechanical ventilation, is being evaluated in a randomized controlled trial with 440 participants to assess its effectiveness compared to usual care, focusing on emergency department visits and caregiver well-being over 12 months.

This study will also analyze healthcare utilization, caregiver burden, and quality of life, while exploring the acceptability of the TtLIVE intervention through qualitative interviews, providing comprehensive insights into both clinical and experiential outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. Amin, R., Gershon, A., Buchanan, F., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Moderators of Improvement From Mindfulness-Based vs Traditional Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Experiences of internet-based treatment for vulvodynia: A qualitative study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Group Cognitive Behavior Therapy for Provoked Localized Vulvodynia: A Randomized Controlled Trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Psychosocial Factors Influence Sexual Satisfaction among Women with Vulvodynia. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Internet-based Treatment for Vulvodynia (EMBLA) - A Randomized Controlled Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of an Online Mindfulness-Based Intervention for Women with Sexual Interest/Arousal Disorder. [2022]

7. Scotland pubmed.ncbi.nlm.nih.gov

Web-based education about vulvodynia and its care among student healthcare staff: A quasi-experimental study. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Pediatric long-term home mechanical ventilation: twenty years of follow-up from one Canadian center. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Understanding living with tracheostomy ventilation for motor neuron disease and the implications for quality of life: a qualitative study protocol. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Experiences and views of patients, carers and healthcare professionals on using modems in domiciliary non-invasive ventilation (NIV): a qualitative study. [2021]

11. Italy pubmed.ncbi.nlm.nih.gov

Telemonitoring in chronic ventilatory failure: a new model of survellaince, a pilot study. [2016]

12. England pubmed.ncbi.nlm.nih.gov

The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. [2022]