Trials Sponsors Conditions Drugs Pricing

Conditions

Provoked Localized Vulvodynia

Keywords

Mindfulness therapyVulvodyniaVulvar pain

Outcome Measures

Primary Outcomes (1)

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.
Baseline & 8 weeks

Secondary Outcomes (1)

Change in Tampon Test Pain Scores at 8 weeks
Baseline & 8 weeks

Study Arms (2)

Mindfulness & Education

ACTIVE COMPARATOR

Mindfulness practice using guided HeadSpace medications plus educational materials

Behavioral: Mindfulness + Education

Education only

ACTIVE COMPARATOR

Educational materials only

Behavioral: Education

Interventions

Mindfulness + EducationBehavioral

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".

Also known as: Mindfulness group

Mindfulness & Education

EducationBehavioral

Eligibility Criteria

Age18 Years - 100 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Oregon Health and Science University
Otherlead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97238, United States

MeSH Terms

Conditions

Vulvodynia

Interventions

MindfulnessEducational Status

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapy

Study Officials

Catherine Leclair, MD
Oregon Health and Science University
PRINCIPAL INVESTIGATOR

Enrollment

46 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 30, 2018

Study Start

May 1, 2018

Actual (reported)

Study Stopped

Remote Mindfulness Education PLV

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Mindfulness & Education

Education only

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Mindfulness & Education

Education only

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations