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Completed

NCT Number: NCT01966185

Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy

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.

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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

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • medical students
  • informed written consent

Exclusion criteria

  • prior training on the Visible Ear Simulator

Treatment and study plan

Tutor function on

Other

The simulator-integrated tutor function with volumetric green lighting of the intended volume to be drilled.

Primary outcomes

  1. Change in Final Product Assessment Score

    Time frame: 4 months

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

Secondary outcomes

  1. Change in simulator metrics

    Time frame: 4 months

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

  2. Change in reaction time

    Time frame: 4 months

    Reaction time to a visual cue (in ms)

Other outcomes

  1. Background data

    Time frame: At recruitment

    Background data from a questionnaire including questions on demographics, prior simulation training and experience and interests in computers and IT

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 21, 2013
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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