A Randomized Controlled Trial of Pain Perception With Fast and Slow Tenaculum Application to the Uterine Cervix
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Pain perception with tenaculum application
研究概览
简要总结
This project will be a randomized controlled trial (RCT) measuring pain perception with two different tenaculum placement techniques on the uterine cervix. A tenaculum is an instrument used to hold the cervix (the opening to the uterus or womb) in place. The trial will measure pain perception with a Visual Analog Scale (VAS) from 0 to 100 mm for two different tenaculum placement techniques, fast and slow closure on the uterine cervix. The main objective of this study is to determine if there is a difference in pain perception with fast compared to slow tenaculum placement techniques on the uterine cervix. We hypothesize that the slow technique will be perceived as less painful for subjects as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). Subsidiary objectives include describing overall pain levels during the procedure.
详细描述
In order to detect a 15 mm difference on the VAS with two-sided 5% alpha and 80% power and a standard deviation of 33 mm (based on prior studies), a total of 71 subjects per group are required. We aim to recruit 75 subjects per arm in order to account for possible drop out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •plans for IUD insertion or endometrial biopsy;
- •18 to 49 years of age;
- •not taken analgesics or anxiolytics in the previous 24 hours;
- •the ability and are willing to give informed consent.
排除标准
- •Do not speak English unless interpreter present;
- •Taken any narcotic or opiate medication in the last 24 hours.
- •Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines.
- •Taken any anti-anxiety medication or drug in the last 24 hours.
- •Taken any NSAIDS or Tylenol in the last 12 hours.
结局指标
主要结局
Pain perception with tenaculum application
时间窗: during procedure
Pain scores will be determined using the Visual Analog Scale (VAS) from 0 to 100 mm.
次要结局
未报告次要终点