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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02030873
Other study ID # H-4-2014-FSP-2
Secondary ID
Status Completed
Phase N/A
First received January 2, 2014
Last updated May 4, 2015
Start date January 2014
Est. completion date January 2015

Study information

Verified date May 2015
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: National Board of Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Resident in otorhinolaryngology postgraduate year 2-5

- Informed written consent

Exclusion Criteria:

- Previous participation in formal mastoidectomy training in a virtual simulator

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)


Intervention

Other:
Virtual simulation training
Virtual simulation training in the Visible Ear Simulator.

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Final Product Assessment Score Mastoidectomy final product assessment score using a modified Welling Scale for performance assessment 3 hours No
Secondary Change in simulator metrics Integrated simulator metrics including volume drilled (inside+outside target volumes), collisions with vital structures in simulation and time. 3 hours No
Secondary Change in reaction time Reaction time to a visual or auditory cue (in ms) 3 hours No
Secondary Simulation experience Background data from a questionnaire including questions on prior simulation training and experience At recruitment No
Secondary Demographics Background data from a questionnaire on participant demographics. At recruitment No
Secondary Computer skills Background data from a questionnaire on experience and interests in computers and IT At recruitment No
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