Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001214628
Ethics application status
Approved
Date submitted
19/10/2023
Date registered
27/11/2023
Date last updated
27/11/2023
Date data sharing statement initially provided
27/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive appraisal and stress response comparisons of final year paramedicine students
Scientific title
Threat versus challenge: cognitive appraisal and stress response comparisons of final year paramedicine students undertaking high-acuity scenarios
Secondary ID [1] 310818 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CoverT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiological Stress 331808 0
Cognitive stress 331809 0
Condition category
Condition code
Neurological 328556 328556 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants role play as first responders in an emergency situation and undertake a high-acuity medical scenario. The approximate duration of the scenario is 30 minutes and participants complete this alone. Quantitative assessments are completed pre and post scenario.
Across the following days, training and education will be provided to establish a challenge mindset in the participants. The training involves participants undertaking self-directed observation of short videos and completing online interactive clinical learning modules. These modules are existing components of the current Bachelor of Paramedicine curriculum. They include overviews of pathophysiology of conditions such as anaphylaxis, severe asthma, opioid overdose (as some examples) and also include pharmacodynamics of medications used to treat patients presenting in high acuity situations. Participants are asked to spend 1 hour per day across a seven day period completing this training online. A paramedicine instructor is available to answer email queries across this period. Participants are also given a copy of an short (7 page) manual with tips and suggestions to allow a challenge mindset to be developed instead of a threat appraisal. This learning manual has been developed specifically for this study. Within the learning manual, participants are asked to check a box daily to indicate they have completed their one hour of self-directed training.
Seven days after the original scenario, the same participants will complete a different but equivalent scenario. Participants serve as their own control and are assessed pre and post scenario in both occurrences.
Intervention code [1] 327230 0
Behaviour
Comparator / control treatment
Participants serve as their own control and are assessed pre and post scenario in both occurrences. The control group will also not have access to tailored training and education provided to the intervention group
Control group
Active

Outcomes
Primary outcome [1] 336362 0
Cardiovascular physiological responses.
Timepoint [1] 336362 0
will be measured continuously throughout the scenario and presented as composite outcome to gauge cardiovascular physiological responses during each of the two scenarios.
Primary outcome [2] 336448 0
Endocrine (salivary cortisol) as a measure of acute stress
Timepoint [2] 336448 0
Samples will be taken pre and post both scenarios (4 samples for cortisol for each participant with 2 taken on day 1 / scenario 1 and 2 taken 7 days later for scenario 2)
Primary outcome [3] 336558 0
Blood glucose levels (BGL) as a measure of acute stress
Timepoint [3] 336558 0
Samples will be taken pre and post both scenarios (4 samples for BGL for each participant with 2 taken on day 1 / scenario 1 and 2 taken 7 days later for scenario 2)
Secondary outcome [1] 428017 0
Brain activity assessed using Functional near-infrared spectroscopy (fNIRS)
Timepoint [1] 428017 0
Collected continuously throughout each scenario on 2 separate occasions (7 days apart).

Eligibility
Key inclusion criteria
1. Participants must be proficient in English because the tasks require communication.
2. To maintain a consistent level of academic ability, only students with a GPA of 5.0 and above are considered to be eligible participants.
3. Final year undergraduate Bachelor of paramedicine students will be targeted for recruitment into this study. If eligible student numbers are low, then cross-institutional recruitment may be explored via email though other universities in Victoria that offer a recognised paramedicine degree and Facebook posts via their student societies.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included diagnosed anxiety or stress-related disorders, those taking medication which affects the central nervous system or cardiovascular system (e.g. medications for epilepsy, anxiety, mood disorders, sleeping tablets such as Stilnox, benzodiazepines, melatonin or beta blockers).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size will be estimated based on pilot study data. The pilot study (Study 1) will use the same experimental design, variables, measures, and recruitment methods as for the main experiment (Study 2). I will use the pilot study to perform a statistical power analysis and to estimate the final N needed. Relatable studies have utilised sample sizes ranging from N=13 (Harvey et al., 2010) to N=120 (Moore et al., 2014), with N=22 (Leblanc et al., 2012), N=30 (LeBlanc et al., 2005) and N=52 (Vine et al., 2013) in between. Working from the power calculation (two-side, two-sample t-test) published by Harvey et al. (2010), I have updated the expected standard deviation and means from the Demand and Resource questionnaire (Stressor Appraisal Scale (SAS)) questionnaire. The SAS is a 10 question, 7 Likert scale, questionnaire. Using a mean value of 30 and 40 for the two conditions and a standard deviation of 30 to encompass a significant change of 15-20 points – the significance tests modelled in GPower will be tests of independent groups. For example, using estimate for a two-sided, two-sample t-test within GPower, a Power (1-ß) of 0.20, a Type 1 error rate (a) of 5% and accepted means and standard deviations as stated – the estimated sample size is 23. To account for the requested 30% drop out rate, and to accommodate more robust data, the sample size will be 40 with 20 randomly allocated to each condition.

