Laparoscopy SkillsEarly Phase 1NCT01483677
Comparison Study of the Nintendo Wii Versus Playstation2 in Enhancing Laparoscopic Skills
A Early Phase 1 study testing Nintendo Wii and Playstation 2 in people with Laparoscopy Skills, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
The investigators believe that subjects who practice on the Nintendo Wii will improve their laparoscopic skills more than those who practice on the Playstation2. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopy Skills
- What is being tested?
- Nintendo Wii and Playstation 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2011
- Phase
- Early Phase 1
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical Student, Resident or Attending physician at the Beth Israel Medical center.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center of The Albert Einstein College of Medicine
New York, New York, 10003
About this study
Official title: Is Nintendo Wii a More Suitable Video Game Platform Than Playstation 2 for Enhancing Laparoscopic Skills?
The investigators believe that subjects who practice on the Nintendo Wii will improve their laparoscopic skills more than those who practice on the Playstation2.
Read the detailed description
Video game experience, whether past or current, have correlated with better laparoscopy skills. Those studies were conducted using traditional game controllers. The relatively new Nintendo Wii uses a novel set of mechanics which allows for more realistic representation of player generated movements. We aim to study if the unique mechanics of the Wii can improve laparoscopy skills better than a traditional video game (Playstation 2).
- Conditions
- Laparoscopy Skills
- Being tested
- Nintendo Wii, Playstation 2
- Keywords
- Laparoscopy, video games, Nintendo Wii, Playstation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo WiiOther
Also called Boomblox
Subjects played the game Boomblox for 30 continuous minutes on the Nintendo Wii.
Playstation 2Other
Also called Time Crisis
Subjects played the game Time Crisis2 on the Playstation2 for 30 continuous minutes.
| Study group | Role | What they receive |
|---|---|---|
| Nintendo Wii | Experimental | Subjects in this arm of the study play a game (Boomblox) on the Nintendo Wii for 30 minutes. Receives: Other: Nintendo Wii |
| Playstation2 | Active comparator | Subjects in this arm of the study play a game (Time Crisis 2) on the Playstation 2 for 30 minutes. Receives: Other: Playstation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the change in box trainer scores between the Wii and Playstation2 groups.
After completion of the pretest, subjects are given a 10 minute break, 30 minutes of video game play, a 10 minute break, and 10 minutes to complete the post test.
Measured: 60 minutes
Secondary outcomes (2)
Change between pretest and post test scores in the Wii group.
After completion of the pretest, subjects are given a 10 minute break, 30 minutes of video game play, a 10 minute break, and 10 minutes to complete the post test.
Measured: 60 minutes.
Change between pretest and posttest scores for the Playstation2 group
After completion of the pretest, subjects are given a 10 minute break, 30 minutes of video game play, a 10 minute break, and 10 minutes to complete the post test.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Laparoscopy SkillsStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rujin Ju, M.D., Principal investigator, Beth Israel Medical CenterKaren C Wang, M.D., Study chair, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483677
- Sponsor's protocol ID
- 023-10
- Status last verified
- Nov 2011
- First submitted
- 30 Nov 2011
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Derossis AM, Bothwell J, Sigman HH, Fried GM. The effect of practice on performance in a laparoscopic simulator. Surg Endosc. 1998 Sep;12(9):1117-20. doi: 10.1007/s004649900796.
PubMed 9716763Rosser JC Jr, Lynch PJ, Cuddihy L, Gentile DA, Klonsky J, Merrell R. The impact of video games on training surgeons in the 21st century. Arch Surg. 2007 Feb;142(2):181-6; discusssion 186. doi: 10.1001/archsurg.142.2.181.
PubMed 17309970Smith CD, Farrell TM, McNatt SS, Metreveli RE. Assessing laparoscopic manipulative skills. Am J Surg. 2001 Jun;181(6):547-50. doi: 10.1016/s0002-9610(01)00639-0.
PubMed 11513783Lewis TM, Aggarwal R, Rajaretnam N, Grantcharov TP, Darzi A. Training in surgical oncology - the role of VR simulation. Surg Oncol. 2011 Sep;20(3):134-9. doi: 10.1016/j.suronc.2011.04.005. Epub 2011 May 24.
