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Trial registered on ANZCTR


Registration number
ACTRN12618000302257
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
28/02/2018
Date last updated
23/08/2019
Date data sharing statement initially provided
23/08/2019
Date results information initially provided
23/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Perceived levels of stress and anxiety and their impact on performance of physiotherapy students during clinical placements.
Scientific title
Perceived levels of stress and anxiety and their impact on performance of physiotherapy students during clinical placements.
Secondary ID [1] 294091 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 306670 0
Anxiety 306671 0
Condition category
Condition code
Mental Health 305769 305769 0 0
Anxiety
Mental Health 305882 305882 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to measure and identify levels of stress and anxiety perceived by physiotherapy students during clinical placements. It aims to identify whether there are any factors that influence students’ perceived levels of stress and anxiety, whilst observing the presence of a relationship to academic outcomes or levels of personal resilience. Stress and anxiety will be measured prior to and at weekly intervals for the 5 week duration of clinical placements.
Intervention code [1] 300370 0
Not applicable
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304841 0
Change in levels of stress over the 5 week placement measured using a visual analogue scale where 0 = no stress and 100 = extremely severe stress.
Timepoint [1] 304841 0
At weekly intervals for the 5 week duration of clinical placement with week 5 being the primary timepoint..
Primary outcome [2] 304842 0
Change in levels of anxiety over the 5 week placement measured using a visual analogue scale where 0 = no anxiety and 100 = extremely severe anxiety.
Timepoint [2] 304842 0
At weekly intervals for the 5 week duration of clinical placement with week 5 being the primary timepoint..
Secondary outcome [1] 343340 0
Correlation between initial anxiety traits (measured using the Trait portion of the State-Trait Anxiety Inventory) and mean anxiety over the 5 week placement period..
Timepoint [1] 343340 0
At the completion of the 5 week placement period.

Eligibility
Key inclusion criteria
This study will recruit physiotherapy students (both undergraduate and graduate entry) from the University of South Australia who are undertaking their acute care, rehabilitation or primary and ambulatory care clinical placements at Central Adelaide Local Health Network sites during their physiotherapy studies in 2018. Participants may be recruited to the study on more than one occasion if eligibility criteria are met (as students may complete one, two or all three of these clinical placements at Central Adelaide Local Health Network sites). Therefore, any one student may be recruited on up to three occasions.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwilling to participate.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data will be imported into SPSS (SPSS Inc., Chicago, IL, USA , v17.0) for analyses which will be predominantly descriptive in nature. Data will be assessed for normal distribution and parametric/non-parametric tests used accordingly. Participant ratings (Visual Analogue Scale) of perceived stress and anxiety while on clinical placement will be explored descriptively and compared across the time points. Additional analyses will be undertaken to investigate whether perceived stress and anxiety levels impacted on clinical and/or academic performance. Data from open-ended questions will be thematically analysed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10062 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 10063 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 10064 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 21579 0
5000 - Adelaide
Recruitment postcode(s) [2] 21580 0
5011 - Woodville
Recruitment postcode(s) [3] 21581 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 298723 0
Hospital
Name [1] 298723 0
Alison Kinsman AM Physiotherapy Research Grant, Royal Adelaide Hospital
Address [1] 298723 0
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country [1] 298723 0
Australia
Primary sponsor type
Individual
Name
Deborah Gallasch
Address
8G-140
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 297895 0
Individual
Name [1] 297895 0
Amy Conlon-Leard
Address [1] 297895 0
Physiotherapy Department
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
Adelaide
South Australia 5011
Country [1] 297895 0
Australia
Secondary sponsor category [2] 297896 0
Individual
Name [2] 297896 0
Kathy Stiller
Address [2] 297896 0
7F-060
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000



Country [2] 297896 0
Australia
Secondary sponsor category [3] 297897 0
Individual
Name [3] 297897 0
Michelle Hardy
Address [3] 297897 0
Physiotherapy Department
Hampstead Rehabilitation Hospital
Hampstead Road
Northfield
Adelaide
South Australia 5085
Country [3] 297897 0
Australia
Other collaborator category [1] 279941 0
University
Name [1] 279941 0
University of South Australia
Address [1] 279941 0
School of Health Sciences
University of South Australia
North Terrace
Adelaide
South Australia 5000
Country [1] 279941 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299668 0
Central Adelaide Local Health Network Research Ethics Committee
Ethics committee address [1] 299668 0
Level 3 Roma Mitchell House
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 299668 0
Australia
Date submitted for ethics approval [1] 299668 0
02/02/2018
Approval date [1] 299668 0
02/02/2018
Ethics approval number [1] 299668 0
HREC/18/CALHN/74
Ethics committee name [2] 299669 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 299669 0
North Terrace
Adelaide
South Australia 5000
Ethics committee country [2] 299669 0
Australia
Date submitted for ethics approval [2] 299669 0
08/02/2018
Approval date [2] 299669 0
14/02/2018
Ethics approval number [2] 299669 0
200997

Summary
Brief summary
The main purpose of this study is to explore the levels of stress and anxiety perceived by physiotherapy students during the course of their clinical placements. Clinical placements are designed to challenge students’ learning and expose them to situations which they would not otherwise experience. The transition between university-based learning and clinical practice is challenging for many students. Developing competency in safe patient management in the clinical setting is demanding, with a noticeable gap between what is learnt in the classroom and implementing this in a clinical setting. Supervised clinical placements provide experiential learning where students gain concrete experience, and have opportunities for observation and reflection, formation of abstract concepts and practise of new skills. In our anecdotal experience, a high number of physiotherapy students report that clinical placements are a source of stress and anxiety. It is the amount of stress and an individual student’s capacity to manage it that can result in stress being either beneficial or detrimental to learning. It is currently unknown whether the perceived levels of stress and anxiety that physiotherapy students experience during clinical placement impacts on their learning, either positively or negatively, and what factors may contribute to this.
The primary aim of this study is to measure the levels of stress and anxiety perceived by physiotherapy students at a number of time points across their clinical placements (acute care, rehabilitation and primary and ambulatory care) to determine if the students’ perceived levels of stress and anxiety change over the clinical placement.
Secondary aims include whether any patterns emerge in the levels of stress and anxiety perceived by students and whether baseline measures of anxiety traits influence anxiety levels during clinical placements.
It is anticipated that the study will provide insight into the levels of stress and anxiety perceived by physiotherapy students during their clinical placements. It is possible that patterns of perceived stress and anxiety may emerge during particular time points in the clinical placement which could be used to help inform future research and to guide time specific changes to the clinical placement framework (e.g. strategies for stress reduction, education around resilience) which in turn may enhance clinical placement experiences and optimise student learning
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81234 0
Ms Deborah Gallasch
Address 81234 0
8G-140
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country 81234 0
Australia
Phone 81234 0
+61 8 70742850
Fax 81234 0
Email 81234 0
Deborah.Gallasch@sa.gov.au
Contact person for public queries
Name 81235 0
Ms Deborah Gallasch
Address 81235 0
8G-140
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country 81235 0
Australia
Phone 81235 0
+61 8 70742850
Fax 81235 0
Email 81235 0
Deborah.Gallasch@sa.gov.au
Contact person for scientific queries
Name 81236 0
Dr Kathy Stiller
Address 81236 0
7F-060
Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country 81236 0
Australia
Phone 81236 0
+61 8 870742639
Fax 81236 0
Email 81236 0
Kathy.Stiller@sa.gov.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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary