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OpenTrials
Completed

NCT Number: NCT02030873

The Effect of Virtual Simulation Training in Mastoidectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, DK-2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Resident in otorhinolaryngology postgraduate year 2-5
  • Informed written consent

Exclusion criteria

  • Previous participation in formal mastoidectomy training in a virtual simulator

Treatment and study plan

Virtual simulation training

Other

Virtual simulation training in the Visible Ear Simulator.

Primary outcomes

  1. Change in Final Product Assessment Score

    Time frame: 3 hours

    Mastoidectomy final product assessment score using a modified Welling Scale for performance assessment

Secondary outcomes

  1. Change in simulator metrics

    Time frame: 3 hours

    Integrated simulator metrics including volume drilled (inside+outside target volumes), collisions with vital structures in simulation and time.

  2. Change in reaction time

    Time frame: 3 hours

    Reaction time to a visual or auditory cue (in ms)

  3. Simulation experience

    Time frame: At recruitment

    Background data from a questionnaire including questions on prior simulation training and experience

  4. Demographics

    Time frame: At recruitment

    Background data from a questionnaire on participant demographics.

  5. Computer skills

    Time frame: At recruitment

    Background data from a questionnaire on experience and interests in computers and IT

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

The Effect of Virtual Simulation Training With the Visible Ear Simulator on Mastoidectomy Performance of Otorhinolaryngology Trainees

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2014
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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