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临床试验/NCT02220205
NCT02220205已完成不适用

Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice

研究概览

简要总结

Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them. Physicians, physician assistant, and nurse practitioners often learn how to do so by first learning about IUDs, then practicing on a model that the IUD manufacturer provides.

Educators have recently been using more sophisticated models to teach clinical skills such as surgical procedures. We are investigating whether these models may be more useful in teaching IUD insertion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • First-year residents in obstetrics and gynecology or family medicine, or student in physician assistant or nurse practitioner training programs
  • Trainees who have performed <5 intrauterine device insertions
  • Trainees who plan to provide intrauterine devices in their clinical practice

排除标准

  • 未提供

结局指标

主要结局

Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice

时间窗: Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice

Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again. Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better.

次要结局

  • Percent Change in Comfort Placing IUDs From Pre- to Post-insertion(Baseline to three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siripanth Nippita

Instructor in Obstetrics, Gynecology and Reproductive Biology

Beth Israel Deaconess Medical Center

研究点 (2)

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