Remote Mindfulness Education PLV

Conditions

• Provoked Localized Vulvodynia

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Mindfulness + Education — BEHAVIORAL
  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".
• Education — BEHAVIORAL
  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 Details

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.

Key Dates

Start date

May 1, 2018

Status verified

Mar 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

46 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Mindfulness & Education
  Mindfulness practice using guided HeadSpace medications plus educational materials
• Active Comparator: Education only
  Educational materials only

Primary Outcome Measure

Change in Female Sexual Distress Scale (FSDS) at 8 weeks [ Time Frame: Baseline & 8 weeks ]

Locations (1)

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