Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000652471
Ethics application status
Approved
Date submitted
13/05/2025
Date registered
19/06/2025
Date last updated
19/06/2025
Date data sharing statement initially provided
19/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Brief Breathwork practice on stress via telehealth: feasibility and efficacy of online breathwork for five minutes a day for 30 days
Scientific title
Structured Breathing Practice for Stress via Telehealth: A Feasibility Randomised Controlled Trial among members of the exercise physiology clinic.
Secondary ID [1] 314430 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 337450 0
Anxiety 337451 0
Condition category
Condition code
Mental Health 333825 333825 0 0
Anxiety
Mental Health 334129 334129 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the Breathwork intervention group will receive a thirty day, daily five-minute structured breathing protocol. The breathing practice will be intentional, slow paced, and diaphragmatic, at a respiratory ratio of four seconds inhalation, and six seconds exhalation. There will be no breath holds. Breathing will be instructed to be nostrils only on inhalation and exhalation. Participants will receive this protocol through two instructor-led, small group online sessions per week via Zoom, and complete self-directed practice for the other five days each week. During self-directed practice participants will have access to eXHALeR and an audio-visual guide.

Breathwork Intervention Group

Materials
During self-directed practice participants will have access to a web-based breathing eXHALeR which provides simple audio-visual guide. Participants will be provided a logbook to record their pre and post Visual Analogue Stress Score (VASS) and will require access to internet and a mobile device.

Procedures
Participants allocated to the breathwork intervention group will receive a thirty day, daily five-minute breathwork protocol. The breathwork practice will be intentional, slow paced, and diaphragmatic, at a respiratory ratio of four seconds inhalation, and six seconds exhalation. There will be no breath holds. Breathing will be instructed to be via the nostrils only on inhalation and exhalation. Participants will attend a training session to learn the breathwork protocol and how to access and use the online tools. During the intervention participants will receive two instructor-led, small group online sessions per week via Zoom, and complete self-directed practice for the other five days each week. During self-directed practice participants will have access to eXHALeR and an audio-visual guide.

Who will deliver the intervention?
The lead investigator will deliver the pre intervention training and deliver the instructor led online breathwork sessions.

Mode of delivery.
The breathwork intervention group will participate in online, instructor-led sessions twice a week and self-directed practice five days a week.
duration, intensity
participants will practice the breathwork protocol for five minutes per day, for thirty days.
The breathwork protocol intensity is low at four seconds inhalation and six seconds exhalation at six breaths per minute for five minutes. This breathwork protocol has been demonstrated to be safe, with no adverse events reported in the literature,

Location.
Initial informed consent, baseline assessments, and protocol training sessions will be conducted face to face with an Exercise Physiology clinic. The Breathwork intervention group will be conducted online.

Adherence.
Feasibility will be assessed by recruitment rate (% of eligible participants expressing an interest and providing informed consent for the study), retention (% of commencing participants who remain in the study at baseline, end intervention and follow-up), and adherence (proportion of participants completing on-line and self-directed sessions, completion of daily logbook proportion of eXHALeR app use.)
Intervention code [1] 331057 0
Treatment: Other
Comparator / control treatment
Breathwork Control Group
Why Rationale
The control group will use a spontaneous breathing protocol (5 minutes, 10-12 breaths per minute, no intentional depth or rate changes) commonly used in breathwork studies, as it engages participants in breathwork without inducing the stress-reducing parasympathetic effects of slower breathing (around 6 breaths per minute).

Materials
-Quiet, comfortable space
-Timer or stopwatch (e.g., phone app)
-VAS form in provided logbook (paper)
-Pen or marking VAS scores

Procedures
#1: Preparation (2-3 minutes)
-Find a quiet, distraction-free space. Sit comfortably upright or lie down, ensuring your body is relaxed.
-Review the VAS form. For example, if measuring relaxation, the scale ranges from 0 ("Not at all relaxed") to 5 ("Extremely relaxed").

#2: Set a timer for 5 minutes.
- Pre-Session VAS Scoring (1 minute)
- Before starting the breathing exercise, mark your current state on the VAS form by placing a vertical line on the VAS scale to indicate your level of relaxation

#3: Mindfulness Spontaneous Breathing (5 minutes)
- Close your eyes (optional) and bring attention to your natural breath.
- Breathe spontaneously without intentionally changing the rate or
- Focus mindfully on the sensation of your breath (e.g., air moving through your nostrils or chest rising/falling). If your mind wanders, gently return focus to your breath.
- Continue for 5 minutes, using the timer to signal the end.
#4 Submission (1 minute)
-Record both pre- and post-VAS scores in the provided logbook
- Include any brief notes on your experience (e.g., distractions, ease of focus)

Intervention provider
The breathwork Control group is self-directed practice.

