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Trial registered on ANZCTR


Registration number
ACTRN12623000081617
Ethics application status
Approved
Date submitted
17/01/2023
Date registered
25/01/2023
Date last updated
25/01/2023
Date data sharing statement initially provided
25/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Practical Examination Stress in Undergraduate Physiotherapy Students (PESiPs)
Scientific title
Level and Temporal Variations in Practical Examination Stress Measured Using Salivary Cortisol Concentrations, Heart Rate Variability, and Self-Perceived Stress in Physiotherapy Students, During the Pre-Clinical Practicum Period of an Undergraduate Degree.
Secondary ID [1] 308770 0
None
Universal Trial Number (UTN)
Trial acronym
PESiPs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 328714 0
Anxiety 328759 0
Condition category
Condition code
Mental Health 325724 325724 0 0
Anxiety
Mental Health 325768 325768 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective, observational study with cross-sectional and longitudinal components to report the levels of student stress during practical examinations. The study will be conducted over seven or nine consecutive university study periods. The study may be terminated after seven study periods if sufficient participants have been recruited to achieve sample size estimate. This will eliminate any unnecessary testing and study commitment for participants. Each study period runs for 13 weeks with two study periods per academic year. Study period 1 commences in February, and study period 2 commences in July. Cohorts will be followed from recruitment to termination of study period 1 of their 3rd year in the physiotherapy undergraduate degree at JCU. Thus data will be collected at four time points each sin five time periods.
The outcome measures employed include perceived stress scores using the PSS10 questionnaire, salivary cortisol measured using saliva sampling (CSST) and heart rate variability extrapolated from heart rate using a PolarH10© heart rate monitor (HRM). All measures will be administered and extracted using standardised valid and reliable methods. The CSST analysis will be conducted in PC2 laboratories of the, Australian Institute of Tropical Health and Medicine, JCU. All outcome measures will be conducted at each data collection time point (T1-4) in each university study period.
-The CSST, takes approximately 5-7 minutes to administer. Saliva is collected using a technique where the student places a swab attached to a plastic tube into their mouth. When sufficient saliva has been absorbed, the swab is placed into a collection tube and sealed for processing. Salivary tests have been advocated for studies which investigate stress, as unlike urine or blood sampling they appear to cause less anxiety during sample collection (1).
-The PSS10, is a 10-item instrument to measure perceived stress over the previous month (1,2).The PSS10 takes approximately 5 minutes to administer.
- Heart Rate variability, will be extrapolated using customised software (Kubios©) using heart rate monitoring captured on a chest mounted HRM. The HRM is attached and maintained on the participant’s chest below nipple line via an elasticated strap secured by velcro. Change in HR, and HRV data will be transferred to a computer for further analysis.
Recruitment will occur at the beginning of each study period (1 and 2) for the duration of the research. Recruitment will be promoted through advertising recruitment posters, placed in the university's health sciences precinct which has a high presence and visible of physiotherapy students. .Participants will be invited to continue their participation in the study on an annual basis (January of each year) and renewed consent will be gained and signed each year.
The four data collection points for each university study period are as follows: T1-Week 3 Data Collection Baseline (duration 20-25 minutes).•T2-Week 8 Data Collection Mid Study Period (duration 20-25 minutes).•T3-Week 13 Data Collection Pre-Practical Examination (duration 20-25 minutes).•T4-Week 13 Data Collection Post-Practical Examination (duration approximately 60minutes).
Data collection process will be as follows: At T1, and T2 participants will complete the PSS10 while sitting quietly in the data collection room, following which one CSST will be obtained, and the HRM will be applied and remain in situ to record resting HR for 10 minutes. At T3 a CSST will be obtained from the participant, following this the HRM will be applied and HR will be recorded continuously. The participant will then sit quietly to complete the PSS10. Saliva collection, HRM application and completion of the PSS10 is expected to take no longer than 25 minutes. As the HRM self-stores HR recordings, no members of the research team will enter the practical examination room at any time. Therefore, the HRM via the chest mounted strap will not be removed between T3 and T4, to allow continuous and uninterrupted HR recording before, during,and 10 mins post-examination. T4 will begin at completion of the practical examination when the student exits the examination room. The HRM will already be in situ, the student will be guided to the quiet data collection room, so resting HR can be recorded for 10 minutes post-examination. At T4 the participant will not complete the PSS10, but will be invited to remain in the data collection room for a maximum of 60 minutes, during which they will complete CSSTs at 30-and 60-minutes post-examination. Following T4 completion, the study is complete, and the participant is free to exit the data collection room.
(1).Hellhammer, D. H., Wüst, S., Kudielka, B. M.,Salivary cortisol as a biomarker in stress research.Psychoneuroendocrinology,2009.34, 163—171
(2). Cohen, S., & Williamson, G.M.,Perceived stress in a probability sample of the united states.In S. Spacapan, & Oskamp, S. (Ed.), The social psychology of health: Claremont symposium on applied social psychology,1988. Newbury Park, CA: Sage.
(3). Cohen, S., Kamarck, T., & Mermelstein, R.,A global measure of perceived stress.Journal of Health & Social Behaviour,1983. 24(4), 385-396. doi:10.2307/2136404
Intervention code [1] 325221 0
Early Detection / Screening
Comparator / control treatment
We will compare two non- practical examination time points (control = (early, T1 and mid, T2 study period) with practical examination time (exposure =T3 & 4)
Control group
Active

