Protocol summary
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Study aim
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Measurement of changes in systolic and diastolic blood pressure before and after intervention and after 1months followup after ear acupuncture intervention
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Design
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Randomized, sham-controlled , parallel group trial with blinded outcome assessment. Randomization was centralized and computerized with concealed randomization sequence carried out by an external technician.sample volume was60 and each group had 30 patients.
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Settings and conduct
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.Before conducting the study, the purpose and procedure of the study were explained
to the subjects and a written consent for the study participation was obtained.شار زیر180/120ئ
The subjects of this study were recruited from Mashhad university of medical science health centers in Mashhad, Iran. The inclusion criteria were adult people over 18 years old with
essential hypertension,who had not have blood pressure more than 180/120mmhg in preceding month , and not taking acupuncture or participating in another study. The exclusion criteria were those who had cardiovascular complication such as heart failure or stoke,other significant diseases such as liver or renal disease,taking drugs for seizure or cancer,women who were pregnant or breastfeeding,
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Participants/Inclusion and exclusion criteria
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Inclusion criteria :1.age>=18. 2.Essential hypertension(not secondary) 3..BP<180\120 in preceding month
Exclusion criteria:1. cardiovascular complications 2.accompanying diseases such as kidney,lung,liver,autoimmune diseases and cancer 3. taking other drugs such as anticoagulant or seizure drugs.
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Intervention groups
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intervention group are patients with essential hypertension who receive. needle- containing adhesive tapes .
placebo group are patients with essential hypertension who receive. needle- free adhesive tapes .
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Main outcome variables
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Systolic blood pressure,diastolic blood pressure,mean blood pressure
General information
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Reason for update
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change in method which includes substitution of needle containing tages ,so no need to pressure on tages because needle stimulates the points and in this method patients will be completely blinded.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110809007265N13
Registration date:
2022-08-27, 1401/06/05
Registration timing:
registered_while_recruiting
Last update:
2024-01-09, 1402/10/19
Update count:
1
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Registration date
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2022-08-27, 1401/06/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-21, 1401/05/30
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Expected recruitment end date
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2022-09-21, 1401/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Auricular acupuncture on reduction of blood pressure in patients with chronic essential hypertension: A randomized sham-controled clinical trial
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Public title
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Evaluation of ear acupuncture on reduction of blood pressure
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age equal or more than 18
Essential hypertension (not secondary)
blood pressure less than 180/120 mmHg in preceding month
Exclusion criteria:
Organ disease such as heart, lung ,renal disease …
cardiovascular complications
taking drug for cancer .seizure
participation in other trials
taking acupuncture
pregnant or breast-feeding
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This is simple randomization .Each patient takes an concealed envelope containing letter A or B for true or sham group.These envelopes were provided by statistic analyzer of the study.
The main researcher pastes either true needle tag or sham needle-free tag to the patients based on letter A or B.These tags are apparently identical.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The patients,health personnel who check BP and outcomes,research analyzer and data gathering person are blinded but the main researcher who inserts adhesive tapes is not blinded.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-07-19, 1401/04/28
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Ethics committee reference number
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IR.MUMS.REC.1401.122
Health conditions studied
1
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Description of health condition studied
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Essential hypertension
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ICD-10 code
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I10
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ICD-10 code description
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Essential (primary) hypertension
Primary outcomes
1
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Description
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Systolic blood pressure,Diastolic blood pressure,mean blood pressure
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Timepoint
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Before and after intervention,at the end of 1 month followup
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Method of measurement
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Digital arm sphygmomanometer
Secondary outcomes
1
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Description
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Quality of life
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Timepoint
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Before and after the intervention, at the end of 1 month follow up
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Method of measurement
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Questionary
2
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Description
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Change in medication dose
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Timepoint
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Before and after the intervention, at the end of 1 months follow up
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Method of measurement
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study checklist
Intervention groups
1
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Description
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After randomization,standard SF-36questionarie filled out by patients and blood pressure measured by digital arm sphygmomannometer.4 adhesive tape containg1mm needle in its center are pasted to specific ear points(shenmen,superior triangular fossa,Chinese liver and heart )on right ear.7 days later patients will come back and tapes removed and blood pressure be measured and new tapes pasted on the points on left ear.4 times (4weeks) will be dine again with tapes 2weeks on right and 2weeks on left ear.at end of last session SF-36questionarie will be filled by patients.after one month patients will come back for follow up and blood pressure will be measured and the questionnaire will be filled.
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Category
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Treatment - Other
2
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Description
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After randomization,standard SF-36 questionarie filled out by patients and blood pressure measured by digital arm sphygmomannometer.4 adhesive tape free of needle are pasted to specific ear points(shenmen,superior triangular fossa,Chinese liver and heart ) on right ear. Seven days later patients will come back and tapes removed and blood pressure be measured and new tapes pasted on the points on left ear.Four times (4 weeks) will be done again with tapes 2 weeks on right and 2 weeks on left ear.at end of last session SF-36 questionarie will be filled by patients. After one month patients will come back for follow up and blood pressure will be measured and the questionnaire will be filled.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It depends on the written permission of patients who participate in this study
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available