Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with provoked vestibulodynia. This study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. All aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in English, and experience pain due to provoked vestibulodynia for at least 3 months with a physician diagnosis. Participants are expected to continue their treatment as usual and this information will be documented throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18 years or older
- •fluent in English
- •have a formal diagnosis of PVD for at least 3 months
排除标准
- •younger than 18 years of age
- •nonfluent in English
- •self-identified diagnosis
- •PVD duration of less than 3 months
研究组 & 干预措施
3 month PelvicSense(R) program
PelvicSense® is a home-based physiotherapy program integrating multiple techniques, including relaxation, breathing, stretching, strengthening and at-home manual therapy. This program also educates participants about the anatomy and physiology of the pelvis and teaches strategies to strengthen the mind-muscle connection to the pelvis.
干预措施: PelvicSense(R) (Behavioral)
结局指标
主要结局
Pain intensity
时间窗: 3 months after the end of the program
Pain Intensity Numerical Rating Scale (NRS). Participants will be asked to report their pain intensity on an 11-point numerical scale of 0 (no pain) to 10 (worst pain ever felt).
Pain intensity
时间窗: Baseline
Pain Intensity Numerical Rating Scale (NRS). Participants will be asked to report their pain intensity on an 11-point numerical scale of 0 (no pain) to 10 (worst pain ever felt).
Pain intensity
时间窗: At the end of the 3 month program
Pain Intensity Numerical Rating Scale (NRS). Participants will be asked to report their pain intensity on an 11-point numerical scale of 0 (no pain) to 10 (worst pain ever felt).
次要结局
- Pain catastrophizing(3 months after the end of the program)
- Pain catastrophizing(Baseline)
- Pain catastrophizing(At the end of the 3 month program)
研究者
Dr. Caroline Pukall
Professor
Queen's University