Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Objective Description Group
Participants will be prompted using objective description language during the standard of care hysteroscopy.
干预措施: Objective Descriptive Language (Other)
Anticipated Discomfort Group
Participants will be prompted using anticipated discomfort language during the standard of care hysteroscopy.
干预措施: Anticipated Discomfort Language (Other)
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
Jose Carugno
Associate Professor Obstetrics and Gynecology Minimally Invasive Gynecology/Robotic Division Director.
University of Miami