Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000607572
Ethics application status
Approved
Date submitted
29/04/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a brief biofeedback exercise minimise the impact of acute stress on gastric function?
Scientific title
Does HRV Biofeedback minimise the impact of acute stress on gastric activity? An investigation using the Cold Pressor Test and Body Surface Gastric Mapping.
Secondary ID [1] 311967 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disorders of Gut-Brain Interaction 333648 0
Functional Gastrointestinal Disorders 333709 0
Condition category
Condition code
Oral and Gastrointestinal 330337 330337 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 330390 330390 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be required to attend a single 90-minute session at Alimetry Ltd. The study involves a simple test, "like an ECT for the gut" that will run continuously for the duration of the session. Individuals will also have additional cutaneous electrodes and sensors placed on their hand and shoulders to capture heart rate variability, breath rate, temperature and perspiration. Recording for HRV and associated parameters will run continuously for the duration of the session. This process is painless and non-invasive, although participants are asked to minimise movement.

Participants will be asked to fast (not eat or drink anything including tea and coffee) from midnight the evening prior to their session and asked not to smoke or vape in the morning of their test. They may also be asked to refrain from taking some medications for 48 hours before their test. These medications include: drugs that affect gastric emptying (metoclopramide, domperidone, erythromycin), antispasmodics, pain medications which contain opiates (codeine, oxynorm, morphine, and tramadol), or sedatives. This is because these medications affect normal stomach actions.

Upon arrival, eligibility will be reviewed and confirmed. Participants will be asked if they have any questions or concerns about the studies. Once these are satisfied, they will be required to sign an informed consent form and randomly assigned to either the intervention group (HRVB) or control group (sham procedure)

The Body Surface Gastric Mapping (BSGM) recording will then be set-up:
--A guide will be used to locate the array in a personalised manner. A portable ultrasound may be used to verify this positioning system is accurate.
--Excess hair will be removed and participant’s skin will be prepped using NuPrep, which reduces skin impedance for enhanced test results.
--A 64-channel electrode array (28 cm x 17 cm) will be non-invasively placed over the abdominal skin and connected to a portable data logger.

The HRV Biofeedback equipment will also be set-up.
- A respiratory belt will be placed firmly above the midline of the chest to measure breath rate.
- An ECG electrode will be placed on each shoulder to capture heart rate variability. .
- A PPG will be connected to the middle finger of the left hand for heart rate and blood pressure.
- A temperature probe will be attached to the left thumb to measure temperature.
- Skin conductors will be attached to the index and ring finger of the left hand to measure perspiration.

Around 10 minutes of baseline BSGM and HRV data will be captured. During this time participants will complete standard participant information (e.g. demographics) and the Alimetry Gut-Brain Wellbeing Survey. A baseline measurement of how stressed and relaxed the participant feels will also be recording using a visual analogue sale (VAS).

Participants will then be asked to consume a standardised meal of 425kCal. This includes a nutritional shake and protein bar. Suitable dietary options will be available for diabetics, people with dairy or gluten sensitivities, or people who are vegan. A 10-minute window is provided for meal consumption and participants will be asked to use this full time.

Once the meal has been consumed, participants will then be guided through HRVB training (the intervention) or sham procedure for approximately 20-minutes.

HRVB Training - involves determining resonance frequency (RF) for the individual which typically falls between 4.5 breaths per minute (bpm) and 7 bpm.
- Participants are directed to view their real-time HRV signal (and other parameters as outlined above) on the screen.
- They will see a tracking ball following the curves of a sine wave. They will then be asked to breath in as the ball ascends and breath out as the ball descends.
- To determine optimal RF, participants will engage in breathing at different rates beginning at 5.5 bpm and ranging from 5 to 6.5 bpm
- The researcher and participant will discuss which rate is the most comfortable that produces the highest respiratory sinus arrhythmia (RSA).
- Once RF has been determined, there will be a 10-minute wash-out period.

The Cold Pressor Test
- After the 10-minute wash-out period, participants will be asked to engage in HRVB or the sham procedure for the following 20 to 25 minutes. This will be the same condition they were orignally asssined to.
- Within the first 10 minutes, they will be asked to indicate how relaxed and stressed they feel using a visual analogue scale (VAS)
- At 10-minutes, they will be asked to immerse their right hand fully into a cold bath of approximately 10 degrees Celsius. They will be directed to hold it there for at least 1 minute and then are able to extract their hand thereafter with a ceiling time of 3-minutes observed. During this time pain intensity will be measured using a numerical rating scale (NRS). A third VAS will also be administered when the hand is extracted from thd cold bath.

Post-Cold Pressor Test
- Participants will be asked to continue with the initial treatment they were assigned to (either HRVB or sham procedure) for a further 10-minutes after the cold-pressor test.

