Simulation-based Stress Inoculation Training Study for UK Medical Professionals

NCT05182710 | Unknown DMC

• 1 other identifier: 2021.RCHT.86
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess for the effectiveness of a Simulation-Based Stress Inoculation Training (SIT) Programme for junior doctors and physicians associates. It was well known that clinical practice can be stressful, particularly resuscitation events. When practitioners are stressed, they become less clinically effective. However, this is little in the way of training on how to manage acute stress in the workplace. Stress Inoculation Training is established in military and sports training but is yet to be researched fully in junior doctors or physicians associates. By integrating a SIT programme into regular simulation training, the study aims to assess whether it helps with managing stress and performing better resuscitation. This assessment will be via questionnaire, heart rate monitors and judgement of clinical performance. The study will be open to junior doctors and physicians associates who are currently practicing at the Royal Cornwall Hospital Trust and will take place in the Simulation Suite over a 6 month period. Results will be prepared for publication and circulated among participants

Conditions

Stress; Stress, Psychological; Stress, Job

Keywords

Stress Inoculation Training; SIT; NHS; Doctor; Resuscitation; Simulation; Medical Education

Outcome Measures

Primary Outcomes (2)

• Heart Rate Variability

  Difference in heart rate variability during simulated resuscitation events (objective measure)

  10 minutes during simulation scenario

• State-Trait Anxiety Inventory Difference

  Difference in State-Trait Anxiety Inventory (STAI) scores before and after resuscitation events (subjective measure)

  STAI takes about 1 minute to complete and participants will be asked to complete it 5 minutes before and 5 minutes after simulation event

Secondary Outcomes (4)

• Motor Task Capacity

  Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario

• Cognitive Capacity

  Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario

• Situational Awareness Capacity

  Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario

• Effectiveness of Resuscitation

  An independent assessor will review the videos of simulation events within 2 months of the simulation event. Each simulation should last around 10 minutes

Other Outcomes (1)

• Self-reported stress in real resuscitation events

  5 minute questionnaire conducted between 1 and 3 months following training and simulation event

Study Arms (2)

Stress Inoculation Training

EXPERIMENTAL

Intervention Arm

Behavioral: Stress Inoculation Training

Alternative Training

ACTIVE COMPARATOR

Best practice/control

Behavioral: Alternative Training

Interventions

Stress Inoculation Training BEHAVIORAL

The SIT programme/intervention will involve 1. 30 minute educational phase of preparatory information to allow participants to conceptualise the types of stressors they are likely to face and the role of stress on performance 2. 30 minutes of skills acquisition which will involve discussion of and teaching participants techniques to reduce stress in simulated resuscitation events 3. Inoculation through the application of acquired skills in 1-2 resuscitation scenarios

Stress Inoculation Training

Alternative Training BEHAVIORAL

1. 30 minutes of teaching on management of a drowning patient (in order that both control and intervention perceive they have had teaching of the same length as the other group) 2. 1-2 resuscitation simulation events (same scenario and tasks as in the intervention group)

Alternative Training

Eligibility Criteria

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

You may qualify if:

• Any medical professional (junior doctors or physicians associates) currently working part/full time at RCHT
• A current licence to practice
• Willing to consent to participate in the study

You may not qualify if:

• Anyone taking a medication which modifies heart rate (eg betablockers)
• Unwilling to consent to participate in the study

Sponsors & Collaborators

• Royal Cornwall Hospitals Trust: lead

Study Sites (1)

Post-Graduate Centre, Royal Cornwall Hospital NHS Trust

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

MeSH Terms

Conditions

Stress, Psychological; Occupational Stress

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Occupational Diseases

Study Officials

• Lewis Connolly, MBChB, FRSA

  National Health Service (NHS)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know which of the two interventions (training modules) is being assessed. Those facilitating simulations will also be blinded. Those assessing over-all effectiveness of resuscitation will be blinded to which arm participants are in
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: January 10, 2022
• Study Start: March 28, 2022
• Primary Completion: January 31, 2024
• Study Completion: August 30, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)