NCT04776382

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 25, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

March 23, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

February 24, 2021

Last Update Submit

March 22, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Eye Fixations Numbers

    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

    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 Outcomes (2)

  • Epidural attempt

    up to 10 minutes

  • Duration of the epidural procedure

    up to 30 minutes

Study Arms (2)

Study Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

Trainees of this group will not watch the pre-recorded video

Interventions

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

Study Group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • trainees who have previously performed an epidural block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EESOA srl

Roma, 00151, Italy

Location

Study Officials

  • Giorgio Capogna, MD

    European e-Learning School in Obstetric Anesthesia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 1, 2021

Study Start

March 25, 2022

Primary Completion

October 28, 2022

Study Completion

October 28, 2022

Last Updated

March 23, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations