临床试验/NCT02878135

NCT02878135已完成不适用

the Effect of Slow Versus Fast Application of Vulsellum on Pain Perception During Intrauterine Device Insertion

Assiut University2 个研究点分布在 1 个国家目标入组 200 人开始时间: 2016年10月最近更新: 2017年8月1日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Assiut University
入组人数: 200
试验地点: 2
主要终点: mean Pain score with vulsellum placement

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's often complain that its placement is one of the most uncomfortable parts of this procedure

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
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

•Women not taken analgesics or anxiolytics in the 24 hours prior insertion
•Women not taken misoprostol prior to intrauterine device insertion
•Women who will accept to participate in the study

排除标准

•Any contraindication to intrauterine device placement

研究组 & 干预措施

fast vulsellum

Experimental

rapid ratchet of the vulsellum

干预措施: fast application (Procedure)

slow vulsellum

Active Comparator

Placement of the tenaculum over 7-10 seconds and not allowing the vulsellum to ratchet audibly.

干预措施: slow application (Procedure)

结局指标

主要结局

mean Pain score with vulsellum placement

时间窗: 5 minutes

次要结局

未报告次要终点

研究者

发起方

Assiut University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Ahmed Mohamed Abbas

Assiut University

研究点 (2)

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