PubMed 21605972Munz Y, Kumar BD, Moorthy K, Bann S, Darzi A. Laparoscopic virtual reality and box trainers: is one superior to the other? Surg Endosc. 2004 Mar;18(3):485-94. doi: 10.1007/s00464-003-9043-7. Epub 2004 Feb 2.
PubMed 14752633
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Nintendo Wii a More Suitable Video Game Platform Than Playstation 2 for Enhancing Laparoscopic Skills?
- ClinicalTrials.gov ID
- NCT01483677
- Acronym / sponsor ID
- 023-10
- Conditions
- Laparoscopy Skills
- Keywords
- Laparoscopy, video games, Nintendo Wii, Playstation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 1 Dec 2011 (estimated)
- 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.
The investigators believe that subjects who practice on the Nintendo Wii will improve their laparoscopic skills more than those who practice on the Playstation2.
Detailed description
Video game experience, whether past or current, have correlated with better laparoscopy skills. Those studies were conducted using traditional game controllers. The relatively new Nintendo Wii uses a novel set of mechanics which allows for more realistic representation of player generated movements. We aim to study if the unique mechanics of the Wii can improve laparoscopy skills better than a traditional video game (Playstation 2).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintendo Wii | Experimental | Other: Nintendo WiiSubjects in this arm of the study play a game (Boomblox) on the Nintendo Wii for 30 minutes. |
| Playstation2 | Active comparator | Other: Playstation 2Subjects in this arm of the study play a game (Time Crisis 2) on the Playstation 2 for 30 minutes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical Student, Resident or Attending physician at the Beth Israel Medical center.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Nintendo WiiAlso: BoombloxSubjects played the game Boomblox for 30 continuous minutes on the Nintendo Wii. | Other | Nintendo Wii |
| Playstation 2Also: Time CrisisSubjects played the game Time Crisis2 on the Playstation2 for 30 continuous minutes. | Other | Playstation2 |
Primary outcome
Difference in the change in box trainer scores between the Wii and Playstation2 groups.
Time frame: 60 minutes
After completion of the pretest, subjects are given a 10 minute break, 30 minutes of video game play, a 10 minute break, and 10 minutes to complete the post test.
2 secondary outcomes
Change between pretest and post test scores in the Wii group.
Time frame: 60 minutes.
Change between pretest and posttest scores for the Playstation2 group
Time frame: 60 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 1 Dec 2011.
- Background: PubMed 9716763Derossis AM, Bothwell J, Sigman HH, Fried GM. The effect of practice on performance in a laparoscopic simulator. Surg Endosc. 1998 Sep;12(9):1117-20. doi: 10.1007/s004649900796.
- Background: PubMed 17309970Rosser JC Jr, Lynch PJ, Cuddihy L, Gentile DA, Klonsky J, Merrell R. The impact of video games on training surgeons in the 21st century. Arch Surg. 2007 Feb;142(2):181-6; discusssion 186. doi: 10.1001/archsurg.142.2.181.
- Background: PubMed 11513783Smith CD, Farrell TM, McNatt SS, Metreveli RE. Assessing laparoscopic manipulative skills. Am J Surg. 2001 Jun;181(6):547-50. doi: 10.1016/s0002-9610(01)00639-0.
- Background: PubMed 21605972Lewis TM, Aggarwal R, Rajaretnam N, Grantcharov TP, Darzi A. Training in surgical oncology - the role of VR simulation. Surg Oncol. 2011 Sep;20(3):134-9. doi: 10.1016/j.suronc.2011.04.005. Epub 2011 May 24.
- Background: PubMed 14752633Munz Y, Kumar BD, Moorthy K, Bann S, Darzi A. Laparoscopic virtual reality and box trainers: is one superior to the other? Surg Endosc. 2004 Mar;18(3):485-94. doi: 10.1007/s00464-003-9043-7. Epub 2004 Feb 2.
- Mechanical engineering aspect of WiiLink provided by the sponsor.
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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.
Rujin Ju, M.D. principal investigator
Beth Israel Medical Center
Karen C Wang, M.D. study chair
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nintendo Wii and Playstation 2 in people with Laparoscopy Skills, run by Beth Israel Medical Center 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 1 inclusion and 1 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 1 Dec 2011. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference in the change in box trainer scores between the Wii and Playstation2 groups. (time frame: 60 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 NCT01483677, which also lists 5 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 1 Dec 2011.