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临床试验/NCT05909579
NCT05909579进行中(未招募)不适用

Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis

Dr. Caroline Pukall2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
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 endometriosis. 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 endometriosis 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

入选标准

  • 18 years or older, fluent in English, and have a formal diagnosis of endometriosis for at least 3 months.

排除标准

  • Younger than 18 years of age, nonfluency in English, self-identified diagnosis, endometriosis duration of less than 3 months.

研究组 & 干预措施

3 month PelvicSense(R) program

Experimental

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).

次要结局

  • Pain catastrophizing(3 months after the end of the program)

研究者

发起方
Dr. Caroline Pukall
申办方类型
Network
责任方
Sponsor Investigator
主要研究者

Dr. Caroline Pukall

Professor

Kingston Health Sciences Centre

研究点 (2)

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