Additional note:
The researcher(s) are present for the duration of the observation period to monitor process and adherence to intervention. .
Intervention code [1] 328489 0
Treatment: Other
Comparator / control treatment
Active control group will participate in a sham procedure.
Participants in the sham procedure will be shown a display of their real-time HRV signals and associated parameters, similar to that of HRV Biofeedback intervention. They will be provided with a brief overview of what is being displayed on the screen, however the breathing pacer will not be visible and resonance frequency breathing will not be trialed or followed. Participants will be advised that the biofeedback exercise involves them viewing their real-time signals, while continuing to breathe normally. They will be instructed to ignore changes in signals that may/may not occur for the duration of the observation. Aside from the biofeedback exercise itself, the sequence of tasks are an exact replica of those undertaken by the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 338101 0
Expected alterations in gastric myoelectrical activity for both the intervention group (HRV BIofeedback) and control group (sham procedure).
Timepoint [1] 338101 0
Five time point periods:
(1) at baseline for a 10-minute period;
(2) during 20-minute initiation phase of HRV Biofeedback or Sham Procedure before exposure to the stressor;
(3) during 10-minute washout period following initiation phase.
(4) during the cold pressor test for up to 3 minutes, and
(5) 10-minute period after cold pressor test.
Secondary outcome [1] 434523 0
Explore subjective experience across both conditions for the duration of the observation:
How stressed they feel.
Timepoint [1] 434523 0
Timepoints of interest are outlined below:
1. At the beginning of the baseline period
2. At the end of the initial 10-minute HRV Biofeedback/Sham Procedure, BEFORE Cold Pressor Test.
3. At the end of the Cold Pressor Test, when participant extracts hand voluntarily (up to 3-minutes after initiation of Cold Pressor Test).
4. Participants are asked to continue HRV Biofeedback or sham procedure for 10-minutes after Cold Pressor Test. The level of stress will be measured again at the end of that 10-minutes.
Secondary outcome [2] 434524 0
Explore subjective experience across both conditions for the duration of the observation:
How relaxed they feel.
Timepoint [2] 434524 0
Timepoints of interest are outlined below:
1. At the beginning of the baseline period
2. At the end of the initial 10-minute HRV Biofeedback/Sham Procedure. BEFORE Cold Pressor Test.
3. At the end of the Cold Pressor Test, when participant extracts hand voluntarily (up to 3-minutes after initiation of Cold Pressor Test.
4. Participants are asked to continue HRV Biofeedback or sham procedure for 10-minutes after Cold Pressor Test. The level of stress will be measured at the end of that 10-minutes.
Secondary outcome [3] 434525 0
To measure pain intensity of participants when exposed to cold pressor test.
Timepoint [3] 434525 0
Three time points of interest:
1. When hand is immersed into the cold pressor test.
2. When hand has been in the cold pressor test for 1 minute.
3. When participant extracts hand from cold pressor test.
Secondary outcome [4] 434722 0
To examine fluctuations in HRV across both conditions.
Timepoint [4] 434722 0
Five time point periods:
(1) at baseline for a 10-minute period;
(2) during 20-minute initiation phase of HRV Biofeedback or Sham Procedure before exposure to the stressor;
(3) during 10-minute wash-out period after initiation phase.
(4) during the cold pressor test for up to 3 minutes, and
(5) 10-minute period after cold pressor test.

Eligibility
Key inclusion criteria
18+ years of age.
Fluent in English.
Are able to fully understand the risks and benefits of the research and provide informed consent.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with a history of chronic gastrointestinal (GI) disorders or GI surgeries.
Individuals who are pregnant or lactating.
Individuals who are allergic to adhesives, extremely sensitive to cosmetic lotions, susceptible to bruises or skin tears.
Individuals who have existing abdominal abrasions.
Individuals who are unable to sit comfortably in a supine position for the duration of observation.

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 concealment using opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomizer.org
Randomisation completed by another researcher.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
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
4/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 26286 0
New Zealand
State/province [1] 26286 0
Auckland

Funding & Sponsors
Funding source category [1] 316313 0
University
Name [1] 316313 0
University of Auckland
Country [1] 316313 0
New Zealand
Funding source category [2] 316403 0
Commercial sector/Industry
Name [2] 316403 0
Alimetry Ltd
Country [2] 316403 0
New Zealand
Primary sponsor type
University
Name
University of Auckland, Department of Psychological Medicine
Address
Country
New Zealand
Secondary sponsor category [1] 318495 0
None
Name [1] 318495 0
Address [1] 318495 0
Country [1] 318495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315127 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315127 0
Ethics committee country [1] 315127 0
New Zealand
Date submitted for ethics approval [1] 315127 0
06/03/2024
Approval date [1] 315127 0
22/04/2024
Ethics approval number [1] 315127 0
19494

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

Contacts
Principal investigator
Name 133750 0
Dr Elizabeth Broadbent
Address 133750 0
University of Auckland, Department of Psychological Medicine, FMHS Building 507, 28 Park Avenue, Grafton, Auckland, New Zealand
Country 133750 0
New Zealand
Phone 133750 0
+64 93737599
Fax 133750 0
Email 133750 0
[email protected]
Contact person for public queries
Name 133751 0
Elizabeth Broadbent
Address 133751 0
University of Auckland, Department of Psychological Medicine, FMHS Building 507, 28 Park Avenue, Grafton, Auckland, New Zealand
Country 133751 0
New Zealand
Phone 133751 0
+64 93737599
Fax 133751 0
Email 133751 0
[email protected]
Contact person for scientific queries
Name 133752 0
Elizabeth Broadbent
Address 133752 0
University of Auckland, Department of Psychological Medicine, FMHS Building 507, 28 Park Avenue, Grafton, Auckland, New Zealand
Country 133752 0
New Zealand
Phone 133752 0
+64 93737599
Fax 133752 0
Email 133752 0
[email protected]

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 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.