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临床试验/NCT02913027
NCT02913027已完成不适用

Can We Improve the Comfort of Pelvic Exams?

Philadelphia Urosurgical Associates0 个研究点目标入组 200 人开始时间: 2016年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
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 the self-reported comfort during each section of the pelvic exam and how comfort during the exam relates to quality of life, self-esteem, and sexual function in English speaking females at least 18 years of age in an outpatient setting.

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
Single (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

入选标准

  • English-speaking, female patients
  • Are able to can read and write English
  • Are utilizing outpatient services at an OBGYN outpatient office
  • Are scheduled for a well-woman exam

排除标准

  • Non-English speaking patients
  • Patients who cannot read or write
  • Those who are pregnant
  • Have an active vaginal infection
  • Patients who, otherwise, do not require a speculum exam during their appointment

结局指标

主要结局

Visual Analog Score: A change of 13mm

时间窗: Within 1 hour of the exam

次要结局

  • Wellbeing quality of life score: Range 0-4.(Within 1 hour of the exam)
  • Female Sexual Function Index-19(Within 1 hour of the exam)
  • Rosenberg Self-Esteem Score: Scale 10-40(Within 1 hour of the exam)

研究者

发起方
Philadelphia Urosurgical Associates
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristene Whitmore

Physician

Philadelphia Urosurgical Associates

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