ANZCTR - Registration

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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

6/07/2024

Date data sharing statement initially provided

30/06/2023

Type of registration

Retrospectively 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]

None

Universal Trial Number (UTN)

Trial acronym

BEATWCH

Linked study record

Health condition

Health condition(s) or problem(s) studied:

White Coat Hypertension

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Public Health

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]

Behaviour

Comparator / control treatment

None
The blood pressure before the intervention will be taken as control

Control group

Active

Outcomes

Primary outcome [1]

blood pressure measured using automated sphygmomanometer

Timepoint [1]

immediately before and after each intervention

Secondary outcome [1]

Heart rate in beats per minute using automated sphygmomanometer

Timepoint [1]

immediately before and after each intervention

Secondary outcome [2]

Respiratory rate in breaths per minute via manual count by clinician

Timepoint [2]

immediately before and after each intervention

Secondary outcome [3]

Stress via 100mm visual analogue scale

Timepoint [3]

immediately before and after each intervention

Secondary outcome [4]

Nervousness via 100mm visual analogue scale

Timepoint [4]

immediately before and after each intervention

Secondary outcome [5]

Tension via 100mm visual analogue scale

Timepoint [5]

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

Recruiting

Date of first participant enrolment

Anticipated

30/06/2023

Actual

27/06/2023

Date of last participant enrolment

Anticipated

31/12/2024

Actual

Date of last data collection

Anticipated

28/02/2025

Actual

Sample size

Target

12

Accrual to date

1

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment postcode(s) [1]

4006 - Fortitude Valley

Recruitment postcode(s) [2]

4520 - Samford Village

Recruitment postcode(s) [3]

2026 - Bondi

Funding & Sponsors

Funding source category [1]

University

Name [1]

Southern Cross University

Address [1]

Military Rd
East Lismore NSW 2480
Australia

Country [1]

Australia

Primary sponsor type

University

Name

Southern Cross University

Address

Military Rd
East Lismore NSW 2480
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Cross University HREC

Ethics committee address [1]

Southern Cross University
PO Box 157, Lismore NSW 2480

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/04/2023

Approval date [1]

30/04/2023

Ethics approval number [1]

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

A/Prof Romy Lauche

Address

National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia

Country

Australia

Phone

+61 266203362

Fax

Email

romy.lauche@scu.edu.au

Contact person for public queries

Name

Lauren Prictor

Address

National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia

Country

Australia

Phone

+61 266203362

Fax

Email

l.prictor.10@student.scu.edu.au

Contact person for scientific queries

Name

Romy Lauche

Address

National Centre for Naturopathic Medicine
Military Rd
East Lismore NSW 2480
Australia

Country

Australia

Phone

+61 266203362

Fax

Email

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.