Delivery Mode
Self-Directed

Location
At participant’s home

How often
Daily five-minute practice for thirty days at time of participants choosing

Tailoring
The participant is free to breath in anyway that is natural and spontaneous to them. They are instructed not to apply any intentional change in breathing rate, depth or rhythm.
Control group
Active

Outcomes
Primary outcome [1] 341447 0
Feasibility independent outcome #1: recruitment rate (% of eligible participants expressing an interest and providing informed consent for the study),
Timepoint [1] 341447 0
Baseline, week 4 (end of breathwork intervention), week 8 (follow-up)
Primary outcome [2] 341786 0
Feasibility independent outcome #2: retention (% of commencing participants who remain in the study
Timepoint [2] 341786 0
baseline, end intervention (week 4) and follow-up (week 8)
Primary outcome [3] 341787 0
Feasibility independentt outcome #3: adherence (proportion of participants completing on-line and self-directed sessions)
Timepoint [3] 341787 0
baseline, end of intervention (week 4) and follow-up (week -8)
Secondary outcome [1] 447535 0
Efficacy independent secondary outcome #1: Efficacy of a structured breathing protocol on Acute stress levels, measured as the change in Visual Analogue Stress Scale (VASS) scores from baseline to daily measurements (before and after breathing practice) during the intervention and at follow-up.
Timepoint [1] 447535 0
the Visual Analogue Stress Scale will be taken at baseline, during intervention (before and after each daily breathwork practice). and at follow up.
Secondary outcome [2] 448699 0
Efficacy independent secondary outcome #2:Efficacy of a structured breathing protocol on chronic stress levels, measured as the change in Perceived Stress Questionnaire (PSQ) scores from baseline, end of interventions and follow-up.
Timepoint [2] 448699 0
Baseline, end of intervention (week 4) and at follow-up (week 8)

Eligibility
Key inclusion criteria
To be eligible to participate, clients will need to be healthy adults with access to the internet and ownership of a smartphone will also be required. They will also need to be members /clients of the exercise physiology clinic Balance Holistic Fitness. Clinic clients expressing an interest in the study will have already been screened by an exercise physiologist and attained relevant medical clearance for exercise.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
exclusion criteria including cardiac conditions such as a major adverse cardiac event, severe COPD, and severe mental health conditions (Bipolar disorder, schizophrenia, or recent hospitalization for psychiatric issues.)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Feasibility data will be reported descriptively. Comparisons between the proportions of participants in each group meeting a priori adherence criteria (determined from a review of the literature of similar studies in the area) will be evaluated using chi-square tests. ( “A priori criteria defined as equal to or greater than 80% completion of all study assessments, based on literature benchmarks.”)

Between group comparisons for the efficacy outcomes of stress will be compared using ANCOVA analysis, with the baseline data entered as the co-variate, to compare change values across time between the intervention and control groups. A significance level of P<.05 will be used for all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 44138 0
2536 - Batehaven

Funding & Sponsors
Funding source category [1] 318958 0
University
Name [1] 318958 0
University of Queensland
Country [1] 318958 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 321426 0
None
Name [1] 321426 0
Address [1] 321426 0
Country [1] 321426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317568 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 317568 0
Ethics committee country [1] 317568 0
Australia
Date submitted for ethics approval [1] 317568 0
13/02/2025
Approval date [1] 317568 0
28/04/2025
Ethics approval number [1] 317568 0
2024/HE002246

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

Contacts
Principal investigator
Name 141454 0
A/Prof Nicholas Gilson
Address 141454 0
School of Human Movement and Nutrition Sciences The University of Queensland Brisbane Qld 4072 Australia
Country 141454 0
Australia
Phone 141454 0
+61 7 3365 6114
Fax 141454 0
Email 141454 0
[email protected]
Contact person for public queries
Name 141455 0
Andrew Dowler
Address 141455 0
School of Human Movement and Nutrition Sciences The University of Queensland Brisbane Qld 4072 Australia
Country 141455 0
Australia
Phone 141455 0
+61419874682
Fax 141455 0
Email 141455 0
[email protected]
Contact person for scientific queries
Name 141456 0
Andrew Dowler
Address 141456 0
School of Human Movement and Nutrition Sciences The University of Queensland Brisbane Qld 4072 Australia
Country 141456 0
Australia
Phone 141456 0
+61419874682
Fax 141456 0
Email 141456 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• please contact [email protected]

Are there extra considerations when requesting access to 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.