Integrated Mindfulness for Provoked Vestibulodynia

Provoked Vestibulodynia Clinical Trial

— IMPROVED  

Official title:

Integrated Mindfulness for Provoked Vestibulodynia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704443
• Other study ID #: H08-00885
• Status: Completed
• Phase: N/A
• First received: August 24, 2012
• Last updated: May 30, 2017
• Start date: April 2008
• Est. completion date: April 2013

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Provoked Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Behavioral:
• Group 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)

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

Locations

Country	Name	City	State
Canada	British Columbia Centre for Sexual Medicine	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Catastrophising	The investigators will examine women's self-reported pain catastrophising by administering the Pain Catastrophizing Scale (Sullivan, Bishop & Pivik, 1995).	one week pre-treatment, one week post treatment and 6-months follow-up
Other	Pain hypervigilance	The investigators will examine women's self-report hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire, McCracken, 1997)	one week pre-treatment, one week post treatment and 6-months follow-up
Primary	Pain intensity	Pain 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.	one week pre-treatment to one week post treatment
Primary	Long-term pain intensity	Pain 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	One week pre-treatment to 6 months post preatment
Secondary	Sexual Distress	The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised (Derogatis et al, 2008)	One week pre-treatment, one week post treatment and 6-months follow up