A Randomized Controlled Study of Patient Pain Perception With Tenaculum Placement During In-office Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Pain With Tenaculum Placement
研究概览
简要总结
Randomized controlled trial that compares methods of tenaculum placement during intrauterine device insertion and their effect on pain. The two methods being compared are slow tenaculum placement versus tenaculum placement at time of cough. Subjects will be asked to rate their pain using visual analog scale. Primary outcome measured is pain at time of tenaculum placement. Secondary outcomes are overall pain with intrauterine device insertion and provider satisfaction with tenaculum placement.
详细描述
The two commonly described strategies for tenaculum placement, slow versus having the patient cough while the tenaculum is placed are utilized by providers based on preference and/or their previous training. There is no published study that compares these methods to one another. The investigators aim to compare these strategies, slow tenaculum placement versus the cough method, and their effects on pain at time of placement. 96 subjects will be randomized to each method. The subject will be asked to rate their pain using a 100-mm visual analog scale after speculum placement, after tenaculum is placed, and after completion of the procedure. The provider will be asked to rate their satisfaction with tenaculum placement on a Likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3: moderately satisfied, 4: very satisfied, 5: extremely satisfied. All data to be collected using REDCap database.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ages 18 years and older
- •Undergoing intrauterine device placement
- •English or Spanish speaking
排除标准
- •Primary language other than English or Spanish
研究组 & 干预措施
Slow Tenaculum Placement
This group will have their tenaculum placed using the slow method
干预措施: Slow Tenaculum Placement of tenaculum (Other)
Cough Method
This group will have their tenaculum placed using the cough method
干预措施: Cough method for placement of tenaculum (Other)
结局指标
主要结局
Pain With Tenaculum Placement
时间窗: Directly after tenaculum placement
Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
次要结局
- Overall Pain With Intrauterine Device Insertion(Directly after intrauterine device is placed)
- Provider Satisfaction With Tenaculum Placement(Directly after tenaculum is placed)