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Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

Primary Purpose

Vulvar Vestibulitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive-behavioural therapy
physical therapy
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Vestibulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • fluent in English
  • vulvar pain with attempted vaginal penetration for at least 6 months
  • pain limited to vulvar vestibule during cotton swab test

Exclusion Criteria:

  • other serious medical, psychiatric, or other pain conditions
  • generalized vulvodynia and/or significant vaginismus (i.e., not able to have at least one finger inserted vaginally)
  • current pregnancy, breastfeeding, or being less than 6 months postpartum
  • unwillingness to abstain from other treatments for their PVD pain during the course of the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Cognitive-behavioural therapy

    physical therapy

    Arm Description

    Eight sessions of psychotherapy incorporating cognitive-behavioural and sex therapy interventions.

    Eight sessions of physical therapy targeting the pelvic floor muscles.

    Outcomes

    Primary Outcome Measures

    change from baseline in pain with sexual intercourse at 12 weeks
    measured on an 11-point numerical rating scale

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2015
    Last Updated
    August 30, 2015
    Sponsor
    Queen's University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02494934
    Brief Title
    Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia
    Official Title
    A Randomized Comparison of Individual Cognitive-behavioural Therapy and Pelvic Floor Rehabilitation in the Treatment of Provoked Vestibulodynia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Queen's University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study was to compare the effectiveness of cognitive behavioural therapy (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked vestibulodynia (PVD).
    Detailed Description
    Provoked vestibulodynia (PVD) is the most common condition leading to painful intercourse and is currently best understood within a biopsychosocial framework. Although the usefulness of non-medical treatment options for vulvar pain is recognized by many, there is limited research investigating the effectiveness of these treatments using a biopsychosocial approach to outcome measurement. Furthermore, there is little evidence to support the mechanisms by which these treatments lead to pain reduction. This study aimed to address these gaps by investigating two non-medical treatment options: individual cognitive-behavioural therapy (CBT) and physical therapy (PT).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vulvar Vestibulitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive-behavioural therapy
    Arm Type
    Experimental
    Arm Description
    Eight sessions of psychotherapy incorporating cognitive-behavioural and sex therapy interventions.
    Arm Title
    physical therapy
    Arm Type
    Experimental
    Arm Description
    Eight sessions of physical therapy targeting the pelvic floor muscles.
    Intervention Type
    Behavioral
    Intervention Name(s)
    cognitive-behavioural therapy
    Intervention Description
    The CBT program was adapted from a previously used group CBT program and included the following procedures: (1) education about PVD; (2) collaborative re-conceptualization of PVD as a multi-factorial pain condition; (3) desensitization exercises; (4) diaphragmatic breathing and other relaxation techniques; (5) discussion about and techniques for increasing sexual desire and arousal; (6) sexual communication skills training; (7) instructions on carrying out PFM exercises; (8) instructions on the use of silicone vaginal dilators to do progressive vaginal penetration activities at home; and (9) informal and formal cognitive restructuring techniques and the use of coping self-statements.
    Intervention Type
    Behavioral
    Intervention Name(s)
    physical therapy
    Intervention Description
    The PT treatment protocol included the following procedures: (1) education about PVD; (2) targeted PFM exercises focused on contraction and relaxation including in-session practice and feedback; (3) manual techniques; (4) surface electromyographic biofeedback (sEMG); (5) progressive vaginal penetration activities through the use of four silicone vaginal dilators of varied diameter; (6) stretches of the hip muscles; (7) deep breathing and global body relaxation exercises; and (8) additional methods of managing pain and counseling about different sexual positions.
    Primary Outcome Measure Information:
    Title
    change from baseline in pain with sexual intercourse at 12 weeks
    Description
    measured on an 11-point numerical rating scale
    Time Frame
    Baseline, 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: fluent in English vulvar pain with attempted vaginal penetration for at least 6 months pain limited to vulvar vestibule during cotton swab test Exclusion Criteria: other serious medical, psychiatric, or other pain conditions generalized vulvodynia and/or significant vaginismus (i.e., not able to have at least one finger inserted vaginally) current pregnancy, breastfeeding, or being less than 6 months postpartum unwillingness to abstain from other treatments for their PVD pain during the course of the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Caroline Pukall, PhD
    Organizational Affiliation
    Queen's University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

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