Medical EducationNCT02030873
The Effect of Virtual Simulation Training in Mastoidectomy
A study testing Virtual simulation training in people with Medical Education and User-Computer Interface, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect of virtual simulation training on mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance assessment using a final-product analysis approach and to explore the role of 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
- Medical Education, User-Computer Interface, Clinical Skills
- What is being tested?
- Virtual simulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Jan 2015
- 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
- Resident in otorhinolaryngology postgraduate year 2-5
- Informed written consent
Who cannot join
- Previous participation in formal mastoidectomy training in a virtual simulator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Simulation Training With the Visible Ear Simulator on Mastoidectomy Performance of Otorhinolaryngology Trainees
The purpose of this study is to investigate the effect of virtual simulation training on mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance assessment using a final-product analysis approach and to explore the role of cognitive load.
Read the detailed description
Traditional dissection training in temporal bone surgery is not evidence-based yet gold standard. In the recent years the Visible Ear Simulator has been used as an introduction to mastoidectomy in the Danish temporal bone course curriculum before letting the participants move on to dissection training in order to maximize the yield from the dissection training. Instructors have the impression that participants perform better in dissection after the simulator training session has been introduced. Our pilot study suggests that participants perform better in the simulator compared to traditional dissection training. This could be due to a reduction of the cognitive load in the virtual simulator.
These observations lead to the hypothesis that virtual simulation training of mastoidectomy provides an effect that improves performance in traditional dissection training.
- Being tested
- Virtual simulation training
- 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.
Virtual simulation trainingOther
Virtual simulation training in the Visible Ear Simulator.
| Study group | Role | What they receive |
|---|---|---|
| Virtual simulation training first | Experimental | Participants in this arm receive virtual simulation training before dissection training. Receives: Other: Virtual simulation training |
| Dissection training first | No intervention | Participants in this arm receive dissection training first and then virtual simulation training. |
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: 3 hours
Secondary outcomes (5)
Change in simulator metrics
Integrated simulator metrics including volume drilled (inside+outside target volumes), collisions with vital structures in simulation and time.
Measured: 3 hours
Change in reaction time
Reaction time to a visual or auditory cue (in ms)
Measured: 3 hours
Simulation experience
Background data from a questionnaire including questions on prior simulation training and experience
Measured: At recruitment
Demographics
Background data from a questionnaire on participant demographics.
Measured: At recruitment
Computer skills
Background data from a questionnaire on experience and interests in computers and IT
Measured: At recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT02030873
- Sponsor's protocol ID
- H-4-2014-FSP-2
- Status last verified
- May 2015
- First submitted
- 2 Jan 2014
- 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
- The Effect of Virtual Simulation Training With the Visible Ear Simulator on Mastoidectomy Performance of Otorhinolaryngology Trainees
- ClinicalTrials.gov ID
- NCT02030873
- Acronym / sponsor ID
- H-4-2014-FSP-2
- 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
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Jan 2014 (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 investigate the effect of virtual simulation training on mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance assessment using a final-product analysis approach and to explore the role of cognitive load.
Detailed description
Traditional dissection training in temporal bone surgery is not evidence-based yet gold standard. In the recent years the Visible Ear Simulator has been used as an introduction to mastoidectomy in the Danish temporal bone course curriculum before letting the participants move on to dissection training in order to maximize the yield from the dissection training. Instructors have the impression that participants perform better in dissection after the simulator training session has been introduced. Our pilot study suggests that participants perform better in the simulator compared to traditional dissection training. This could be due to a reduction of the cognitive load in the virtual simulator.
These observations lead to the hypothesis that virtual simulation training of mastoidectomy provides an effect that improves performance in traditional dissection training.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual simulation training first | Experimental | Other: Virtual simulation trainingParticipants in this arm receive virtual simulation training before dissection training. |
| Dissection training first | No intervention | –Participants in this arm receive dissection training first and then virtual simulation training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Resident in otorhinolaryngology postgraduate year 2-5
- Informed written consent
Key exclusion criteria (1 listed)
- Previous participation in formal mastoidectomy training in a virtual 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 |
|---|---|---|
| Virtual simulation trainingVirtual simulation training in the Visible Ear Simulator. | Other | Virtual simulation training first |
Primary outcome
Change in Final Product Assessment Score
Time frame: 3 hours
Mastoidectomy final product assessment score using a modified Welling Scale for performance assessment
5 secondary outcomes
Change in simulator metrics
Time frame: 3 hours
Change in reaction time
Time frame: 3 hours
Simulation experience
Time frame: At recruitment
Demographics
Time frame: At recruitment
Computer skills
Time frame: At recruitment
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 Virtual simulation training in people with Medical Education and User-Computer Interface, 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: 3 hours). 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.