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Teaching Medical Students How to Suture: Standard Simulation vs in Situ

Primary Purpose

Sutured Laceration, Laceration

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Simulated Learning Environment
Sponsored by
Memorial University of Newfoundland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sutured Laceration focused on measuring Simulation, Medical Students, In Situ Simulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Simulation Lab

    ER in situ Simulation

    Arm Description

    Outcomes

    Primary Outcome Measures

    How each simulated learning environment effects a student's ability to learn how to suture
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 26, 2018
    Last Updated
    March 11, 2019
    Sponsor
    Memorial University of Newfoundland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03499002
    Brief Title
    Teaching Medical Students How to Suture: Standard Simulation vs in Situ
    Official Title
    Teaching Medical Students How to Suture: Standard Simulation vs in Situ
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    study was discontinued
    Study Start Date
    April 2018 (Anticipated)
    Primary Completion Date
    May 2018 (Anticipated)
    Study Completion Date
    June 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Memorial University of Newfoundland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sutured Laceration, Laceration
    Keywords
    Simulation, Medical Students, In Situ Simulation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    Research assistant will be present when student randomly chooses which environment they will learn how to suture in. The principal investigator will be unaware of this randomization.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Simulation Lab
    Arm Type
    Experimental
    Arm Title
    ER in situ Simulation
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Simulated Learning Environment
    Other Intervention Name(s)
    Simulation lab, ER in situ simulation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    How each simulated learning environment effects a student's ability to learn how to suture
    Description
    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.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chrystal Horwood, MD
    Organizational Affiliation
    Memorial University of Newfoundland and Labrador
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28562455
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28984729
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28109296
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    26861702
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    26152493
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    23280527
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27748042
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    26152492
    Citation
    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.
    Results Reference
    result

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    Teaching Medical Students How to Suture: Standard Simulation vs in Situ

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