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CompletedNCT02030873Updated May 5, 2015

The Effect of Virtual Simulation Training in Mastoidectomy

An interventional study of Virtual simulation training in Medical Education, User-Computer Interface and Clinical Skills, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-05.

Sponsored by Rigshospitalet, Denmark · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Traditional dissection training in temporal bone surgery is not evidence-based yet gold standard. In the recent years the Visible Ear Simulator has been used as an introduction to mastoidectomy in the Danish temporal bone course curriculum before letting the participants move on to dissection training in order to maximize the yield from the dissection training. Instructors have the impression that participants perform better in dissection after the simulator training session has been introduced. Our pilot study suggests that participants perform better in the simulator compared to traditional dissection training. This could be due to a reduction of the cognitive load in the virtual simulator.

These observations lead to the hypothesis that virtual simulation training of mastoidectomy provides an effect that improves performance in traditional dissection training.

02

Conditions studied

  • Medical Education
  • User-Computer Interface
  • Clinical Skills
  • Motor Skills
  • Temporal Bone

Keywords

  • virtual simulation
  • temporal bone
  • surgical training
  • medical education
  • self-directed learning
  • final product assessment
  • cognitive load
  • reaction time
  • skills training
  • simulator metrics
03

In context

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous participation in formal mastoidectomy training in a virtual simulator
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Virtual simulation training first

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

    Other: Virtual simulation training

  • No intervention
    Dissection training first

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

Interventions

  • OtherVirtual simulation training

    Virtual simulation training in the Visible Ear Simulator.

06

What researchers measure

Primary outcomes

  1. Change in Final Product Assessment Score

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

    Time frame: 3 hours

Secondary outcomes

  1. Change in simulator metrics

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

    Time frame: 3 hours

  2. Change in reaction time

    Reaction time to a visual or auditory cue (in ms)

    Time frame: 3 hours

  3. Simulation experience

    Background data from a questionnaire including questions on prior simulation training and experience

    Time frame: At recruitment

  4. Demographics

    Background data from a questionnaire on participant demographics.

    Time frame: At recruitment

  5. Computer skills

    Background data from a questionnaire on experience and interests in computers and IT

    Time frame: At recruitment

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, DK-2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02030873
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Steven Andersen (MD, Rigshospitalet, Denmark) — Principal investigator
First posted
Jan 9, 2014
Start date
Jan 2014
Primary completion
Jan 2015
Completion
Jan 2015
Last update
May 5, 2015

Study contacts

Steven AW Andersen, MD
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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