Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000703606
Ethics application status
Approved
Date submitted
13/06/2023
Date registered
30/06/2023
Date last updated
30/06/2023
Date data sharing statement initially provided
30/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Meditation for White Coat Hypertension
Scientific title
Blood Pressure Evaluation of Australian Adults with White Coat Hypertension – Effects of Meditation-based Interventions
Secondary ID [1] 309889 0
None
Universal Trial Number (UTN)
Trial acronym
BEATWCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
White Coat Hypertension 330353 0
Condition category
Condition code
Cardiovascular 327196 327196 0 0
Other cardiovascular diseases
Public Health 327248 327248 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive all interventions in a random order.
All interventions occur only once per participant, with a week between interventions. The interventions will take place after an initial blood pressure reading, and will be followed by another blood pressure reading after the intervention. Each intervention will be administered by the clinician GP, who will also monitor adherence.
1) Mantra chant: while sitting, taking deep breaths, on the third exhale humming the sound OM, 30 seconds in total
2) Chair-based yoga stretch: Chair Warrior and Spinal Twist, 30 seconds in total
3) Breathing exercise: Double inhale & extended exhale technique, 30 seconds in total
Intervention code [1] 326312 0
Behaviour
Comparator / control treatment
None
The blood pressure before the intervention will be taken as control
Control group
Active

Outcomes
Primary outcome [1] 335072 0
blood pressure measured using automated sphygmomanometer
Timepoint [1] 335072 0
immediately before and after each intervention
Secondary outcome [1] 422920 0
Heart rate in beats per minute using automated sphygmomanometer
Timepoint [1] 422920 0
immediately before and after each intervention
Secondary outcome [2] 422921 0
Respiratory rate in breaths per minute via manual count by clinician
Timepoint [2] 422921 0
immediately before and after each intervention
Secondary outcome [3] 422922 0
Stress via 100mm visual analogue scale
Timepoint [3] 422922 0
immediately before and after each intervention
Secondary outcome [4] 422923 0
Nervousness via 100mm visual analogue scale
Timepoint [4] 422923 0
immediately before and after each intervention
Secondary outcome [5] 422924 0
Tension via 100mm visual analogue scale
Timepoint [5] 422924 0
immediately before and after each intervention

Eligibility
Key inclusion criteria
- Generally healthy
- 25 and 65 years of age
- confirmed white coat hypertension within the past 6 months
- BMI between 18.5 and 35 kg/m2
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy or breastfeeding
- Current use of blood pressure lowering medication, including natural products
- Use of psychotropics, with the exception of stable medication for at least 6 months
- Smoking, high-risk alcohol consumption, or use of illicit drugs
- Conditions that prohibit the wearing of a blood pressure monitor such as skin conditions (e.g., eczema, psoriasis), arm injuries or surgeries (incl. recent vaccinations), peripheral artery disease, or neurological conditions (e.g., tremor, paresis, movement disorders), or thoracic outlet syndrome

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 will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Via SealedEnvelope.com
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All participants receive all interventions in randomised order
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 40547 0
4006 - Fortitude Valley
Recruitment postcode(s) [2] 40548 0
4520 - Samford Village

Funding & Sponsors
Funding source category [1] 314073 0
University
Name [1] 314073 0
Southern Cross University
Country [1] 314073 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Military Rd
East Lismore NSW 2480
Australia
Country
Australia
Secondary sponsor category [1] 315983 0
None
Name [1] 315983 0
Address [1] 315983 0
Country [1] 315983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313213 0
Southern Cross University HREC
Ethics committee address [1] 313213 0
Southern Cross University
PO Box 157, Lismore NSW 2480
Ethics committee country [1] 313213 0
Australia
Date submitted for ethics approval [1] 313213 0
26/04/2023
Approval date [1] 313213 0
30/04/2023
Ethics approval number [1] 313213 0
2023/058

Summary
Brief summary
White coat hypertension is when a person's blood pressure readings are too high in a medical setting, like a doctor's office, but are normal elsewhere, like in your home. This condition has been considered not malignant in the past, but recent research has shown that it should be a cause for concern due to poor long-term health outcomes which may require further monitoring or treatment.
Mindfulness interventions, like specific breathing techniques, have been shown to lower blood pressure in adults with essential hypertension. The techniques, however, have not been tested for white coat hypertension, and in addition, have only been found to work if used for weeks.
Therefore, this study aims to explore whether 30-second mindfulness interventions like a mantra chant, a yoga pose, or a breathing exercise can lower blood pressure readings in Australian adults with white coat hypertension.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127362 0
A/Prof Romy Lauche
Address 127362 0
National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia
Country 127362 0
Australia
Phone 127362 0
+61 266203362
Fax 127362 0
Email 127362 0
romy.lauche@scu.edu.au
Contact person for public queries
Name 127363 0
Dr Lauren Prictor
Address 127363 0
National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia
Country 127363 0
Australia
Phone 127363 0
+61 266203362
Fax 127363 0
Email 127363 0
l.prictor.10@student.scu.edu.au
Contact person for scientific queries
Name 127364 0
A/Prof Romy Lauche
Address 127364 0
National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia
Country 127364 0
Australia
Phone 127364 0
+61 266203362
Fax 127364 0
Email 127364 0
romy.lauche@scu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will not be shared as it is not approved according to the protocol submitted to HREC


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.