Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 主要终点
- Pain with tenaculum placement assessed using a VAS scale
研究概览
简要总结
The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.
详细描述
IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.
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
- •18 years old and older
- •Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy)
- •English speaking and able to consent
排除标准
- •Incarcerated
- •Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix
结局指标
主要结局
Pain with tenaculum placement assessed using a VAS scale
时间窗: procedure
Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.
次要结局
- Provider perception of patient pain assessed using a VAS scale(procedure)
- Overall pain perception assessed using a VAS scale(procedure)
研究者
Abbey Hardy-Fairbanks
Associate Professor
University of Iowa