StressSITSNCT05182710
Simulation-based Stress Inoculation Training Study for UK Medical Professionals
A study testing Stress Inoculation Training and Alternative Training in people with Stress and Stress, Psychological, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Stress, Psychological, Stress, Job
- What is being tested?
- Stress Inoculation Training and Alternative Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anyone taking a medication which modifies heart rate (eg betablockers)
- Unwilling to consent to participate in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Post-Graduate Centre, Royal Cornwall Hospital NHS Trust
Truro, Cornwall, TR1 3LJ
About this study
Official title: Preparing for the Stress of Resuscitation: A Randomised Control Trial of Simulation-based Stress Inoculation Training for UK Medical Professionals
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.
Read more
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
Read the 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
- Conditions
- Stress, Stress, Psychological, Stress, Job
- Being tested
- Stress Inoculation Training, Alternative Training
- Keywords
- Stress Inoculation Training, SIT, NHS, Doctor, Resuscitation, Simulation, Medical Education
- Medical subject headings
- Stress, Psychological, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Inoculation TrainingBehavioural
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
Alternative TrainingBehavioural
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Stress Inoculation Training | Experimental | Intervention Arm Receives: Behavioral: Stress Inoculation Training |
| Alternative Training | Active comparator | Best practice/control Receives: Behavioral: Alternative Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Difference in heart rate variability during simulated resuscitation events (objective measure)
Measured: 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)
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: An independent assessor will review the videos of simulation events within 2 months of the simulation event. Each simulation should last around 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start28 Mar 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lewis Connolly, MBChB, FRSA, Study chair, National Health Service (NHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182710
- Sponsor's protocol ID
- 2021.RCHT.86
- Acronym
- SITS
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data will be shared generally. Individual level data will only be shared within the primary research team and only when strictly necessary
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing for the Stress of Resuscitation: A Randomised Control Trial of Simulation-based Stress Inoculation Training for UK Medical Professionals
- ClinicalTrials.gov ID
- NCT05182710
- Acronym / sponsor ID
- SITS / 2021.RCHT.86
- Conditions
- Stress, Stress, Psychological, Stress, Job
- Keywords
- Stress Inoculation Training, SIT, NHS, Doctor, Resuscitation, Simulation, Medical Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| Stress Inoculation Training | Experimental | Behavioral: Stress Inoculation TrainingIntervention Arm |
| Alternative Training | Active comparator | Behavioral: Alternative TrainingBest practice/control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Anyone taking a medication which modifies heart rate (eg betablockers)
- Unwilling to consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Inoculation TrainingThe 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 | Behavioural | Stress Inoculation Training |
| Alternative Training1. 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) | Behavioural | Alternative Training |
Primary outcome
Heart Rate Variability
Time frame: 10 minutes during simulation scenario
Difference in heart rate variability during simulated resuscitation events (objective measure)
State-Trait Anxiety Inventory Difference
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
Difference in State-Trait Anxiety Inventory (STAI) scores before and after resuscitation events (subjective measure)
4 secondary outcomes
Motor Task Capacity
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
Cognitive Capacity
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
Situational Awareness Capacity
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
Effectiveness of 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No. Aggregate data will be shared generally. Individual level data will only be shared within the primary research team and only when strictly necessary
Related trials for Stress
Recruiting
Mental Stress Reactivity in Women With CMD
Post-menopause
Recruiting
Evaluating Evidenced Based Options for PTSD Treatment
PTSD - Post Traumatic Stress Disorder
Recruiting
Structural Heat Adaptation and Education in Urban Setting
Heat Illness, Quality of Life
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
Gardening Activities, Stress, and Social Interaction Among University Students
Psychosocial Wellbeing, Perceived Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis Connolly, MBChB, FRSA study chair
National Health Service (NHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Inoculation Training and Alternative Training in people with Stress and Stress, Psychological, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: 10 minutes during simulation scenario). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023; AzTrials last refreshed its copy on 29 Oct 2026.