跳至主要内容
临床试验/NCT05316506
NCT05316506已完成不适用

Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial

University of Miami2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Change in Pain as measured by Visual Analog Scale (VAS)

研究概览

简要总结

The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, 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

  • Adults 18 years of age and older
  • Scheduled for in office hysteroscopy
  • Able to consent for the study in English or Spanish

排除标准

  • Persons with preexisting conditions that may alter pain perception (ie. active vulvo-vaginal infection, vulvodynia, genital lesions, chronic pain conditions)
  • Previous in-office hysteroscopy
  • Hysteroscopy for foreign body/ Intrauterine Device (IUD) removal
  • Minors, prisoners, or other members of vulnerable populations
  • Patients who cannot communicate in English or Spanish

结局指标

主要结局

Change in Pain as measured by Visual Analog Scale (VAS)

时间窗: Baseline (pre-procedure), Day 1 (post-procedure)

Pain will be assessed using the Visual Analog Scale (VAS). Visual Analog Scale (VAS) is score from 0 (no pain) to 10 (worst pain imaginable).

次要结局

  • Number of participants in each pain category(Day 1 (post-procedure))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Carugno

Associate Professor Obstetrics and Gynecology Minimally Invasive Gynecology/Robotic Division Director.

University of Miami

研究点 (2)

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