Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04334486
Other study ID # 19-0110
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2020
Est. completion date July 15, 2021

Study information

Verified date August 2021
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will examine the history of video game use an activities of manual dexterity with the scored skills used in the Eyesi surgical simulator. Subjects will be asked to participate in video games or no video games prior to testing skills in Eyesi to examine training effects of video game participation and changes in manual dexterity.


Description:

A popular crossover fighting video game released in 2001 for the Nintendo Gamecube that emphasizes reflexes and dexterity to perform specific maneuvers will be used in this study as a potential dexterity trainer. The Eyesi is a training device utilized in many ophthalmology residency training programs to improve intraocular operative skills. The EyeSi is a validated training tool that uses high-end virtual reality that can be equipped with instrumentation for cataract or vitreoretinal surgery. The device itself consists of eyepieces that replicate a surgical scope, a mannequin head where handpiece probes can be inserted and position tracked to virtually recreate a surgical environment. The simulator also has a monitor that can be used to see the surgical simulator environment. As part of the software, numerous training tasks and exercises are available programmed into the device. These exercises utilize numerous metrics such as distance traveled, tissue treatment, efficiency, instrument handing, and others to provide the user with a raw score out of 100 for each task. Subjects will then be asked to complete a manual dexterity questionnaire including history of video game use as well as tasks demonstrating manual dexterity ability such as the ability to play a musical instrument. Participants will then be randomized to the intervention group or the control group. The intervention group will be asked to play 10 minutes of the Gamecube game "Super Smash Brothers Melee" as their "warm-up" prior to completing the EyeSi surgical tasks of navigation, forceps, and bimanual with their scores collected and averaged across all tasks. The control group will complete the EyeSi surgical tasks of navigation, forceps, and bimanual with their scores collected and averaged, but will not perform a "warm-up" task. Planned statistical analysis will include an average of total scores across navigation, forceps, and bimanual tasks. Chi square analysis will then be utilized to determine any statistical significance between intervention and control groups. Simulator scores will also be associated with questionnaire responses and simple linear regression will be used for analysis.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 15, 2021
Est. primary completion date July 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - UTMB Medical student volunteers who respond to email invitation to participate - 18-40 years of age inclusive Exclusion Criteria: - Prior experience with EyeSi surgical simulator - Not a UTMB Medical Student - Not between 18-40 years of age inclusive

Study Design


Related Conditions & MeSH terms

  • High Fidelity Simulation Training

Intervention

Other:
Super Smash Brothers Melee (Gamecube)
10 minutes of participation in Super Smash Brothers Melee prior to Eyesi Surgical Simulator evaluation of skills.

Locations

Country Name City State
United States University of Texas Medical Branch, Ophthalmology Clinical Research Center Galveston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (11)

Adams BJ, Margaron F, Kaplan BJ. Comparing video games and laparoscopic simulators in the development of laparoscopic skills in surgical residents. J Surg Educ. 2012 Nov-Dec;69(6):714-7. doi: 10.1016/j.jsurg.2012.06.006. — View Citation

Bergqvist J, Person A, Vestergaard A, Grauslund J. Establishment of a validated training programme on the Eyesi cataract simulator. A prospective randomized study. Acta Ophthalmol. 2014 Nov;92(7):629-34. doi: 10.1111/aos.12383. Epub 2014 Mar 11. — View Citation

Crochet P, Aggarwal R, Dubb SS, Ziprin P, Rajaretnam N, Grantcharov T, Ericsson KA, Darzi A. Deliberate practice on a virtual reality laparoscopic simulator enhances the quality of surgical technical skills. Ann Surg. 2011 Jun;253(6):1216-22. doi: 10.1097/SLA.0b013e3182197016. — View Citation

Daly MK, Gonzalez E, Siracuse-Lee D, Legutko PA. Efficacy of surgical simulator training versus traditional wet-lab training on operating room performance of ophthalmology residents during the capsulorhexis in cataract surgery. J Cataract Refract Surg. 2013 Nov;39(11):1734-41. doi: 10.1016/j.jcrs.2013.05.044. — View Citation

