Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions

Education, Medical Clinical Trial

Official title:

Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220205
• Other study ID #: 2014P-000106
• Status: Completed
• Phase: N/A
• First received: August 14, 2014
• Last updated: May 18, 2015
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Contraceptive Devices, Intrauterine
• Education, Medical

Intervention

Other:
• PelvicSim

Device:
• Manufacturer model

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IUD insertion score	Participants will be videotaped three months after the initial study visit performing three IUD insertions each for the three devices currently available in the US. We will compare the scores from the initial study visit with those from the three month follow-up study visit.	3 months	No
Primary	Insertion score change	Participants are filmed performing 3 IUD insertions each, for each of the three IUDs currently available in the US. They then practice on an assigned simulator for 30 minutes, and are re-recorded immediately afterwards. Both sets of insertions are scored using a standardized checklist. We are looking for a change in this score before and immediately after practice on the simulator.	Before and immediately after initial practice on assigned simulator (same day)	No
Secondary	Comfort/competency	Participants are given questionnaires at the initial study visit and at a three-month follow-up visit that assess their comfort and self-perceived competency with IUD insertion. We will compare the difference in scores over three months.	3 months	No