High Fidelity Simulation TrainingNCT04334486
The Effects of Video Game Warm-up on EyeSi Surgical Simulator Performance
A study testing Super Smash Brothers Melee (Gamecube) in people with High Fidelity Simulation Training, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- High Fidelity Simulation Training
- What is being tested?
- Super Smash Brothers Melee (Gamecube)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- UTMB Medical student volunteers who respond to email invitation to participate
- 18-40 years of age inclusive
Who cannot join
- Prior experience with EyeSi surgical simulator
- Not a UTMB Medical Student
- Not between 18-40 years of age inclusive
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch, Ophthalmology Clinical Research Center
Galveston, Texas, 77555-1106
About this study
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.
Read the detailed 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.
- Conditions
- High Fidelity Simulation Training
- Being tested
- Super Smash Brothers Melee (Gamecube)
- Keywords
- training effect, bimanual dexterity, surgical skills, ophthalmology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Smash Brothers Melee (Gamecube)Other
10 minutes of participation in Super Smash Brothers Melee prior to Eyesi Surgical Simulator evaluation of skills.
| Study group | Role | What they receive |
|---|---|---|
| Video Game Trained | Experimental | Subjects will participate in video gaming for 10 minutes prior to Eyesi simulator test of surgical skills. Receives: Other: Super Smash Brothers Melee (Gamecube) |
| No Video Game Training | No intervention | No video gaming will occur for warm up to Eyesi simulator test of surgical skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start17 Sep 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for High Fidelity Simulation TrainingStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded parallel examination of training or non-training effect of video game participation prior to Eyesi surgical simulator evaluation.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praveena Gupta, M.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334486
- Sponsor's protocol ID
- 19-0110
- Status last verified
- Aug 2021
- First submitted
- 1 Apr 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be assigned a unique participant identification number and no personal information will be collected as part of the data set. Information from the questionnaire and study tasks will be associated with your subject identification number not any personal identifiers. Your participation or lack of participation will not be made known to any individuals outside of the study personnel with which you interface and will also be unavailable to any faculty within the UTMB Ophthalmology program to ensure that there is no risk in participation affecting future departmental relationships, evaluations or considerations.
Publications
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.
PubMed 21516035McCannel 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.
PubMed 23796766Pokroy 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.
PubMed 23007233Seymour 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. doi: 10.1097/00000658-200210000-00008.
PubMed 12368674Thomsen ASS, Kiilgaard JF, Kjaerbo H, la Cour M, Konge L. Simulation-based certification for cataract surgery. Acta Ophthalmol. 2015 Aug;93(5):416-421. doi: 10.1111/aos.12691. Epub 2015 Feb 26.
PubMed 25722080Bergqvist 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.
PubMed 24612448Solverson 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.
PubMed 19444047Thomsen AS, Bach-Holm D, Kjaerbo H, Hojgaard-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.
PubMed 28017423Daly 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.
PubMed 24160383Adams 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.
PubMed 23111035Middleton 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.
PubMed 23760943
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Video Game Warm-up on EyeSi Surgical Simulator Performance
- ClinicalTrials.gov ID
- NCT04334486
- Acronym / sponsor ID
- 19-0110
- Conditions
- High Fidelity Simulation Training
- Keywords
- training effect, bimanual dexterity, surgical skills, ophthalmology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded parallel examination of training or non-training effect of video game participation prior to Eyesi surgical simulator evaluation.
| Arm | Type | Receives |
|---|---|---|
| Video Game Trained | Experimental | Other: Super Smash Brothers Melee (Gamecube)Subjects will participate in video gaming for 10 minutes prior to Eyesi simulator test of surgical skills. |
| No Video Game Training | No intervention | –No video gaming will occur for warm up to Eyesi simulator test of surgical skills |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- UTMB Medical student volunteers who respond to email invitation to participate
- 18-40 years of age inclusive
Key exclusion criteria (3 listed)
- Prior experience with EyeSi surgical simulator
- Not a UTMB Medical Student
- Not between 18-40 years of age inclusive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super Smash Brothers Melee (Gamecube)10 minutes of participation in Super Smash Brothers Melee prior to Eyesi Surgical Simulator evaluation of skills. | Other | Video Game Trained |
Primary outcome
Video Game training effect on Eyesi Surgical Simulator Scores
Time frame: 30 minutes
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.
1 secondary outcome
Training effect of manual dexterity activities on Eyesi Surgical Simulator Scores as reported in questionnaire.
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Background: PubMed 21516035Crochet 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.
- Background: PubMed 23796766McCannel 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.
- Background: PubMed 23007233Pokroy 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.
- Background: PubMed 12368674Seymour 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. doi: 10.1097/00000658-200210000-00008.
- Background: PubMed 25722080Thomsen ASS, Kiilgaard JF, Kjaerbo H, la Cour M, Konge L. Simulation-based certification for cataract surgery. Acta Ophthalmol. 2015 Aug;93(5):416-421. doi: 10.1111/aos.12691. Epub 2015 Feb 26.
- Background: PubMed 24612448Bergqvist 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.
- Background: PubMed 19444047Solverson 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.
- Background: PubMed 28017423Thomsen AS, Bach-Holm D, Kjaerbo H, Hojgaard-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.
- Background: PubMed 24160383Daly 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.
- Background: PubMed 23111035Adams 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.
- Background: PubMed 23760943Middleton 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.
- Individual participant dataSharing planned: No. Data will be assigned a unique participant identification number and no personal information will be collected as part of the data set. Information from the questionnaire and study tasks will be associated with your subject identification number not any personal identifiers. Your participation or lack of participation will not be made known to any individuals outside of the study personnel with which you interface and will also be unavailable to any faculty within the UTMB Ophthalmology program to ensure that there is no risk in participation affecting future departmental relationships, evaluations or considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveena Gupta, M.D. principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super Smash Brothers Melee (Gamecube) in people with High Fidelity Simulation Training, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video Game training effect on Eyesi Surgical Simulator Scores (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04334486, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.