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Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

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ClinicalTrials.gov Identifier: NCT02494934
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Caroline Pukall, Queen's University

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).

Condition or disease Intervention/treatment Phase
Vulvar Vestibulitis Behavioral: cognitive-behavioural therapy Behavioral: physical therapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Individual Cognitive-behavioural Therapy and Pelvic Floor Rehabilitation in the Treatment of Provoked Vestibulodynia
Study Start Date : September 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Cognitive-behavioural therapy
Eight sessions of psychotherapy incorporating cognitive-behavioural and sex therapy interventions.
Behavioral: cognitive-behavioural therapy
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.

Experimental: physical therapy
Eight sessions of physical therapy targeting the pelvic floor muscles.
Behavioral: physical therapy
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 Measures :
  1. change from baseline in pain with sexual intercourse at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    measured on an 11-point numerical rating scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494934


Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: Caroline Pukall, PhD Queen's University

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Responsible Party: Dr. Caroline Pukall, Professor, Queen's University
ClinicalTrials.gov Identifier: NCT02494934     History of Changes
Other Study ID Numbers: 379631
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis