A Randomized Comparison of Individual Cognitive-behavioural Therapy and Pelvic Floor Rehabilitation in the Treatment of Provoked Vestibulodynia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- change from baseline in pain with sexual intercourse at 12 weeks
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •fluent in English
- •vulvar pain with attempted vaginal penetration for at least 6 months
- •pain limited to vulvar vestibule during cotton swab test
排除标准
- •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
结局指标
主要结局
change from baseline in pain with sexual intercourse at 12 weeks
时间窗: Baseline, 12 weeks
measured on an 11-point numerical rating scale
次要结局
未报告次要终点
研究者
Dr. Caroline Pukall
Professor
Queen's University