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.

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Key information

Conditions

Contraceptive Devices, Intrauterine Education, Medical

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PelvicSim

Other

Manufacturer model

Device

Primary outcomes

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

Time frame: 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 outcomes

Percent Change in Comfort Placing IUDs From Pre- to Post-insertion

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Aug 19, 2014
Registry last updated: May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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