Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions

Conditions
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Contraceptive Devices, Intrauterine, Education, Medical

Intervention / Treatment
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* Other: PelvicSim
* Device: Manufacturer model


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PelvicSim<br>Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. | Other: PelvicSim<br> <br> |
| Placebo Comparator: Manufacturer model<br>Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. | Device: Manufacturer model<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 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. | Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | 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. | Baseline to three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IUD, training, simulation