Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Eye Movement Modeling Examples as a Teaching Tool

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04776382
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2021
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
European e-Learning School in Obstetric Anesthesia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will evaluate whether eye-tracking assisted teaching (EMME, Eye Movement Modeling Examples) changes the visual patterns and improve the inexperienced trainee's performance in executing an epidural block on an epidural simulator.

Condition or disease Intervention/treatment Phase
Simulation Training Other: EMME (Eye Movement Modeling Examples) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Eye Movement Modeling Examples as a Teaching Tool for Epidural Block
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : October 28, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
 Other: EMME (Eye Movement Modeling Examples)
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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

  2. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • inexperienced trainees in anesthesia who have never performed an epidural block

Exclusion Criteria:

  • trainees who have previously performed an epidural block
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776382


Locations
Layout table for location information
Italy
EESOA srl
Roma, Italy, 00151
Sponsors and Collaborators
European e-Learning School in Obstetric Anesthesia
Investigators
Layout table for investigator information
Study Director: Giorgio Capogna, MD European e-Learning School in Obstetric Anesthesia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: European e-Learning School in Obstetric Anesthesia
ClinicalTrials.gov Identifier: NCT04776382    
Other Study ID Numbers: EESOA10
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No