NCT02030873

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

January 2, 2014

Last Update Submit

May 4, 2015

Conditions

Medical EducationUser-Computer InterfaceClinical SkillsMotor SkillsTemporal Bone

Keywords

virtual simulationtemporal bonesurgical trainingmedical educationself-directed learningfinal product assessmentcognitive loadreaction timeskills trainingsimulator metrics

Outcome Measures

Primary Outcomes (1)

  • Change in Final Product Assessment Score

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

    3 hours

Secondary Outcomes (5)

  • Change in simulator metrics

    3 hours

  • Change in reaction time

    3 hours

  • Simulation experience

    At recruitment

  • Demographics

    At recruitment

  • Computer skills

    At recruitment

Study Arms (2)

Virtual simulation training first

EXPERIMENTAL

Participants in this arm receive virtual simulation training before dissection training.

Other: Virtual simulation training

Dissection training first

NO INTERVENTION

Participants in this arm receive dissection training first and then virtual simulation training.

Interventions

Virtual simulation trainingOTHER

Virtual simulation training in the Visible Ear Simulator.

Virtual simulation training first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous participation in formal mastoidectomy training in a virtual simulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Study Officials

  • Steven AW Andersen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 9, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

DK(1)