Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions

Not Applicable

Completed

• Conditions: Contraceptive Devices, Intrauterine; Education, Medical

• Registration Number: NCT02220205
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-19
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-07-27
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-21
• Last Update Submitted: 2017-04-21
• Results First Posted: 2017-05-24
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice	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.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Comfort Placing IUDs From Pre- to Post-insertion	Baseline to three months	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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States