Use of Stress Inoculation Training in Medical Education

NCT04199221 | Terminated

• 1 other identifier: HM20014865
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress

Keywords

Stress Inoculation; Medical Education; Simulation Training

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Lecture

NO INTERVENTION

an initial brief lecture with no further training

Stress management

EXPERIMENTAL

an initial brief lecture with stress management lecture

Behavioral: Stress Innoculation Training (SIT)

Hands-on training

ACTIVE COMPARATOR

an initial brief lecture with addition hands-on training for the task

Behavioral: Extra attempt

Stress management and hands-on training

EXPERIMENTAL

an initial brief lecture with both stress management lecture and additional hands-on training

Behavioral: Stress Innoculation Training (SIT); Behavioral: Extra attempt

Interventions

Stress Innoculation Training (SIT) BEHAVIORAL

1 hour lecture that will cover the conceptualization phase and skills-training phase portions of stress inoculation training.

Stress management; Stress management and hands-on training

Extra attempt BEHAVIORAL

an extra attempt at intubating a mannequin configured at a difficulty level higher than will be used in the future scenarios

Hands-on training; Stress management and hands-on training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• st and 2nd year medical students who are at least 18 years old

You may not qualify if:

• Prior airway management experience (including but not limited to former medics, respiratory technicians, CRNAs)
• Pregnant women

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

• Nathan J Lewis, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: August 26, 2021
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)