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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05235841
Other study ID # KahramanmarasSIU2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2018
Est. completion date December 26, 2020

Study information

Verified date February 2022
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 26, 2020
Est. primary completion date October 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
acupressure
Acupressure is a complementary and supportive approach used in symptom management.

Locations

Country Name City State
Turkey Kahramanmaras Sutcu Imam University Kahramanmaras

Sponsors (1)

Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) (T1) 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
Primary Visual Analog Scale (VAS) (T2) 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
Primary Visual Analog Scale (VAS) (T3) 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
Primary Blood Pressure (T1) Digital and Calibrated Blood pressure monitor Baseline
Primary Blood Pressure (T2) The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor 5-15 minutes after coronary angiography
Primary Blood Pressure (T3) The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor 1 hour after the 2nd time blood pressure measurement
Primary Heart Rate (T1) 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
Primary Heart Rate (T2) The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse. 5-15 minutes after coronary angiography
Primary Heart Rate (T3) The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse. 1 hour after the 2nd time heart rate measurement
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