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Simulation-based Stress Inoculation Training Study for UK Medical Professionals (SITS)

Primary Purpose

Stress, Stress, Psychological, Stress, Job

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Stress Inoculation Training
Alternative Training
Sponsored by
Royal Cornwall Hospitals Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress focused on measuring Stress Inoculation Training, SIT, NHS, Doctor, Resuscitation, Simulation, Medical Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Post-Graduate Centre, Royal Cornwall Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stress Inoculation Training

Alternative Training

Arm Description

Intervention Arm

Best practice/control

Outcomes

Primary Outcome Measures

Heart Rate Variability
Difference in heart rate variability during simulated resuscitation events (objective measure)
State-Trait Anxiety Inventory Difference
Difference in State-Trait Anxiety Inventory (STAI) scores before and after resuscitation events (subjective measure)

Secondary Outcome Measures

Motor Task Capacity
Difference in time (seconds) taken to perform a fine motor task. This task will involve insertion of catheter onto guide wire during simulated resuscitation event
Cognitive Capacity
Difference in time (seconds) taken to perform a cognitive task. This task will involve interpreting an Electrocardiogram (ECG) or Arterial Blood Gas (ABG) during simulated resuscitation event
Situational Awareness Capacity
Difference in time (seconds) taken to demonstrate situational awareness. This task will involve participants recognising a device failure such as detachment of ECG leads and loss of ECG trace during simulated resuscitation event
Effectiveness of Resuscitation
Difference in overall performance as assessed by independent expert. The expert will be asked to rank the overall effectiveness of the resuscitation on a scale of 1 to 10 where 1 is entirely ineffective resuscitation and 10 is entirely effective resuscitation

Full Information

First Posted
November 8, 2021
Last Updated
March 28, 2023
Sponsor
Royal Cornwall Hospitals Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05182710
Brief Title
Simulation-based Stress Inoculation Training Study for UK Medical Professionals
Acronym
SITS
Official Title
Preparing for the Stress of Resuscitation: A Randomised Control Trial of Simulation-based Stress Inoculation Training for UK Medical Professionals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Cornwall Hospitals Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
This study is a randomised control trial design. The study aim is to obtain 40 participants of varied roles, all healthcare professionals at the NHS RCHT. Participants will be asked to sign up to a session run in regular working hours at the RCHT simulation suite. If participants wish to take part in the study, after being consented to the project, they will be randomised to either the intervention arm or control arm. Best practice/control is as follows 30 minutes of teaching on management of a drowning patient (or similar topic, in order that both control and intervention perceive they have had teaching of the same length as the other group) 1-2 resuscitation simulation events (same scenario and tasks as in the intervention group) The SIT programme/intervention will involve 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 30 minutes of skills acquisition which will involve teaching participants techniques to reduce stress in simulated resuscitation events Inoculation through the application of acquired skills in 1-2 resuscitation scenarios All participants will be asked to complete a State-Trait Anxiety Inventory (STAI) questionnaire both prior to and immediately after the end of each scenario All participants will have their heart rates monitored throughout the session with timings correlated against stressors and application of stress reduction techniques All participants will have the same set of scenarios involving the same tasks. Performance at individual tasks (such as cannulation, guide wire fitting, ECG interpretation, ABG interpretation, recalling allergies, noticing equipment failure) and overall performance will be assessed by an independent, blinded assessors according to a pre-determined score scheme using video footage of each scenario Scenarios will be facilitated by blinded researchers. These facilitators will be members of the simulation team. For the duration of the session, they will be based on the simulation room and not take part in the training modules. They will not be aware if simulation participants are part of the control or intervention group. They will be tasked with running the simulation scenario with consistency across participants. Data analysis will include using MSExcel to test for statistically significant differences in biomarkers, self-reported scores and independent, blinded assessor scores. All results will be identified by using an anonymous code for each participant which will reference only their job role and whether they are in the intervention or control group* (badges will be worn by participants for identification). *this may have to be done via a code so independent assessors watching the videos do not know Data, including videos of the simulation session, photocopies of the STAI questionnaire and transcribed heart rate values will be stored anonymously on the RCHT server and not copied across to any personal or other devices. It will only be accessed my primary researchers. Videos will be stored in a separate folder which the independent assessor will have access to and photocopies of their mark schemes will be uploaded to the RCHT server also. All paper forms will be shredded using the hospital's existing system for disposal of confidential waste

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Stress, Psychological, Stress, Job
Keywords
Stress Inoculation Training, SIT, NHS, Doctor, Resuscitation, Simulation, Medical Education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Control Trial
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress Inoculation Training
Arm Type
Experimental
Arm Description
Intervention Arm
Arm Title
Alternative Training
Arm Type
Active Comparator
Arm Description
Best practice/control
Intervention Type
Behavioral
Intervention Name(s)
Stress Inoculation Training
Intervention Description
The SIT programme/intervention will involve 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 30 minutes of skills acquisition which will involve discussion of and teaching participants techniques to reduce stress in simulated resuscitation events Inoculation through the application of acquired skills in 1-2 resuscitation scenarios
Intervention Type
Behavioral
Intervention Name(s)
Alternative Training
Intervention Description
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) 1-2 resuscitation simulation events (same scenario and tasks as in the intervention group)
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
Difference in heart rate variability during simulated resuscitation events (objective measure)
Time Frame
10 minutes during simulation scenario
Title
State-Trait Anxiety Inventory Difference
Description
Difference in State-Trait Anxiety Inventory (STAI) scores before and after resuscitation events (subjective measure)
Time Frame
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 Outcome Measure Information:
Title
Motor Task Capacity
Description
Difference in time (seconds) taken to perform a fine motor task. This task will involve insertion of catheter onto guide wire during simulated resuscitation event
Time Frame
Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario
Title
Cognitive Capacity
Description
Difference in time (seconds) taken to perform a cognitive task. This task will involve interpreting an Electrocardiogram (ECG) or Arterial Blood Gas (ABG) during simulated resuscitation event
Time Frame
Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario
Title
Situational Awareness Capacity
Description
Difference in time (seconds) taken to demonstrate situational awareness. This task will involve participants recognising a device failure such as detachment of ECG leads and loss of ECG trace during simulated resuscitation event
Time Frame
Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario
Title
Effectiveness of Resuscitation
Description
Difference in overall performance as assessed by independent expert. The expert will be asked to rank the overall effectiveness of the resuscitation on a scale of 1 to 10 where 1 is entirely ineffective resuscitation and 10 is entirely effective resuscitation
Time Frame
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 Pre-specified Outcome Measures:
Title
Self-reported stress in real resuscitation events
Description
Difference in self reported stress at work after simulated resuscitation event. Participants will be asked to rank their level of stress/anxiety on a scale of 1 to 10 in three scenarios: anticipation of a real resuscitation event, during a real resuscitation event, after a real resuscitation event
Time Frame
5 minute questionnaire conducted between 1 and 3 months following training and simulation event

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Anyone taking a medication which modifies heart rate (eg betablockers) Unwilling to consent to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis Connolly, MBChB, FRSA
Organizational Affiliation
National Health Service (NHS)
Official's Role
Study Chair
Facility Information:
Facility Name
Post-Graduate Centre, Royal Cornwall Hospital NHS Trust
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate data will be shared generally. Individual level data will only be shared within the primary research team and only when strictly necessary

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Simulation-based Stress Inoculation Training Study for UK Medical Professionals

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