The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Visual Analog Score: A change of 13mm
研究概览
简要总结
The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.
详细描述
The purpose of this randomized controlled trial is to investigate the sequence in which physicians perform the pelvic exam, describe and compare self-reported comfort during each section of the pelvic exam and how comfort during the examinations related to quality of life, self-esteem, and sexual function in English speaking females at least 18 years of age with chronic vulvovaginal conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English Speaking Are able to read and write English Are utilizing outpatient services and being seen for a first appointment at an outpatient Vulvodynia Center
排除标准
- •Non English Speaking
- •Patients who cannot read or write
- •Those who are pregnant
- •Those who do not have a chronic vulvovaginal condition
- •Patients other than "new" patients
- •Patients who would not otherwise need a speculum exam
研究组 & 干预措施
Observational
Normal pelvic exam exposures: External exam followed by speculum exam, followed by bimanual exam
Experimental Pelvic Exam
Changing the order of the pelvic exam Intervention: External exam, bimanual exam,speculum exam
干预措施: Experimental Pelvic Exam (Diagnostic Test)
结局指标
主要结局
Visual Analog Score: A change of 13mm
时间窗: Within 1 hour of the exam
ale from 0-10, measured in mm. A change from baseline of 13mm is considered a significant change
次要结局
- Female Sexual Function Index-19(Within 1 hour of the exam)
- Rosenberg Self-esteem Score: Scale 10-40(Within 1 hour of the exam)
- Wellbeing quality of life score: Range 0-4(Within 1 hour of the exam)
研究者
Rebecca Rinko
Dr. Rebecca Rinko
Drexel University