Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：PelvicSim
Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
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安慰剂比较：Manufacturer model
Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice
大体时间：Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice
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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. |
Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent Change in Comfort Placing IUDs From Pre- to Post-insertion
大体时间：Baseline to three months
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Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.
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Baseline to three months
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合作者和调查者
调查人员
- 首席研究员：Siripanth Nippita, MD, MS、Beth Israel Deaconess Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.