Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000090819
Ethics application status
Approved
Date submitted
23/11/2020
Date registered
1/02/2021
Date last updated
1/02/2021
Date data sharing statement initially provided
1/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a novel stress mitigation method on the effects of stress on clinician physiology and decision-making during resuscitation
Scientific title
Evaluation of a novel stress mitigation method on the effects of stress on clinician physiology and decision-making during resuscitation
Secondary ID [1] 302841 0
None
Universal Trial Number (UTN)
U1111-1261-6308
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 319816 0
Condition category
Condition code
Emergency medicine 317748 317748 0 0
Resuscitation
Mental Health 318060 318060 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A stress mitigation intervention in the form of a smart phone app which will train the participants in stress-mitigation strategies:
The app will include training modules on the human stress response and evidenced based stress mitigation strategies such as resonant frequency breathing. Content will be in the form of text, explanatory diagrams and short video lectures. Participants will be expected to interact with app for 5-10 minutes each day for one month, to reiterate the concepts and practice some of the techniques. App analytics will be used to assess adherence to the intervention.

The simulated resuscitation will involve the participant undertaking the role of team leader for a simulated trauma resuscitation lasting for approximately 7 minutes. Participants will undertake two simulations, one low stress (LS) and one high stress (HS) with stressors identified from a prior systematic review by the authors. The simulation will be undertaken in the Centre for Health Innovation (CHI) simulation centre affiliated with the author's hospital. The simulation will be administered by the authors and an invited simulation expert who will give all participants (intervention and control) tailored feedback on their performance.

Following the intervention period participants will return to the the simulation centre and undertake a further HS scenario (HS2).

Stressors have been identified from our previous research (systematic review and survey study) including: patient illness severity / acuity, noise, conflict, time pressure, and socio-evaluative stress.
Intervention code [1] 319124 0
Behaviour
Comparator / control treatment
Participants randomised to the control group will receive detailed feedback on their performance during the first two simulations, HS and LS. Like the intervention group they receive no education / training prior to the first simulations.
Control group
Active

Outcomes
Primary outcome [1] 325780 0
Effect of scenario stress on physiological markers of the human stress response (heart rate variability, as determined using the standard deviation of NN intervals (SDNN) recorded using a Polar ECG heart rate monitor chest strap).
Timepoint [1] 325780 0
HRV will be assessed throughout all the (approximately 7 minute) simulated resuscitation scenarios (LS, HS and HS2). Other timepoints will include a baseline 10 minute measurement of HRV whilst participants are relaxing prior to the experiments.
Secondary outcome [1] 389121 0
Decision-making performance as assessed by a locally developed assessment tool for the individual scenarios.
Timepoint [1] 389121 0
Simulated resuscitation completion (<10 minutes).
Secondary outcome [2] 389122 0
Subjective stress markers (state trait anxiety inventory questionnaire).
Timepoint [2] 389122 0
Simulated resuscitation completion (<10 minutes).

Eligibility
Key inclusion criteria
Emergency medicine trainees (registrar level doctors registered with the Australasian College for Emergency Medicine (ACEM)).
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prior simulation fellowship training.
Simulation phobia (anticipated extreme response to simulation scenarios).
Antiarrhythmic medication (distortion of HRV markers).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assessing for mean change in the heart rate variability (HRV) marker SDNN (baseline to Stress Simulation Scenario) and estimating (mean) SDNN in Comparator (Education) group of 8ms (from prior study). We defined the reduction in SDNN change in Intervention (stress training) group considered to be important as a reduction of 50%. Sample size for a two-sample means test estimated to be 20 (10 randomised to each group).

Paired samples t-test for symmetric data or Wilcoxon Signed Rank test for asymmetric data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18074 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 32062 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 307261 0
Hospital
Name [1] 307261 0
The Alfred Hospital
Country [1] 307261 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The National Trauma Research Institute
Address
Level 4, 89 Commercial Rd,
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 307884 0
None
Name [1] 307884 0
Address [1] 307884 0
Country [1] 307884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307357 0
Alfred Health Ethics Committee
Ethics committee address [1] 307357 0
The Alfred Hospital
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 307357 0
Australia
Date submitted for ethics approval [1] 307357 0
24/04/2020
Approval date [1] 307357 0
19/05/2020
Ethics approval number [1] 307357 0
230/20

Summary
Brief summary
Team leading the resuscitation of a seriously injured or critical unwell patient can be stressful and this stress may affect the clinician’s ability to perform optimally, potentially adversely affecting patient care. Our recent systematic review of the literature revealed a paucity of studies looking at strategies for mitigating the effects of stress on clinician performance and this randomised controlled study will look at whether the deleterious effects of stress on clinician performance can be mitigated by a novel stress mitigation method.

Our plain language research question: During a simulated stressful resuscitation can a novel stress mitigation method ameliorate the effects of stress on:
1. Objective physiological stress measures
2. Subjective stress assessment
3. Decision-making performance

The primary outcome will be the ability of the intervention to ameliorate the change in physiological stress measures (based on real-time assessment of participants heart rate variability (HRV) during the simulated scenario as compared to their baseline). Secondary outcomes will be subjective measures of stress as well as an assessment of the effect of the intervention on the decision-making performance related to the scenario.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106950 0
Dr Christopher Groombridge
Address 106950 0
National Trauma Research Institute
Level 4, 89 Commercial Rd,
Melbourne VIC 3004
Country 106950 0
Australia
Phone 106950 0
+61 390762000
Fax 106950 0
Email 106950 0
c.groombridge@alfred.org.au
Contact person for public queries
Name 106951 0
Dr Christopher Groombridge
Address 106951 0
National Trauma Research Institute
Level 4, 89 Commercial Rd,
Melbourne VIC 3004
Country 106951 0
Australia
Phone 106951 0
+61 390762000
Fax 106951 0
Email 106951 0
c.groombridge@alfred.org.au
Contact person for scientific queries
Name 106952 0
Dr Christopher Groombridge
Address 106952 0
National Trauma Research Institute
Level 4, 89 Commercial Rd,
Melbourne VIC 3004
Country 106952 0
Australia
Phone 106952 0
+61 390762000
Fax 106952 0
Email 106952 0
c.groombridge@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.