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Effect of Acupressure on Blood Pressure, Heart Rate and Pain Severity

Primary Purpose

Acute Pain, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
acupressure
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Pain focused on measuring Acupressure, Coronary Angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kahramanmaras Sutcu Imam University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AG

CG

Arm Description

The group that met the criteria of the study and applied acupressure protocol before Coronary Angiography

BEFORE CORONARY ANGIOGRAPHY, THE GROUP WITHOUT ANY INTERVENTION, CONTROL GROUP

Outcomes

Primary Outcome Measures

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.
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.
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.
Blood Pressure (T1)
Digital and Calibrated Blood pressure monitor
Blood Pressure (T2)
The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
Blood Pressure (T3)
The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2021
Last Updated
February 1, 2022
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT05235841
Brief Title
Effect of Acupressure on Blood Pressure, Heart Rate and Pain Severity
Official Title
Effect of Acupressure on Blood Pressure, Heart Rate and Pain Severity of Patients Underwent Coronary Angiography: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
December 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Blood Pressure
Keywords
Acupressure, Coronary Angiography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized two arm (intervention and usual care) clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AG
Arm Type
Experimental
Arm Description
The group that met the criteria of the study and applied acupressure protocol before Coronary Angiography
Arm Title
CG
Arm Type
No Intervention
Arm Description
BEFORE CORONARY ANGIOGRAPHY, THE GROUP WITHOUT ANY INTERVENTION, CONTROL GROUP
Intervention Type
Other
Intervention Name(s)
acupressure
Intervention Description
Acupressure is a complementary and supportive approach used in symptom management.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) (T1)
Description
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.
Time Frame
Baseline
Title
Visual Analog Scale (VAS) (T2)
Description
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.
Time Frame
5-15 minutes after coronary angiography
Title
Visual Analog Scale (VAS) (T3)
Description
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.
Time Frame
1 hour after the 2nd time VAS assessment
Title
Blood Pressure (T1)
Description
Digital and Calibrated Blood pressure monitor
Time Frame
Baseline
Title
Blood Pressure (T2)
Description
The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
Time Frame
5-15 minutes after coronary angiography
Title
Blood Pressure (T3)
Description
The pressure exerted by the circulating blood on the vessel wall is called blood pressure.Digital and Calibrated Blood pressure monitor
Time Frame
1 hour after the 2nd time blood pressure measurement
Title
Heart Rate (T1)
Description
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
Time Frame
Baseline
Title
Heart Rate (T2)
Description
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
Time Frame
5-15 minutes after coronary angiography
Title
Heart Rate (T3)
Description
The pressure exerted by the circulating blood on the vessel wall is called blood.A calibrated pulse-oximeter was used to measure the pulse.
Time Frame
1 hour after the 2nd time heart rate measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
emine derya ister, pHD
Organizational Affiliation
Kahramanmaraş Sütçü İmam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University
City
Kahramanmaraş
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36112790
Citation
Derya Ister E, Altinbas Y. Effect of Acupressure on the Blood Pressure, Heart Rate, and Pain Severity of Patients who Underwent Coronary Angiography: A Randomized Controlled Trial. Altern Ther Health Med. 2023 Oct;29(7):216-221.
Results Reference
derived

Learn more about this trial

Effect of Acupressure on Blood Pressure, Heart Rate and Pain Severity

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