Outcomes
Primary outcome [1] 333574 0
Level of perceived stress scored using the perceived stress scale (pss-10)
Timepoint [1] 333574 0
T1-Week 3 Data Collection Baseline,
T2-Week 8 Data Collection Mid Study Period, and
T3-Week 13 Data Collection Pre-Practical Examination
Primary outcome [2] 333575 0
Salivary cortisol levels measured by a salivary cortisol test (CSST)
Timepoint [2] 333575 0
T1-Week 3 Data Collection Baseline,
T2-Week 8 Data Collection Mid Study Period,
T3-Week 13 Data Collection Pre-Practical Examination, and
T4-Week 13 Data Collection Post-Practical Examination
Primary outcome [3] 333576 0
HR measured by a PolarH10© HRM and HRV extrapolated from HR recordings
Timepoint [3] 333576 0
T1-Week 3 Data Collection Baseline,
T2-Week 8 Data Collection Mid Study Period,
T3-Week 13 Data Collection Pre-Practical Examination, and
T4-Week 13 Data Collection Post-Practical Examination
Secondary outcome [1] 417578 0
nil
Timepoint [1] 417578 0
nil

Eligibility
Key inclusion criteria
-Currently enrolled in years one, two, or study period 1 of year three, of the James Cook University Bachelor of Physiotherapy degree.
-Undertaking practical skills examinations in either first, second or third year subjects
-Willing and able to complete the PSS10, wear a HRM, and have CSSTs conducted at four data collection time points during each study period.
-Willing and able to provide informed, written consent.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Students enrolled in another degree programme (not physiotherapy)
- Students who have undertaken the practical examination for a given subject previously (eg, if they failed the practical exam at previous attempt of the same practical exam)

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We aim to recruit 110 participants, based on previous research [1].
Each cohort will be treated as a cluster for statistical analysis. In this way, analysis within and between clusters can be undertaken. Analysis using an analysis of variance or non-parametric alternative as appropriate, will be used for continuous data. Categorical data will be analysed using X2 tests as indicated.

[1]. Ramirez-Adrados, A., Fernández-Martíneza, S., Martínez-Pascuala, B., Gonzalez-de-Ramosa, C., Fernández-Elíasa, V. E., Clemente-Suáreza, V. J., Psychophysiological stress response of physiotherapy last year students in his final degree dissertation. Physiology & Behavior, 2020. 222, 112928

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/08/2022
Date of last participant enrolment
Anticipated
8/03/2027
Actual
Date of last data collection
Anticipated
16/07/2027
Actual
Sample size
Target
110
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312992 0
University
Name [1] 312992 0
James Cook University
Country [1] 312992 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive
Townsville
4811
QLD
Country
Australia
Secondary sponsor category [1] 314675 0
None
Name [1] 314675 0
Address [1] 314675 0
Country [1] 314675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312257 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 312257 0
Ethics committee country [1] 312257 0
Australia
Date submitted for ethics approval [1] 312257 0
27/07/2021
Approval date [1] 312257 0
24/08/2021
Ethics approval number [1] 312257 0
H8333

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

Contacts
Principal investigator
Name 124010 0
Dr Carol Ann Flavell
Address 124010 0
Rm 013, building 43
James cook University
Townsville Campus
4811
QLD
Country 124010 0
Australia
Phone 124010 0
+61 747816472
Fax 124010 0
Email 124010 0
carol.flavell@jcu.edu.au
Contact person for public queries
Name 124011 0
Carol Ann Flavell
Address 124011 0
Rm 013, building 43
James cook University
Townsville Campus
4811
QLD
Country 124011 0
Australia
Phone 124011 0
+61 747816472
Fax 124011 0
Email 124011 0
carol.flavell@jcu.edu.au
Contact person for scientific queries
Name 124012 0
Carol Ann Flavell
Address 124012 0
Rm 013, building 43
James cook University
Townsville Campus
4811
QLD
Country 124012 0
Australia
Phone 124012 0
+61 747816472
Fax 124012 0
Email 124012 0
carol.flavell@jcu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not ethically approved to release individual data but anonymised whole study population data can be available upon request from the chief investigator.


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.