The main focus of this research project is to assess if the appraisal of a stressful scenario can be shifted from ‘threat’ state to ‘challenge’ state in the novice clinician. To obtain objective measures of threat and challenge states, quantitative data will be obtained as outlined above. Statistical analysis will be completed using SPSS version 28 (SPSS Inc; Chicago, IL, USA) and GraphPad Prism version 5.0 (GraphPad Software, San Diego, CA, USA). All data reported as median ± IQR, and means ± SD, with significance determined with p <0.05. Non-parametric and other statistics associated with small n designs, typically used for evaluation of design frameworks within educational research, will be undertaken to determine difference (if any) between cognitive and stress data in the control and intervention arms of this project.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/10/2023
Date of last participant enrolment
Anticipated
7/10/2024
Actual
Date of last data collection
Anticipated
9/12/2024
Actual
Sample size
Target
40
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315058 0
Commercial sector/Industry
Name [1] 315058 0
Australasian College of Paramedicine
Country [1] 315058 0
Australia
Funding source category [2] 315059 0
University
Name [2] 315059 0
Australian Catholic University
Country [2] 315059 0
Australia
Funding source category [3] 315060 0
University
Name [3] 315060 0
University of Southern Queensland
Country [3] 315060 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
487-535 West St, Toowoomba, Qld 4350
Country
Australia
Secondary sponsor category [1] 317081 0
University
Name [1] 317081 0
Australian Catholic University
Address [1] 317081 0
25A Barker Rd, Strathfield NSW 2135
Country [1] 317081 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314012 0
University of Southern Queensland’s Human Research Ethics Committee
Ethics committee address [1] 314012 0
Ethics committee country [1] 314012 0
Australia
Date submitted for ethics approval [1] 314012 0
12/07/2021
Approval date [1] 314012 0
26/08/2021
Ethics approval number [1] 314012 0
H21REA158
Ethics committee name [2] 314013 0
Australian Catholic University HREC
Ethics committee address [2] 314013 0
Ethics committee country [2] 314013 0
Australia
Date submitted for ethics approval [2] 314013 0
30/08/2021
Approval date [2] 314013 0
10/09/2021
Ethics approval number [2] 314013 0
2021-204R

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130118 0
Mr Jason Betson
Address 130118 0
Australian Catholic University, Faculty of Health, Level 4, Daniel Mannix Building, 115 Victoria Parade, Fitzroy, VIC 3065
Country 130118 0
Australia
Phone 130118 0
+61399533503
Fax 130118 0
Email 130118 0
jason.betson@acu.edu.au
Contact person for public queries
Name 130119 0
Jason Betson
Address 130119 0
Australian Catholic University, Faculty of Health, Level 4, Daniel Mannix Building, 115 Victoria Parade, Fitzroy, VIC 3065
Country 130119 0
Australia
Phone 130119 0
+61399533503
Fax 130119 0
Email 130119 0
jason.betson@acu.edu.au
Contact person for scientific queries
Name 130120 0
Jason Betson
Address 130120 0
Australian Catholic University, Faculty of Health, Level 4, Daniel Mannix Building, 115 Victoria Parade, Fitzroy, VIC 3065
Country 130120 0
Australia
Phone 130120 0
+61399533503
Fax 130120 0
Email 130120 0
jason.betson@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual de-identified participant data underlying published results only
When will data be available (start and end dates)?
Following publication of study results - estimated to be mid to late 2025 with no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose, only to achieve the aims in the approved proposal and to further research in this field
How or where can data be obtained?
access subject to approvals by Principal Investigator (jason.betson@acu.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20686Study protocol  jason.betson@acu.edu.au 386765-(Uploaded-19-10-2023-10-38-51)-Study-related document.docx
20687Informed consent form  jason.betson@acu.edu.au 386765-(Uploaded-19-10-2023-10-40-01)-Study-related document.docx
20688Other  jason.betson@acu.edu.au Participant information sheet 386765-(Uploaded-19-10-2023-10-41-13)-Study-related document.pdf



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.