- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05235841
Effect of Acupressure on Blood Pressure, Heart Rate and Pain Severity
Effect of Acupressure on Blood Pressure, Heart Rate and Pain Severity of Patients Underwent Coronary Angiography: A Randomized Controlled Trial
Objective: The aim of this study was to evaluate the effect of acupressure applied before CA procedure on systolic and diastolic blood pressure, mean arterial pressure, pulse and pain intensity parameters after CA.
Design: The study is a randomized controlled trial. Setting: The study occurred at Cardiology Service (CS) of a Training and Research Hospital in Turkey.
Participants: One hundred patients whomet the research criteria.
Study Overview
Detailed Description
Heart disease is the most important cause of mortality and morbidity in developed and developing countries, despite all preventive and therapeutic initiatives and newly developed methods.Besides the drug treatments, interventional procedures are also used to diagnose and treat some heart diseases, which are life-saving and have few risks. CA, one of the interventional methods commonly used for this purpose, is the process of obtaining cine-angiographic images by injecting contrast agents into femoral, brachial, radial, axillary arteries.
People experience fear of death and consequent anxiety because CA is an invasive diagnostic method. There is a lot of uncertainty about the procedure, and the usage of this method in the diagnosis of an organ with high vital importance, such as the heart, causes fear.High levels of stress cause cardiac irritability and increased blood pressure; while anxiety and stress persist, temporary myocardial ischemia, increased heart rate, palpitations, and chest pain may develop.
The aim of nursing care in CA patients is to ensure the relief and comfort of the patient before, during, and after the procedure, to determine and prevent complications that may develop at an early stage.It is noted that reducing anxiety and pain before and after CA is essential in ensuring the stability of vital signs. Acupressure used for this purpose is a non-pharmacological nursing initiative that can relieve and reduce pain and regulate anxiety-related blood pressure. This study evaluates the impact of acupressure applied before CA on systolic and diastolic blood pressure, mean arterial pressure, pulse, and pain severity parameters after CA.
Design: The study was a randomized controlled trial. Setting: The study occurred at Cardiology Service (CS) of a Training and Research Hospital in Turkey.
Participants: One hundred patients, met the research criteria were divided into 50 in the intervention (IG) and 50 in the control group (CG) by simple randomization method.
Intervention: The IG received acupressure and the CG received no acupressure. Acupressure was applied to patients in the IG 30-60 minutes before CA. In the study the Li4, HT7, and Extra 1 acupressure points and repeated measures were selected; pain intensity, systolic and diastolic blood pressure and pulse parameters of the patients were measured three times.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kahramanmaraş, Turkey
- Kahramanmaras Sutcu Imam University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being 18 years of age and older
- undergoing the coronary angiography process for the first time
- planned coronary angiography
- be able to communicate
Exclusion Criteria:
- having psychological or mental disorders
- having a limb amputation
- receiveing therapy such as massage or acupressure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AG
The group that met the criteria of the study and applied acupressure protocol before Coronary Angiography
|
Acupressure is a complementary and supportive approach used in symptom management.
|
No Intervention: CG
BEFORE CORONARY ANGIOGRAPHY, THE GROUP WITHOUT ANY INTERVENTION, CONTROL GROUP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) (T1)
Time Frame: Baseline
|
The patient marks his or her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other.
|
Baseline
|
Visual Analog Scale (VAS) (T2)
Time Frame: 5-15 minutes after coronary angiography
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The patient marks his or her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other.
|
5-15 minutes after coronary angiography
|
Visual Analog Scale (VAS) (T3)
Time Frame: 1 hour after the 2nd time VAS assessment
|
The patient marks his or her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other.
|
1 hour after the 2nd time VAS assessment
|
Blood Pressure (T1)
Time Frame: Baseline
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Digital and Calibrated Blood pressure monitor
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Baseline
|
Blood Pressure (T2)
Time Frame: 5-15 minutes after coronary angiography
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The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
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5-15 minutes after coronary angiography
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Blood Pressure (T3)
Time Frame: 1 hour after the 2nd time blood pressure measurement
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The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
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1 hour after the 2nd time blood pressure measurement
|
Heart Rate (T1)
Time Frame: Baseline
|
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
|
Baseline
|
Heart Rate (T2)
Time Frame: 5-15 minutes after coronary angiography
|
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
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5-15 minutes after coronary angiography
|
Heart Rate (T3)
Time Frame: 1 hour after the 2nd time heart rate measurement
|
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
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1 hour after the 2nd time heart rate measurement
|
Collaborators and Investigators
Investigators
- Principal Investigator: emine derya ister, pHD, Kahramanmaras Sutcu Imam University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KahramanmarasSIU2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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