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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04199221
Other study ID # HM20014865
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 26, 2021
Est. completion date December 29, 2023

Study information

Verified date December 2023
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to test the feasibility and effectiveness of SIT in teaching medical students to perform in high-fidelity simulation settings similar to those they may experience in their practice.


Description:

This is a study examining stress inoculation training and its potential role in medical education. The medical field exposes students and providers to various stressful situations each and every day. Various organizations including military organizations have introduced concepts of stress inoculation training (SIT) to help learners manage these situations to produce optimal performance.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date December 29, 2023
Est. primary completion date December 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1st and 2nd year medical students who are at least 18 years old Exclusion Criteria: - Prior airway management experience (including but not limited to former medics, respiratory technicians, CRNAs) - Pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stress Innoculation Training (SIT)
1 hour lecture that will cover the conceptualization phase and skills-training phase portions of stress inoculation training.
Extra attempt
an extra attempt at intubating a mannequin configured at a difficulty level higher than will be used in the future scenarios

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in anxiety - visual analog Change in anxiety will be assessed using the Visual Anxiety Scale (VAS/VAS-A), a widely used scale that has been validated in multiple settings to detect changes in anxiety level. A 10cm line will be drawn on the screen and participants will be asked to rate their level of anxiety by clicking somewhere on the line - the leftmost portion coinciding with no anxiety, the rightmost portion coinciding with extreme anxiety. Each millimeter to the right of the initial start of the line counts as 1 point out of 100. Baseline to up to 3 weeks
Primary Change in state-trait anxiety Spielberger State-Trait Anxiety Inventory 6 (STAI-6) will be used to measure state-trait anxiety. The STAI-6 is a validated 6-question form of the STAI-Y, a commonly used and validated measure of anxiety. Baseline to up to 3 weeks
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