Use of Stress Inoculation Training in Medical Education

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.

Study Overview

• Status: Terminated
• Conditions: Stress
• Intervention / Treatment: Behavioral: Stress Innoculation Training (SIT); Behavioral: Extra attempt

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Lecture; an initial brief lecture with no further training
Experimental: Stress management; an initial brief lecture with stress management lecture	Behavioral: Stress Innoculation Training (SIT); 1 hour lecture that will cover the conceptualization phase and skills-training phase portions of stress inoculation training.
Active Comparator: Hands-on training; an initial brief lecture with addition hands-on training for the task	Behavioral: Extra attempt; an extra attempt at intubating a mannequin configured at a difficulty level higher than will be used in the future scenarios
Experimental: Stress management and hands-on training; an initial brief lecture with both stress management lecture and additional hands-on training	Behavioral: Stress Innoculation Training (SIT); 1 hour lecture that will cover the conceptualization phase and skills-training phase portions of stress inoculation training.; Behavioral: Extra attempt; an extra attempt at intubating a mannequin configured at a difficulty level higher than will be used in the future scenarios

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Nathan J Lewis, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2021
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Medical Education; Simulation Training; Stress Inoculation
• Other Study ID Numbers: HM20014865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No