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The effect of Auricular acupressure on reduction of blood pressure in essential hypertension: A randomized sham-controled clinical trial

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History
# Registration date Revision Id
2 2023-02-13, 1401/11/24 291272
1 2022-08-27, 1401/06/05 237914
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Measurement of systolic and diastolic blood pressure before and after intervention and after 3 months followup
Design
Randomised, sham-controlled , parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out by an external technician
Settings and conduct
The study will be in academic hospitals or private offices.Patient first evaluated by main resarcher(who is a cardiologist)for enterence criteria.Then randomuzation will be by a external technician using computet program.The concealed enveope of the randomization result will be open by main researcher and true or sham intervetion eill be done.Bp will be measured by personel and questionary filled by patients.The patients will be educated regarding trial.
Participants/Inclusion and exclusion criteria
Enternce:1.age>=18. 2..Essential hypertension(not secondary) 3..BP<180\120 in preceding month4..not pregnant or lactating5..no cardiovascular complications 6..no accompaning diseases other than cardiovascular risk factors such as kidney,lung,liver,autoimmune diseases and cancer 7.not taking other drugs such as anticoagulant or seizure drugs8. be able to massage own ear 9 .not participating in another simultaneous trial10.having echocardiography,EKGand routine lab test 11.no history of using auricular acupressure before
Intervention groups
Verum and sham ear acupressure
Main outcome variables
Systolic bllod pressure,diastolic bllod pressure,mean bloid pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110809007265N13
Registration date: 2022-08-27, 1401/06/05
Registration timing: registered_while_recruiting

Last update: 2022-08-27, 1401/06/05
Update count: 1
Registration date
2022-08-27, 1401/06/05
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-21, 1401/05/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Auricular acupressure on reduction of blood pressure in essential hypertension: A randomized sham-controled clinical trial
Public title
Evaluation of ear acupressure on reduction of blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age equal or more than 18 Essential hypertension (not secondary) Having done the general laboratory tests and echocardiography in previous month Doing auricular acupressure for the first time
Exclusion criteria:
Organ disease such as heart, lung ,renal disease … Risk factor for endocarditis such as valvular heart problems
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
This is simple randomization .Each patient takes an concealed envelope containing letter A or B for true or sham group.These envelopes were providid by statistic analyzer of the study. .The operating doctor use insrt either true seed tag or sham seedlee tag to the patients based on letter A or B.These tags are apperantly identical.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients,health personel who check BP and outcomes,resarch analyzer and data gathering person are blinded but the main researcher who intervene with insetion of tags is not blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qorashi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Approval date
2022-07-19, 1401/04/28
Ethics committee reference number
IR.MUMS.REC.1401.122

Health conditions studied

1

Description of health condition studied
Essential hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Systolic blood pressure,Diastolic blood pressure,mean blood pressure
Timepoint
Before and after intervention,at the end of 3 months followup
Method of measurement
Digital arm l sphygmomanometer

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and after the intervention, at the end of 3 month follow up
Method of measurement
Questionary

2

Description
Change in medication dose
Timepoint
Before and after the intervention, at the end of 3 months follow up
Method of measurement
study checklist

Intervention groups

1

Description
Control group: sham(without seed )plaster at acupoints on ear
Category
Treatment - Other

2

Description
Intervention group: Ear acupressure using ear plaster containing seeds
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hoda Azizi
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3802 2035
Email
azizih@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Rahim Firoyzi bostanabad
Position
Ph.D.candidate
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
No.7, Baharan Building, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163951468
Phone
+98 41 3335 9748
Email
rahim4040@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hoda azizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Pardis campus, Azadi squre
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8931
Email
azizih@muma.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoda Azizi
Position
Assiciated Professor of Acupuncture
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Department of Chinese and Complementary Medicine, School of Persian and Complementary Medicine, Azadi Square, Pardis Campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3884 8931
Fax
Email
azizih@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It depends on the written permission of patients who participate in this study
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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