EducationNCT01753947
Individualized Deliberate Practice on a Virtual Reality Simulator
A study testing Deliberate Practice in people with Education and General Surgery, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Training on simulated models in a surgical skills laboratory has been shown to improve technical performance in the operating room. Currently described simulation-based curricula consist of trainees practicing the same tasks until expert proficiency is reached. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, General Surgery
- What is being tested?
- Deliberate Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Jan 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- post graduate year 1 and 2 surgical residents
- performed less than 10 laparoscopic cholecystectomies as the primary surgeon
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Deliberate Practice on a Virtual Reality Simulator Improves Technical Performance of Surgical Novices in the Operating Room: A Randomized Controlled Trial
Training on simulated models in a surgical skills laboratory has been shown to improve technical performance in the operating room. Currently described simulation-based curricula consist of trainees practicing the same tasks until expert proficiency is reached. It has yet to be investigated whether individualized deliberate practice, where curricula tasks vary depending on prior levels of technical proficiency, would translate to the operating room.
This randomized controlled trial effectively demonstrates that deliberate practice on a virtual reality simulator results in an improvement in technical skills in a real clinical situation. This enhances the feasibility of implementing simulation-based curricula into residency training programs, and consequently has the potential to improve patient safety.
- Conditions
- Education, General Surgery
- Being tested
- Deliberate Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deliberate PracticeOther
| Study group | Role | What they receive |
|---|---|---|
| Deliberate Practice | Experimental | Residents in the deliberate practice group received individualized feedback at the end of the initial assessment case. The staff surgeon supervising the case completed 3 previously validated technical skills assessment forms. Receives: Other: Deliberate Practice |
| Conventional Feedback | No intervention | Residents in the control group received informal feedback as they performed the initial laparoscopic cholecystectomy in the operating room. This was left up to the discretion of the staff surgeon supervising the operation. This corresponds to the routine teaching and feedback practices that occur during conventional surgical residency training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical skills
Participants' technical skills will be assessed in the operating room as they perform a laparoscopic cholecystectomy under supervision. The procedure will be video-recorded and sent for assessment to a blinded evaluator. Technical skills will be assessed using a previously validated technical skills assessment tool (Objective Structured Assessment of Technical Skill - OSATS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies 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
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Physicians and Surgeons of Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753947
- Sponsor's protocol ID
- Deliberate Practice
- Status last verified
- Dec 2012
- First submitted
- 7 Dec 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Deliberate Practice on a Virtual Reality Simulator Improves Technical Performance of Surgical Novices in the Operating Room: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01753947
- Acronym / sponsor ID
- Deliberate Practice
- Conditions
- Education, General Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Royal College of Physicians and Surgeons of Canada
- Study start
- Jan 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Dec 2012 (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.
Training on simulated models in a surgical skills laboratory has been shown to improve technical performance in the operating room. Currently described simulation-based curricula consist of trainees practicing the same tasks until expert proficiency is reached. It has yet to be investigated whether individualized deliberate practice, where curricula tasks vary depending on prior levels of technical proficiency, would translate to the operating room.
This randomized controlled trial effectively demonstrates that deliberate practice on a virtual reality simulator results in an improvement in technical skills in a real clinical situation. This enhances the feasibility of implementing simulation-based curricula into residency training programs, and consequently has the potential to improve patient safety.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deliberate Practice | Experimental | Other: Deliberate PracticeResidents in the deliberate practice group received individualized feedback at the end of the initial assessment case. The staff surgeon supervising the case completed 3 previously validated technical skills assessment forms. |
| Conventional Feedback | No intervention | –Residents in the control group received informal feedback as they performed the initial laparoscopic cholecystectomy in the operating room. This was left up to the discretion of the staff surgeon supervising the operation. This corresponds to the routine teaching and feedback practices that occur during conventional surgical residency training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- post graduate year 1 and 2 surgical residents
- performed less than 10 laparoscopic cholecystectomies as the primary surgeon
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| Deliberate Practice | Other | Deliberate Practice |
Primary outcome
Technical skills
Time frame: 6 months
Participants' technical skills will be assessed in the operating room as they perform a laparoscopic cholecystectomy under supervision. The procedure will be video-recorded and sent for assessment to a blinded evaluator. Technical skills will be assessed using a previously validated technical skills assessment tool (Objective Structured Assessment of Technical Skill - OSATS)
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 20 Dec 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deliberate Practice in people with Education and General Surgery, run by Unity Health Toronto at 1 site in Canada.
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 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 20 Dec 2012. 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 Canada. 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?
Technical skills (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2012; AzTrials last refreshed its copy on 29 Oct 2026.