Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000815460p
Ethics application status
Not yet submitted
Date submitted
4/07/2025
Date registered
30/07/2025
Date last updated
30/07/2025
Date data sharing statement initially provided
30/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness-based training for healthcare professionals in an acute care setting.
Scientific title
Effect of mindfulness-based training on heart rate variability among healthcare professionals in an acute care setting.
Secondary ID [1] 315020 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart rate variability 337908 0
Stress 337909 0
Condition category
Condition code
Mental Health 334236 334236 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mindfulness-based intervention (MBI) consists of four daily activities to foster mindful awareness, including abdominal breathing, speaking from the stomach, thinking from the spine, and pausing before acting.
The intervention will consist of one x one-hour mindfulness training session each week for two weeks.
The mode of administration will be provided through group or one-to-one sessions (depending on participants' availability and preference)
Monitoring intervention adherence will be captured on participant questionnaires during the data collection process.
Daily mindfulness activities will be practiced for approximately 5 minutes at the start of each day over a period of 3 weeks.

Speaking from the Stomach
One way of maintaining a low tension level is by speaking from the stomach. Participants will be introduced to a vocal relaxation practice, encouraging speech from the diaphragm and abdomen to promote relaxation and self-awareness. The aim is to foster awareness of the connection between cognitive focus, bodily tension, and vocalisation, supporting greater self-regulation and well-being.

Thinking from the spine
This process involves guiding participants through three distinct modes of cognitive awareness, each correlated with physical tension. First, individuals focus on their forehead, producing noticeable tension in the scalp and brow, commonly linked with anxiety or stress. Second, attention shifts to the back of the head, resulting in a more relaxed and diffuse awareness. Third, awareness extends along the spine, encouraging whole-body relaxation, minimal tension, and a state of self-awareness. Throughout the process, participants are guided to observe and compare bodily sensations and tension levels associated with each mode of thinking.

The training will be delivered face-to-face; participants will also receive a handout outlining the practices to take home.

Daily mindfulness activities will commence after the first training session.
Intervention code [1] 331322 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342170 0
Change in heart rate variability (HRV) metrics from baseline to post-intervention
Timepoint [1] 342170 0
Baseline and post-intervention (3 weeks post-baseline data collection)
Secondary outcome [1] 449806 0
Change in self-reported comfort levels
Timepoint [1] 449806 0
Baseline and post-intervention (3 weeks post-baseline data collection)

Eligibility
Key inclusion criteria
• Healthcare professionals
• Currently employed in an acute care setting
• Give informed consent
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of cardiovascular disease, i.e. hypertension, atrial fibrillation,
• Taking any medication known to influence heart rate.
• Agency staff

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2025
Actual
Date of last participant enrolment
Anticipated
29/09/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 27133 0
New Zealand
State/province [1] 27133 0

Funding & Sponsors
Funding source category [1] 319266 0
University
Name [1] 319266 0
Te Herenga Waka - Victoria University of Wellington
Country [1] 319266 0
New Zealand
Primary sponsor type
University
Name
Te Herenga Waka - Victoria University of Wellington
Address
Country
New Zealand
Secondary sponsor category [1] 321741 0
None
Name [1] 321741 0
Address [1] 321741 0
Country [1] 321741 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317844 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317844 0
Ethics committee country [1] 317844 0
New Zealand
Date submitted for ethics approval [1] 317844 0
11/08/2025
Approval date [1] 317844 0
Ethics approval number [1] 317844 0

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

Contacts
Principal investigator
Name 142330 0
Ms Janine Dewar
Address 142330 0
Room 702, Level 7, Clinical Services Block, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington 6021, New Zealand
Country 142330 0
New Zealand
Phone 142330 0
+64 0220665598
Fax 142330 0
Email 142330 0
[email protected]
Contact person for public queries
Name 142331 0
Janine Dewar
Address 142331 0
Room 702, Level 7, Clinical Services Block, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington 6021, New Zealand
Country 142331 0
New Zealand
Phone 142331 0
+64 0220665598
Fax 142331 0
Email 142331 0
[email protected]
Contact person for scientific queries
Name 142332 0
Janine Dewar
Address 142332 0
Room 702, Level 7, Clinical Services Block, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington 6021, New Zealand
Country 142332 0
New Zealand
Phone 142332 0
+64 0220665598
Fax 142332 0
Email 142332 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.