- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04776382
Eye Movement Modeling Examples as a Teaching Tool
Eye Movement Modeling Examples as a Teaching Tool for Epidural Block
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eye Movement Modeling Examples (EMME) is the youngest topic within the field of applied eye-tracking research in Educational Science. These are video recordings of a model executing a task and explaining how he goes about that. On top of that, the model's eye movements are tracked and replayed on top of the video.
It addresses the question, how visual expertise could be trained with the help of instructional videos of real-world tasks that are explained by experts in the field. These videos include an overlay of these experts' visual focuses to support the learner in connecting the verbal explanation of the expert to the real-world complexity of the task. The aim of this study will be to evaluate whether eye-tracking assisted teaching may improve the novice, inexperienced, trainee's performance in executing an epidural block on an epidural simulator and may change its visual patterns as assessed by eye-tracking glasses.
The study will enroll 14 novice trainees who will be randomized into two equal groups to receive (study group) or to don't receive (control group) a pre-recorded video (intervention) containing the instructions on where to focus their gaze while performing the epidural procedure.
All the trainees (study and control group) will be asked to perform the epidural procedure using a standardized epidural simulator while wearing eye-tracking glasses.
For this study, the investigators will use a commercially available Tobii Pro Glasses 50 Hz wearable wireless eye tracker. This system can measure eye movements using cameras integrated into the eyeglasses which record the corneal reflection of infrared lighting to track pupil position, mapping the subject's focus of attention on video recordings of the subject's field of vision (gaze).
All the eye-tracked epidural procedures will be recorded immediately after accurate individual calibration, during which the participant, after wearing the glasses unit, focused on the center of the calibration target.
All the eye-tracking video-recordings will be stored and analyzed by using Tobii Pro Lab Software. The investigators will select six areas of interest (AOI), to define regions of a displayed stimulus, and to extract metrics specifically for those regions. The areas were the following: 1) point of the epidural needle at its insertion into the skin; 2) shaft of the epidural needle; 3) hub of the needle; 4) barrel of the syringe; 5) plunger of the syringe; 6) other fields of view.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Roma, Italy, 00151
- EESOA srl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- inexperienced trainees in anesthesia who have never performed an epidural block
Exclusion Criteria:
- trainees who have previously performed an epidural block
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Trainees of this group will watch an EMME (Eye Movement Modeling Examples) pre-recorded video, on where to focus their gaze while performing the epidural procedure in accordance with expert eye-tracking
|
Trainees of this group will watch an EMME (Eye Movement Modeling Examples)-recorded video, on where to focus their gaze while performing the epidural procedure in accordance with expert eye-tracking
|
|
No Intervention: Control Group
Trainees of this group will not watch the pre-recorded video
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eye Fixations Numbers
Time Frame: up to 10 minutes
|
Duration (seconds) of fixations for each area of interest and for each phase will be examined. Fixations are represented as discrete samples of almost stable points where the eye is looking. Their duration is the elapsed time between the start of the first fixation on the AOI until the end of the last fixation on the AOI. The duration of fixations for each area of interest and for each phase will be examined. |
up to 10 minutes
|
|
Eye Fixation duration
Time Frame: up to 10 minutes
|
The number of fixations for each area of interest and for each phase will be examined. Fixations are represented as discrete samples of almost stable points where the eye is looking. The number of fixations for each area of interest and for each phase will be examined. |
up to 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Epidural attempt
Time Frame: up to 10 minutes
|
An attempt will be defined as a complete withdrawal of the needle from the epidural simulator's skin and its reinsertion at the same or at a different interspace
|
up to 10 minutes
|
|
Duration of the epidural procedure
Time Frame: up to 30 minutes
|
The total duration of the procedure will be defined as the length of time between the insertion of the epidural needle into the skin of the simulator and the completion of the loss of resistance technique (finding of the epidural space).
|
up to 30 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EESOA10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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