Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy

Students Clinical Trial

Official title:

Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966185
• Other study ID #: H-4-2013-FSP-088
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: May 4, 2015
• Start date: October 2013
• Est. completion date: November 2014

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• medical students

• informed written consent

Exclusion Criteria:

• prior training on the Visible Ear Simulator

Study Design

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

Related Conditions & MeSH terms

• Clinical Skills
• Motor Skills
• Students
• Temporal Bone
• User-Computer Interface

Intervention

Other:
• Tutor function on
The simulator-integrated tutor function with volumetric green lighting of the intended volume to be drilled.

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
Other	Background data	Background data from a questionnaire including questions on demographics, prior simulation training and experience and interests in computers and IT	At recruitment	No
Primary	Change in Final Product Assessment Score	Mastoidectomy final product assessment score using a modified Welling Scale for performance assessment.	4 months	No
Secondary	Change in simulator metrics	Integrated simulator metrics on volume drilled (inside+outside target volumes), collisions with vital structures in simulation, time.	4 months	No
Secondary	Change in reaction time	Reaction time to a visual cue (in ms)	4 months	No