- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01966185
Establishing Learning Curves in Virtual Simulation Training of Mastoidectomy
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Copenhagen, Danmark, DK-2100
- Rigshospitalet
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- medical students
- informed written consent
Exclusion Criteria:
- prior training on the Visible Ear Simulator
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Tutor function off
The tutor function will be off for 12 out of 12 repeat simulations.
|
|
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Experimentell: Tutor function on
The group will have the tutor function on for the 5 first out of 12 repeat simulation sessions.
|
The simulator-integrated tutor function with volumetric green lighting of the intended volume to be drilled.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Final Product Assessment Score
Tidsram: 4 months
|
Mastoidectomy final product assessment score using a modified Welling Scale for performance assessment.
|
4 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in simulator metrics
Tidsram: 4 months
|
Integrated simulator metrics on volume drilled (inside+outside target volumes), collisions with vital structures in simulation, time.
|
4 months
|
|
Change in reaction time
Tidsram: 4 months
|
Reaction time to a visual cue (in ms)
|
4 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Background data
Tidsram: At recruitment
|
Background data from a questionnaire including questions on demographics, prior simulation training and experience and interests in computers and IT
|
At recruitment
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Steven AW Andersen, MD, Rigshospitalet, Denmark
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- H-4-2013-FSP-088
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