Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000417482
Ethics application status
Approved
Date submitted
17/04/2025
Date registered
7/05/2025
Date last updated
7/05/2025
Date data sharing statement initially provided
7/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of compassion training on Ambulance Victoria paramedics on levels of compassion and burnout.
Scientific title
Effectiveness of compassion training on paramedics: A randomized controlled trial
Secondary ID [1] 314238 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resilience 337154 0
Depression 337153 0
Burnout 337150 0
Compassion 337151 0
Anxiety 337152 0
Stress 337155 0
Condition category
Condition code
Mental Health 333571 333571 0 0
Depression
Mental Health 333692 333692 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 333691 333691 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paramedics will undertake the Monash University 'Compassion Training for Healthcare Workers' course. They will be randomly assigned to 2 courses which will run consecutively. The course is an online 4-week, self-paced course with 4 hours of core content and up to 12 hours of engagement, completed over 8 weeks.
Each week of the course contains written material, videos, practical exercises, research articles, weekly feedback video, optional online discussion forums and a live Q & A event with the course facilitators.
Core topics are:
Week 1 Introducing compassion: Includes content on science of compassion; how to transform empathy into compassion to avoid empathic distress; exercise on receiving and giving compassion; compassion practice record.
Week 2 Barriers to compassion: Includes content on why compassion can be easily disrupted; reasons for not getting to compassion; mindfulness in healthcare; exercise on letting go after the interaction; caring for self and caring for others.
Week 3 Common humanity: Includes content on the importance of common humanity; five moments of compassion; forgiveness, gratitude and wellbeing; perspectives that help us relate to others more positively; social connectedness; creating compassionate workplaces.
Week 4 Sustaining compassion: Includes content on compassion in daily life; tips to help sustain compassion; values, ethics and intention; course summary; live Q & A zoom.
The purpose of the optional discussion forums is to allow participants the opportunity to share their reflections on learnings on core topics with others and also to ask questions of the course facilitators if they wish to. Discussion forums are placed against key topics.
An example of an optional discussion forum is "Now you have an understanding of the difference between compassion and empathic distress, notice throughout the week how often you are going into compassion or empathic distress when confronted with another's suffering. Share reflections on this exercise.
Optional material is against core topics and provides additional information e.g. links to research articles, to podcasts or relevant websites.
Participants will anonymously complete a selection of surveys measuring levels of burnout, compassion, depression and resilience on 3 separate occasions, both before and after they take the course. Participants can also opt in to a 1 on 1 interview conducted 2-4 weeks after completing the course to discuss their thoughts on the compassion training course.
Intervention code [1] 330851 0
Prevention
Comparator / control treatment
The participants enrolled in the second course will act as a waitlist control group. All participants will complete a survey prior to the first group beginning the course. All participants will complete another survey 8 weeks later, when the first group has completed the course but before the second group has started the course. This will provide survey results for the first (treatment) group who have taken the course and the second (control) group who have not yet taken the course.
Control group
Active

Outcomes
Primary outcome [1] 341147 0
Compassion
Timepoint [1] 341147 0
First (treatment) group - Prior to course, at course completion (primary timepoint), 8 weeks later. Second (control) group - 8 weeks prior to course, immediately prior to course (primary timepoint), at completion of course.
Primary outcome [2] 341148 0
Depression
Timepoint [2] 341148 0
First (treatment) group - Prior to course, at course completion (primary timepoint), 8 weeks later. Second (control) group - 8 weeks prior to course, immediately prior to course (primary timepoint), at completion of course.
Primary outcome [3] 341146 0
Burnout
Timepoint [3] 341146 0
First (treatment) group - Prior to course, at course completion (primary timepoint), 8 weeks later. Second (control) group - 8 weeks prior to course, immediately prior to course (primary timepoint), at completion of course.
Secondary outcome [1] 446504 0
Resilience (primary outcome)
Timepoint [1] 446504 0
First (treatment) group - Prior to course, at course completion (primary timepoint), 8 weeks later. Second (control) group - 8 weeks prior to course, immediately prior to course (primary timepoint), at completion of course.

Eligibility
Key inclusion criteria
Paramedics who work at Ambulance Victoria and are doing some clinical work
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nurses who work in phone and telehealth.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, allocation involves contacting the holder of the allocation schedule who is "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator, 50:50 allocation ratio
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
9/06/2025
Actual
Date of last data collection
Anticipated
29/09/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318755 0
Commercial sector/Industry
Name [1] 318755 0
Risk management funding from DXC Technology
Country [1] 318755 0
United States of America
Funding source category [2] 318761 0
University
Name [2] 318761 0
Monash University grant
Country [2] 318761 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321196 0
Government body
Name [1] 321196 0
Ambulance Victoria
Address [1] 321196 0
Country [1] 321196 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317369 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 317369 0
Ethics committee country [1] 317369 0
Australia
Date submitted for ethics approval [1] 317369 0
04/04/2025
Approval date [1] 317369 0
07/04/2025
Ethics approval number [1] 317369 0

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

Contacts
Principal investigator
Name 140834 0
Dr Debbie Ling
Address 140834 0
Monash University, Level 4, Building C, 900 East Caulfield, Vic, 3145
Country 140834 0
Australia
Phone 140834 0
+61 3 9903 4784
Fax 140834 0
Email 140834 0
[email protected]
Contact person for public queries
Name 140835 0
Tamara Johnson
Address 140835 0
Monash University, Level 4, Building C, 900 East Caulfield, Vic, 3145
Country 140835 0
Australia
Phone 140835 0
+61 421231694
Fax 140835 0
Email 140835 0
[email protected]
Contact person for scientific queries
Name 140836 0
Tamara Johnson
Address 140836 0
Monash University, Level 4, Building C, 900 East Caulfield, Vic, 3145
Country 140836 0
Australia
Phone 140836 0
+61 421231694
Fax 140836 0
Email 140836 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The raw data is highly confidential information from an external organisation and we don't feel comfortable to ask Ambulance Victoria to give us permission to share the raw data. The sample is too small and we are concerned about inadvertent identification of respondents.



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.