Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03499002
Other study ID # MUNChrystal
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2018
Est. completion date June 2018

Study information

Verified date April 2018
Source Memorial University of Newfoundland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2018
Est. primary completion date May 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Simulated Learning Environment
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Memorial University of Newfoundland

References & Publications (8)

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. — View 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. 2017 Oct 4. doi: 10.1097/PTS.00000000000004 — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Sørensen JL, Østergaard 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. d — View 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. d — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 week
See also
  Status Clinical Trial Phase
Terminated NCT03280628 - Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches N/A
Completed NCT00451724 - Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair Phase 2
Completed NCT05240248 - Optilene® Suture Material for Dermal Sutures
Completed NCT02882256 - Video Discharge Instructions (VDI) as Adjuncts to Written Discharge Instructions in the Emergency Department N/A
Active, not recruiting NCT02168439 - Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair Phase 4
Completed NCT03199456 - A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults N/A
Completed NCT03080467 - Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive
Recruiting NCT05225714 - Dermal Wound Closure Using Silkam®
Active, not recruiting NCT01911351 - Nitrous Oxide Use in Minor Procedures N/A
Suspended NCT01268670 - The Addition of Oral Analgesics to LET During Laceration Repair N/A
Recruiting NCT04557761 - Comparison of microMend® Devices to Sutures in Closing Lacerations in Children N/A
Completed NCT05812352 - Supporting Laypeople Addressing Prehospital Hemorrhage Study N/A
Completed NCT00834730 - Comparison of N2O Inhalation and Ketamine in Pediatric PSA Phase 4
Completed NCT03053947 - Pain Free Laceration Repairs Using Intra-nasal Ketamine Phase 2
Recruiting NCT03681717 - Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair N/A
Completed NCT03071601 - Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department Phase 4
Completed NCT06370910 - Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction N/A
Completed NCT05148390 - Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
Not yet recruiting NCT06217081 - 3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and Incisions N/A