- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499002
Teaching Medical Students How to Suture: Standard Simulation vs in Situ
March 11, 2019 updated by: Memorial University of Newfoundland
The purpose of this project is to compare in situ simulation with standard lab simulation.
To do this, 30 pre-clinical medical students will be randomized into the lab or ER and taught how to suture a simple laceration.
To do this, a synthesized 'skin' will be placed over a volunteer's arm and will have an incision of a predetermined length.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
For this study, 30 first and second year students will be equally randomized to either a standard simulation lab or the ER department to learn the skill of suturing.
These students will not have any knowledge of suturing prior to this study.
Each group will have 15 students.
Each student will be given access to the same suturing learning video.
They will each attempt 15 sutures on a lab generated skin placed over a volunteer's arm.
Each incision length will be predetermined and of the same length.
The student will have the opportunity to re-watch the video in between each suture attempt.
The volunteer will record the student's number of attempts and whether or not they had to review the video.
The idea behind this, is that students should began to plateau with their learning after about 8-9 attempts and most will no longer require the video beyond that.After the 15 attempts, the student will immediately practice 6 sutures on a second skin over the volunteer's arm, again of a predetermined incision length.
At this point the students will only be allowed to practice the suturing skill and will not have access to the learning video.
At this point, the student's hands will be video recorded to assess the accuracy of the skill.One week after the learning session, regardless of the environment they initially learned in, the student will be brought to the ER and again allowed to practice 6 sutures on a simulated skin placed over a volunteer's arm.
The incision will be the same length as the incision in the previous practice session.
Again, the student's hands will be video recorded while practicing the 6 sutures.Afterward, the student will be given a questionnaire regarding which environment they practiced in and how prepared they felt to practice in the insitu environment without learning aids.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pre clinical medical students (year one or two)
Exclusion Criteria:
- Medical students not in first or second year training
- Extensive knowledge or background with suturing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Simulation Lab
|
Intervention is the environment in which the medical student will learn to practice how to suture.
The end goal is to determine the impact each environment has on their ability to learn the skill.
Other Names:
|
Experimental: ER in situ Simulation
|
Intervention is the environment in which the medical student will learn to practice how to suture.
The end goal is to determine the impact each environment has on their ability to learn the skill.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
How each simulated learning environment effects a student's ability to learn how to suture
Time Frame: 1 week
|
Each student will complete a post survey questionnaire after their attempt to suture in the ER department.
This will help determine the impact and therefore, which environment was more conducive to learning how to suture.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chrystal Horwood, MD, Memorial University of Newfoundland and Labrador
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Roussin CJ, Weinstock P. SimZones: An Organizational Innovation for Simulation Programs and Centers. Acad Med. 2017 Aug;92(8):1114-1120. doi: 10.1097/ACM.0000000000001746.
- Jagneaux T, Caffery TS, Musso MW, Long AC, Zatarain L, Stopa E, Freeman N, Quin CC, Jones GN. Simulation-Based Education Enhances Patient Safety Behaviors During Central Venous Catheter Placement. J Patient Saf. 2021 Sep 1;17(6):425-429. doi: 10.1097/PTS.0000000000000425.
- Sorensen JL, Ostergaard D, LeBlanc V, Ottesen B, Konge L, Dieckmann P, Van der Vleuten C. Design of simulation-based medical education and advantages and disadvantages of in situ simulation versus off-site simulation. BMC Med Educ. 2017 Jan 21;17(1):20. doi: 10.1186/s12909-016-0838-3.
- Ullman E, Kennedy M, Di Delupis FD, Pisanelli P, Burbui AG, Cussen M, Galli L, Pini R, Gensini GF. The Tuscan Mobile Simulation Program: a description of a program for the delivery of in situ simulation training. Intern Emerg Med. 2016 Sep;11(6):837-41. doi: 10.1007/s11739-016-1401-2. Epub 2016 Feb 9.
- Haji FA, Rojas D, Childs R, de Ribaupierre S, Dubrowski A. Measuring cognitive load: performance, mental effort and simulation task complexity. Med Educ. 2015 Aug;49(8):815-27. doi: 10.1111/medu.12773.
- Rosen MA, Hunt EA, Pronovost PJ, Federowicz MA, Weaver SJ. In situ simulation in continuing education for the health care professions: a systematic review. J Contin Educ Health Prof. 2012 Fall;32(4):243-54. doi: 10.1002/chp.21152.
- Petrosoniak A, Auerbach M, Wong AH, Hicks CM. In situ simulation in emergency medicine: Moving beyond the simulation lab. Emerg Med Australas. 2017 Feb;29(1):83-88. doi: 10.1111/1742-6723.12705. Epub 2016 Oct 17.
- Naismith LM, Cheung JJ, Ringsted C, Cavalcanti RB. Limitations of subjective cognitive load measures in simulation-based procedural training. Med Educ. 2015 Aug;49(8):805-14. doi: 10.1111/medu.12732.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2018
Primary Completion (Anticipated)
May 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
March 26, 2018
First Submitted That Met QC Criteria
April 8, 2018
First Posted (Actual)
April 17, 2018
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUNChrystal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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