Integrated Mindfulness for Provoked Vestibulodynia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This study aims to test the efficacy of a 4-session intervention (Group psychoeducational treatment) using a randomized study design. Participants will be randomized in to 'immediate treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session IMPROVED treatment, just as women randomized to the experimental group, after the end of their wait-list period.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •must be a patient at the British Columbia Centre for Sexual Medicine
- •diagnosis of provoked vestibulodynia (PVD)
- •19 years of age or older
- •premenopausal
- •fluent in English
排除标准
- •not at patient at the BC Centre for Sexual Medicine
- •unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain
- •being uncomfortable and unwilling to participate in a group setting.
研究组 & 干预措施
Immediate treatment
Women in the Immediate treatment arm will receive the Group Psychoeducational treatment in the next available group. There will be 8-9 womenper group and each session will be 2.25 hours in duration and there will be 4, bi-weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.
干预措施: Group Psychoeducational Treatment (Behavioral)
Waitlist Control- delayed treatment
Women in the Waitlist Control arm will receive no treatment for a period of approximately 8 weeks. After the waitlist period they will receive the same Group Psychoeducational treatment as the participants in the immediate treatment arm of the study.
干预措施: Waitlist control (Other)
结局指标
主要结局
Pain intensity
时间窗: one week pre-treatment to one week post treatment
Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch.
Long-term pain intensity
时间窗: One week pre-treatment to 6 months post preatment
Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch
次要结局
- Sexual Distress(One week pre-treatment, one week post treatment and 6-months follow up)
研究者
Lori Brotto
Principal Investigator
University of British Columbia