Clinical Trials Directory

Trials / Completed

CompletedNCT02494934

Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

A Randomized Comparison of Individual Cognitive-behavioural Therapy and Pelvic Floor Rehabilitation in the Treatment of Provoked Vestibulodynia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Queen's University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALcognitive-behavioural therapyThe 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.
BEHAVIORALphysical therapyThe 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.

Timeline

Start date
2009-09-01
Primary completion
2012-04-01
Completion
2012-04-01
First posted
2015-07-10
Last updated
2015-09-01

Source: ClinicalTrials.gov record NCT02494934. Inclusion in this directory is not an endorsement.