Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000834853
Ethics application status
Approved
Date submitted
11/08/2020
Date registered
30/06/2021
Date last updated
30/06/2021
Date data sharing statement initially provided
30/06/2021
Date results information initially provided
30/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A evidence-based study of effects of Zen meditation on the meridian system, heart rate variability (HRV) and emotional status
Scientific title
A evidence-based study of effects of Zen meditation on the meridian system, heart rate variability (HRV) and emotional status in healthy volunteers
Secondary ID [1] 302014 0
RD108015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 318574 0
Condition category
Condition code
Alternative and Complementary Medicine 316587 316587 0 0
Other alternative and complementary medicine
Mental Health 316588 316588 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
an intensive 3-day Zen meditation program:
During meditation sessions in this study, participants were instructed to sit in an upright position, avoid movements, focus on awareness and count breaths. The eyes are closed during the meditation practice. The skills of Zen meditation were instructed by the senior monk who had received training in Taiwan with decades of experience of Zen meditation for more than 20 years. Each seated meditation session was 40 minutes. After every seated session meditation, slow walking meditation for 30 minutes was alternated with awareness of the here and now also. Participants were instructed to avoid using mobile phone, keep awareness and silent during all retreat time, even during meals and any other activity. The activities included in the meditation program composed of 6 cycles of 40 min seated meditation followed by 30 min of slow walking meditation plus 3 silent meals over a 12-hour day.
Intervention code [1] 318305 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324720 0
Meridian system status measurement:
The participants will be rested on a chair for 10 minutes before measurements were recorded. The electrical conductance of 24 acupuncture points in the wrists and ankles of the 12 left and 12 right meridians was measured using a device (MEAD, 6th generation, Medpex Enterprises, Taiwan). The meridians were as follows: lung, (L, H1), pericardium (P, H2), heart (H, H3), small intestine (SI, H4), triple energizer (TE, H5), large intestine (LI, H6), spleen (SP, F1), liver (LIV, F2), kidney (K, F3), urinary bladder (B, F4), gallbladder (G, F5), and stomach (S, F6).
Timepoint [1] 324720 0
before undertaking an intensive Zen meditation program and immediately post-intensive Zen meditation program completion
Secondary outcome [1] 385553 0
heart rate variability (HRV)
Five-minute electrocardiography data were recorded for HRV measurements. Polar heart-rate monitors (Polar Vantage NV, Polar Electro Oy, Finland) were used to continuously collect heart rate data in the form of RR intervals from all participants.
Timepoint [1] 385553 0
before undertaking an intensive Zen meditation program and immediately post-intensive Zen meditation program completion
Secondary outcome [2] 385554 0
Anxiety assessed by State-Trait Anxiety Inventory (STAI)
Timepoint [2] 385554 0
before undertaking an intensive Zen meditation program and immediately post-intensive Zen meditation program completion

Eligibility
Key inclusion criteria
20-70 years old with experience of meditation less than 6 months
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnant women or people with mental disability

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/04/2019
Date of last participant enrolment
Anticipated
Actual
5/05/2019
Date of last data collection
Anticipated
Actual
7/05/2019
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 22824 0
Taiwan, Province Of China
State/province [1] 22824 0

Funding & Sponsors
Funding source category [1] 306434 0
Hospital
Name [1] 306434 0
Show Chwan Memorial Hospital
Country [1] 306434 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Show Chwan Memorial Hospital
Address
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 306950 0
None
Name [1] 306950 0
Address [1] 306950 0
Country [1] 306950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306643 0
Institutional Review Board of Show Chwan Memorial Hospital
Ethics committee address [1] 306643 0
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Ethics committee country [1] 306643 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 306643 0
Approval date [1] 306643 0
27/03/2019
Ethics approval number [1] 306643 0
1080106

Summary
Brief summary
Background: Many observations claimed that Zen meditation was beneficial to human health. However, objective and evidence-based studies were limited. Oriented from ancient Traditional Chinese Medicine (TCM), meridian system is composed of 12 main meridians which closely associated with the acupuncture points and the electrophysiological conductivity of the human body. The meridian theory explained the cause-effect relationships of many of the diseases. In contrast, little is known to the effects of Zen meditation on the meridian system, heart rate variability (HRV) and emotional status.
Objective: This study aims to empirically examine the effects of Zen meditation on the meridian system, HRV and emotional status by undertaking an intensive Zen meditation program.
Methods: This study is a single-arm pretest-posttest design. Participants will be collected about their data on the meridian system, HRV and emotional status before and after undertaking an intensive Zen meditation program. Meridian system status and HRV data will be collected using commercialized devises and anxiety status will be examined by State-Trait Anxiety Inventory (STAI).
Expected outcomes: It is expected to understand more about the effects of Zen meditation on the meridian system, HRV and emotional status by undertaking an intensive Zen meditation program. The results may suggest Zen meditation as one of the health promotion programs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104526 0
Dr Chun-Yi Lin
Address 104526 0
Show Chwan Memorial Hospital, 542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 104526 0
Taiwan, Province Of China
Phone 104526 0
+886 975611183
Fax 104526 0
Email 104526 0
[email protected]
Contact person for public queries
Name 104527 0
Dr Ming-Tsung Lee
Address 104527 0
Show Chwan Memorial Hospital, 542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 104527 0
Taiwan, Province Of China
Phone 104527 0
+886 975611502
Fax 104527 0
Email 104527 0
[email protected]
Contact person for scientific queries
Name 104528 0
Dr Ming-Tsung Lee
Address 104528 0
Show Chwan Memorial Hospital, 542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 104528 0
Taiwan, Province Of China
Phone 104528 0
+886 975611502
Fax 104528 0
Email 104528 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.