User-Computer InterfaceNCT01966185
Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy
A study testing Tutor function on in people with User-Computer Interface and Clinical Skills, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to establish learning curves of mastoidectomy training in virtual surgical simulation training, to establish the long-term effect of repeat simulation training and to explore the transfer of skills, the roles of an integrated tutor function, self-directed learning and cognitive load. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- User-Computer Interface, Clinical Skills, Motor Skills
- What is being tested?
- Tutor function on
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Nov 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medical students
- informed written consent
Who cannot join
- prior training on the Visible Ear Simulator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish learning curves of mastoidectomy training in virtual surgical simulation training, to establish the long-term effect of repeat simulation training and to explore the transfer of skills, the roles of an integrated tutor function, self-directed learning and cognitive load.
Read the detailed description
Repeat surgical simulation training is known to provide better learning and long-term transfer. The learning curves for the mastoidectomy procedure have not been intensively studied. The only study conducted on learning curves in mastoidectomy to date found a plateau in performance for 4 medical students after about 4 mastoidectomy procedures on separate occasions. The participants were however assessed using an unvalidated, unestablished simulator integrated overall performance score. There is therefore a need for establishing learning curves and plateau using established objective assessment scales, which could have implications for future studies and on a larger scale for the future organization of temporal bone dissection courses.
The long-term effect on learning of deliberate repeat simulator training of the mastoidectomy procedure has not previously been studied. The role of cognitive load in learning complex surgical technical skills in simulation has not been studied in great detail. The relationship between time and progress/performance assessment using Final Product Analysis (FPA) has not been studied.
We have previously suggested that a tutor-function with volumetric approach with green lighting of the procedural steps could have an effect on performance. The effect of the tutor function could however not be isolated.
- Conditions
- User-Computer Interface, Clinical Skills, Motor Skills, Temporal Bone, Students
- Being tested
- Tutor function on
- Keywords
- virtual simulation, temporal bone, surgical training, medical education, self-directed learning, final product assessment, cognitive load, reaction time, skills training, simulator metrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tutor function onOther
The simulator-integrated tutor function with volumetric green lighting of the intended volume to be drilled.
| Study group | Role | What they receive |
|---|---|---|
| Tutor function off | No intervention | The tutor function will be off for 12 out of 12 repeat simulations. |
| Tutor function on | Experimental | The group will have the tutor function on for the 5 first out of 12 repeat simulation sessions. Receives: Other: Tutor function on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Final Product Assessment Score
Mastoidectomy final product assessment score using a modified Welling Scale for performance assessment.
Measured: 4 months
Secondary outcomes (2)
Change in simulator metrics
Integrated simulator metrics on volume drilled (inside+outside target volumes), collisions with vital structures in simulation, time.
Measured: 4 months
Change in reaction time
Reaction time to a visual cue (in ms)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for User-Computer InterfaceStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Andersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Steven AW Andersen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966185
- Sponsor's protocol ID
- H-4-2013-FSP-088
- Status last verified
- May 2015
- First submitted
- 11 Oct 2013
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy
- ClinicalTrials.gov ID
- NCT01966185
- Acronym / sponsor ID
- H-4-2013-FSP-088
- Conditions
- User-Computer Interface, Clinical Skills, Motor Skills, Temporal Bone, Students
- Keywords
- virtual simulation, temporal bone, surgical training, medical education, self-directed learning, final product assessment, cognitive load, reaction time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Oct 2013 (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 purpose of this study is to establish learning curves of mastoidectomy training in virtual surgical simulation training, to establish the long-term effect of repeat simulation training and to explore the transfer of skills, the roles of an integrated tutor function, self-directed learning and cognitive load.
Detailed description
Repeat surgical simulation training is known to provide better learning and long-term transfer. The learning curves for the mastoidectomy procedure have not been intensively studied. The only study conducted on learning curves in mastoidectomy to date found a plateau in performance for 4 medical students after about 4 mastoidectomy procedures on separate occasions. The participants were however assessed using an unvalidated, unestablished simulator integrated overall performance score. There is therefore a need for establishing learning curves and plateau using established objective assessment scales, which could have implications for future studies and on a larger scale for the future organization of temporal bone dissection courses.
The long-term effect on learning of deliberate repeat simulator training of the mastoidectomy procedure has not previously been studied. The role of cognitive load in learning complex surgical technical skills in simulation has not been studied in great detail. The relationship between time and progress/performance assessment using Final Product Analysis (FPA) has not been studied.
We have previously suggested that a tutor-function with volumetric approach with green lighting of the procedural steps could have an effect on performance. The effect of the tutor function could however not be isolated.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tutor function off | No intervention | –The tutor function will be off for 12 out of 12 repeat simulations. |
| Tutor function on | Experimental | Other: Tutor function onThe group will have the tutor function on for the 5 first out of 12 repeat simulation sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- medical students
- informed written consent
Key exclusion criteria (1 listed)
- prior training on the Visible Ear Simulator
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 |
|---|---|---|
| Tutor function onThe simulator-integrated tutor function with volumetric green lighting of the intended volume to be drilled. | Other | Tutor function on |
Primary outcome
Change in Final Product Assessment Score
Time frame: 4 months
Mastoidectomy final product assessment score using a modified Welling Scale for performance assessment.
2 secondary outcomes
Change in simulator metrics
Time frame: 4 months
Change in reaction time
Time frame: 4 months
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 5 May 2015.
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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.
Steven AW Andersen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tutor function on in people with User-Computer Interface and Clinical Skills, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 May 2015. 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 Denmark. 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?
Change in Final Product Assessment Score (time frame: 4 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 5 May 2015.