Comparison of the Effectiveness of Interventions Based on the Eastern Mind-Body Approach on Cardiovascular Responses and Stress Reduction in prehypertensive Subjects.
Reduces high blood pressure and stress in prehypertensive people
Design
The study samples consisted of 120 prehypertensive males and females selected by purposive sampling according to inclusion and exclusion criteria and were randomly assigned into 8 parellel groups of 15 individuals.
Settings and conduct
The study population included all prehypertensive males and females in Tabriz city in 2020. At first, cardiovascular responses will measure by digital wrist sphygmomanometer. Next, subjects will assigne into 4 experimental and control groups. Then, Mental Pressure Inventory will completed and cardiovascular responses recorded as a pre-test. In the next step, Tai Chi Chuan, yoga, and meditation will be performed for one 30-minute session per week, for a total of 10 weeks, and 24 hours after the end of the course, the dependent variables will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- systolic blood pressure 120 to 139 mmHg, and diastolic blood pressure 80 to 89mmHg 2- Age between 25 to 54 years 3- Adequate literacy for reading and writing 4- Ability to attend the sessions.
Exclusion criteria: 1- Sensory-motor disabilities 2- Use of anxiolytic drugs 3- Participation in other treatment sessions simultaneously.
Intervention groups
Tai Chi Chuan: A set of slow, rhythmic, and stretching movements of different parts of the body with deep breathing to achieve physical health and balance of mind and body.
Yoga: Ancient Indian practice aimed at balancing the mind and body.
Meditation: Repetitive cycles transfer attention from active levels to abstract and subtle levels and reach a state of relaxation, and return to active levels of thinking.
Control group: It do not receive any of the above interventions.
Comparison of the Effectiveness of Interventions Based on the Eastern Mind-Body Approach on Cardiovascular Responses and Stress Reduction in prehypertensive Subjects.
Public title
Comparison of the effectiveness of Eastern mind-body approach on cardiovascular responses and stress in prehypertensive subjects
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Systolic Blood Pressure 120-139mmHg, and/or Diastolic Blood Pressure 80-89mmHg
aged=25-55
Adequate literacy for reading and writing
Ability to attend the sessions
Exclusion criteria:
Sensory-motor disabilities
Use of anxiolytic drugs
Participation in other treatment sessions simultaneously
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No. 66, Mirzaie Alley, Enghelab ave, Maralan street
City
Tabriz
Province
East Azarbaijan
Postal code
5164954933
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
Ethics ID: IR.TBZMED.REC. 1398.539
Health conditions studied
1
Description of health condition studied
prehypertension
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood pressure between 120/80 to 140/90 mm Hg
Timepoint
Blood pressure measurement before the start of the intervention and 10 weeks after the start of the intervention
Method of measurement
digital wrist sphygmomanometer (EmsiG, Model: BW 62)
2
Description
Timepoint
Method of measurement
3
Description
Blood pressure between 120/80 to 140/90 mm Hg
Timepoint
Blood pressure measurement before the start of the intervention and 10 weeks after the start of the intervention
Method of measurement
digital wrist sphygmomanometer (EmsiG, Model: BW 62)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tai chi Chuan
Category
Lifestyle
2
Description
Intervention group: Yoga
Category
Lifestyle
3
Description
Intervention group: Meditation
Category
Lifestyle
4
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz City
Full name of responsible person
Davoud Ezzati
Street address
Maralan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5164954933
Phone
+98 41 3545 3463
Email
ezzatid@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tabriz
Full name of responsible person
Touraj Hashemi Nosrat abad
Street address
Maralan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5164954933
Phone
+98 41 3545 3463
Email
ezzatid@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tabriz
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Davoud Ezzati
Position
ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Maralan street
City
Tabriz
Province
East Azarbaijan
Postal code
5164954933
Phone
+98 41 3545 3463
Email
ezzatid@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Davoud Ezzati
Position
ph.D candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Maralan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5164954933
Phone
+98 41 3545 3463
Email
ezzatid@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Davoud Ezzati
Position
ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Maralan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5164954933
Phone
+98 41 3545 3463
Email
ezzatid@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be presented on average, as our research is a group study.
When the data will become available and for how long
about 2 years
To whom data/document is available
People who work in health areas
Under which criteria data/document could be used
For research, prevention and treatment
From where data/document is obtainable
Davoud Ezzati- University of tabriz- E-mail: ezzatid@yahoo.com
What processes are involved for a request to access data/document
Once the applicant has explained how to use the data in this study along with sufficient documentation, I will deliver the data to him or her within approximately one month.