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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
Sponsor:
Information provided by (Responsible Party):
Siripanth Nippita, 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.


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
Allocation: Randomized
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

Arm Intervention/treatment
Active Comparator: PelvicSim
Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
Other: PelvicSim
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:


Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Siripanth Nippita, MD, MS Beth Israel Deaconess Medical Center

Responsible Party: Siripanth Nippita, Instructor in Obstetrics, Gynecology and Reproductive Biology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02220205     History of Changes
Other Study ID Numbers: 2014P-000106
First Posted: August 19, 2014    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017
Last Verified: April 2017

Keywords provided by Siripanth Nippita, Beth Israel Deaconess Medical Center:
IUD
training
simulation