Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions
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|ClinicalTrials.gov Identifier: NCT02220205|
Recruitment Status : Completed
First Posted : August 19, 2014
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraceptive Devices, Intrauterine Education, Medical||Other: PelvicSim Device: Manufacturer model||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: PelvicSim
Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
Placebo Comparator: Manufacturer model
Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.
Device: Manufacturer model
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220205
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Siripanth Nippita, MD, MS||Beth Israel Deaconess Medical Center|