McCannel CA, Reed DC, Goldman DR. Ophthalmic surgery simulator training improves resident performance of capsulorhexis in the operating room. Ophthalmology. 2013 Dec;120(12):2456-2461. doi: 10.1016/j.ophtha.2013.05.003. Epub 2013 Jun 21. — View Citation

Middleton KK, Hamilton T, Tsai PC, Middleton DB, Falcone JL, Hamad G. Improved nondominant hand performance on a laparoscopic virtual reality simulator after playing the Nintendo Wii. Surg Endosc. 2013 Nov;27(11):4224-31. doi: 10.1007/s00464-013-3027-z. Epub 2013 Jun 13. — View Citation

Pokroy R, Du E, Alzaga A, Khodadadeh S, Steen D, Bachynski B, Edwards P. Impact of simulator training on resident cataract surgery. Graefes Arch Clin Exp Ophthalmol. 2013 Mar;251(3):777-81. doi: 10.1007/s00417-012-2160-z. Epub 2012 Sep 25. — View Citation

Seymour NE, Gallagher AG, Roman SA, O'Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002 Oct;236(4):458-63; discussion 463-4. — View Citation

Solverson DJ, Mazzoli RA, Raymond WR, Nelson ML, Hansen EA, Torres MF, Bhandari A, Hartranft CD. Virtual reality simulation in acquiring and differentiating basic ophthalmic microsurgical skills. Simul Healthc. 2009 Summer;4(2):98-103. doi: 10.1097/SIH.0b013e318195419e. — View Citation

Thomsen AS, Bach-Holm D, Kjærbo H, Højgaard-Olsen K, Subhi Y, Saleh GM, Park YS, la Cour M, Konge L. Operating Room Performance Improves after Proficiency-Based Virtual Reality Cataract Surgery Training. Ophthalmology. 2017 Apr;124(4):524-531. doi: 10.1016/j.ophtha.2016.11.015. Epub 2016 Dec 22. — View Citation

Thomsen AS, Kiilgaard JF, Kjaerbo H, la Cour M, Konge L. Simulation-based certification for cataract surgery. Acta Ophthalmol. 2015 Aug;93(5):416-21. doi: 10.1111/aos.12691. Epub 2015 Feb 26. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Video Game training effect on Eyesi Surgical Simulator Scores Planned statistical analysis will include an average of total scores across navigation, forceps, and bimanual tasks. Chi square analysis will then be utilized to determine any statistical significance between intervention and control groups. 30 minutes
Secondary Training effect of manual dexterity activities on Eyesi Surgical Simulator Scores as reported in questionnaire. Subjects will then be asked to complete a manual dexterity questionnaire including history of video game use as well as tasks demonstrating manual dexterity ability such as the ability to play a musical instrument. Simulator scores will be associated with questionnaire responses and simple linear regression will be used for analysis. 30 minutes
See also
  Status Clinical Trial Phase
Recruiting NCT03307421 - Team Debriefing With Instructor vs Team Debriefing Without Instructor After Simulating a Vital Emergency in a Multidisciplinary Team N/A
Completed NCT06144658 - VR-MARS Virtual Reality, Medical Assistance and Rescue for Space N/A
Completed NCT05672446 - Evaluation of the Effect of Standardized Child Patient Use on Preparing the Child for Process Skill; A Mix Method Study N/A
Completed NCT04715724 - Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment N/A
Recruiting NCT05904314 - Evaluation of the Effectiveness of Teaching Method With Simulation in Electronic Fetal Monitoring Management N/A
Not yet recruiting NCT05493774 - Preliminary Exploration of Applying Multi-person Simulation Training to Improve Nurse-led Burn and Scald Nursing Care N/A
Completed NCT04381572 - The Impact of High Fidelity Simulation on Stress Level in Medical Students.