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Integrated Mindfulness for Provoked Vestibulodynia

Integrated Mindfulness for Provoked Vestibulodynia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01704443
Acronym
IMPROVED
Enrollment
97
Registered
2012-10-11
Start date
2008-04-30
Completion date
2013-04-30
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Provoked Vestibulodynia

Keywords

provoked vestibulodynia, dyspareunia, vulvodynia, mindfulness, cognitive behavioural therapy

Brief summary

This study aims to test the efficacy of a 4-session intervention (Group psychoeducational treatment) using a randomized study design. Participants will be randomized in to 'immediate treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session IMPROVED treatment, just as women randomized to the experimental group, after the end of their wait-list period.

Interventions

BEHAVIORALGroup Psychoeducational Treatment

The Group Psychoeducational Treatment consists of treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be four, bi-weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain. Participants in the Waitlist Control Condition will receive this treatment at the end of the waitlist period (approximately 8 weeks)

OTHERWaitlist control

No treatment will be provided during the 8 week Waitlist control period

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* must be a patient at the British Columbia Centre for Sexual Medicine * diagnosis of provoked vestibulodynia (PVD) * 19 years of age or older * premenopausal * fluent in English

Exclusion criteria

* not at patient at the BC Centre for Sexual Medicine * unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain * being uncomfortable and unwilling to participate in a group setting.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityone week pre-treatment to one week post treatmentPain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch.
Long-term pain intensityOne week pre-treatment to 6 months post preatmentPain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch

Secondary

MeasureTime frameDescription
Sexual DistressOne week pre-treatment, one week post treatment and 6-months follow upThe investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised (Derogatis et al, 2008)

Other

MeasureTime frameDescription
Pain Catastrophisingone week pre-treatment, one week post treatment and 6-months follow-upThe investigators will examine women's self-reported pain catastrophising by administering the Pain Catastrophizing Scale (Sullivan, Bishop & Pivik, 1995).
Pain hypervigilanceone week pre-treatment, one week post treatment and 6-months follow-upThe investigators will examine women's self-report hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire, McCracken, 1997)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026