Simulation-Based Stress Inoculation Training

NCT03233750 | Completed

• 1 other identifier: 20170081-01H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Previous research has shown that health professionals can experience stress responses during high acuity events such as trauma resuscitations. These stress responses can lead to impaired clinical performance. The goal of this proposed project is to adapt Stress Inoculation Training (SIT) to the healthcare setting. Stress Inoculation Training is a cognitive-behavioural approach to stress management that has proven effective in reducing stress and improving performance in domains outside of healthcare. Thirty-two emergency medicine residents will be randomly divided into two groups. The SIT group will receive the simulation-based stress inoculation training. We will measure the effectiveness of the training by looking at reduction of stress levels and improvements in clinical performance in a pre-intervention and a post-intervention simulated trauma scenario. The control group will be exposed to the same simulation scenarios and pre/post intervention scenarios as the SIT group, but will not receive the stress inoculation training.

Conditions

Stress, Psychological

Outcome Measures

Primary Outcomes (2)

• Change in scores on State-Trait Anxiety Inventory

  Subjective stress measure

  prior to each scenairo as well as immediately at the end of each simulation scenario

• Change in salivary cortisol levels

  physiological indicator of stress

  prior to each scenario, as well as 20 and 30 minutes after each scenario

Secondary Outcomes (1)

• Performance

  Experts will review the videotapes of the scenarios within one month of data collection

Study Arms (2)

Stress Inoculation Training

EXPERIMENTAL

Phase 1: Conceptualization / Educational Phase (60 minutes) Provision of preparatory information, to allow the participants to form accurate expectations regarding the stress environment and stress reactions. Phase 2: Skill Acquisition and Rehearsal (60 minutes) Development and practice of cognitive restructuring techniques and relaxing training to reduce anxiety and enhance the individual's capacity to respond effectively to stressful situations, in low stress conditions. Phase 3: Application of Coping Skills (180 minutes) Coping skills are applied in increasingly stressful conditions that approximate the real-world stressor environment.

Behavioral: Stress Inoculation Training

Crisis Resource Management Training

ACTIVE COMPARATOR

The CRM training targets the non-technical skills (e.g. behavioural and cognitive skills) required for effective teamwork during crisis situations. It focuses on communication, teamwork, situational awareness and leadership

Behavioral: Crisis Resource Management

Interventions

Stress Inoculation Training BEHAVIORAL

see description in arm/group descriptions

Stress Inoculation Training

Crisis Resource Management BEHAVIORAL

During each scenario, facilitators identify performance gaps in either situation awareness, leadership, communication or resource allocations. During debriefing session, these are raised with the learner and their cognitive frames are identified and corrected as necessary.

Crisis Resource Management Training

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Emergency medicine residents enrolled in post graduate training at the University of Toronto or the University of Ottawa

You may not qualify if:

• endocrine disease or medication that can affect cortisol levels or responses

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• University of Toronto: collaborator

Study Sites (1)

University of Ottawa Skills and Simulation Centre

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Crew Resource Management, Healthcare

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration

Study Officials

• Vicki LeBlanc, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Group assignment will be masked from the assessors of performance. Expert educators will score videotaped performances of the participants obtained pre and post intervention. Assessors will be blinded to group allocation as well as to whether the video they are scoring is of the pre or the post intervention scenario.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cohort study, comparing two interventions aimed at decreasing stress responses during acute events, with a pre and a post intervention assessment.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 31, 2017
• Study Start: September 15, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CA (1)