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
|Condition or disease||Intervention/treatment||Phase|
|Vulvar Vestibulitis||Behavioral: cognitive-behavioural therapy Behavioral: physical therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- change from baseline in pain with sexual intercourse at 12 weeks [ Time Frame: Baseline, 12 weeks ]measured on an 11-point numerical rating scale
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
|Principal Investigator:||Caroline Pukall, PhD||Queen's University|