NCT01966185

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

October 11, 2013

Last Update Submit

May 4, 2015

Conditions

User-Computer InterfaceClinical SkillsMotor SkillsTemporal BoneStudents

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.

    4 months

Secondary Outcomes (2)

  • Change in simulator metrics

    4 months

  • Change in reaction time

    4 months

Other Outcomes (1)

  • Background data

    At recruitment

Study Arms (2)

Tutor function off

NO INTERVENTION

The tutor function will be off for 12 out of 12 repeat simulations.

Tutor function on

EXPERIMENTAL

The group will have the tutor function on for the 5 first out of 12 repeat simulation sessions.

Other: Tutor function on

Interventions

Tutor function onOTHER

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

Tutor function on

Eligibility Criteria

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

You may qualify if:

  • medical students
  • informed written consent

You may not qualify if:

  • prior training on the Visible Ear 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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow, MD

Study Record Dates

First Submitted

October 11, 2013

First Posted

October 21, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

DK(1)