Working... Menu

Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01966185
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
Steven Andersen, Rigshospitalet, Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
User-Computer Interface Clinical Skills Motor Skills Temporal Bone Students Other: Tutor function on Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy
Study Start Date : October 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
No Intervention: Tutor function off
The tutor function will be off for 12 out of 12 repeat simulations.
Experimental: Tutor function on
The group will have the tutor function on for the 5 first out of 12 repeat simulation sessions.
Other: Tutor function on
The simulator-integrated tutor function with volumetric green lighting of the intended volume to be drilled.

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • medical students
  • informed written consent

Exclusion Criteria:

  • prior training on the Visible Ear Simulator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01966185

Layout table for location information
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Layout table for investigator information
Principal Investigator: Steven AW Andersen, MD Rigshospitalet, Denmark

Layout table for additonal information
Responsible Party: Steven Andersen, Research fellow, MD, Rigshospitalet, Denmark Identifier: NCT01966185     History of Changes
Other Study ID Numbers: H-4-2013-FSP-088
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Steven Andersen, Rigshospitalet, Denmark:
virtual simulation
temporal bone
surgical training
medical education
self-directed learning
final product assessment
cognitive load
reaction time
skills training
simulator metrics