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Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography

Primary Purpose

Pain, Anxiety, Vital Signs

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Acupressure
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring pain, anxiety, vital signs, coronary angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • First time coronary angiography performed
  • Coronary angiography performed from the femoral region,
  • over the age of 18,
  • Willing to participate in the research,
  • Able to understand and speak Turkish,
  • Open to communication,
  • Planned (non-urgent) coronary angiography
  • No complications after angiography
  • Stent etc. during angiography. no other attempt has been made
  • No deformity or lesion in the areas where acupressure will be applied
  • Not taking sedatives or pain relievers 5 hours before the angiography procedure,
  • No acupressure experience
  • Not diagnosed with anxiety disorder and not receiving medical treatment
  • Not diagnosed with depression and not receiving medical treatment
  • No chronic pain
  • Patients without mental illness.

Exclusion Criteria:

  • - Previous coronary angiography
  • Coronary angiography from the femoral region is not performed,
  • under the age of 18,
  • pregnant,
  • Those who do not agree to participate in the research,
  • Can't understand or speak Turkish,
  • Unable to communicate
  • Unplanned (urgent) Coronary angiography Patients
  • Any complications after angiography
  • Stent etc. during angiography. another attempt has been made
  • Any deformity or lesion in the areas where acupressure will be applied,
  • Those who took sedatives or painkillers 5 hours before the angiography procedure,
  • Experience with acupressure
  • Anxiety disorder and receiving treatment,
  • Diagnosed with depression and receiving treatment,
  • Having chronic pain,
  • Patients with mental disorders.

Sites / Locations

  • Selda Bal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Acupressure Group

Sham Group

Control Group

Arm Description

Applicable to the acupressure group; Heart meridian 7th point (HT7), large intestine meridian 4th point (LI4) and pericardium 6th point (PC6), a total of three points will be applied. Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher without lifting the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief. Since the symmetry of the selected three different points on the other extremity will also be applied, a total of 12 minutes of compression will be applied to each point, provided that it is two minutes. Depending on the preparation and compression time on each point, the session duration of each patient will be approximately 16 minutes.

n the acupressure application to the Sham group, pressure will be exerted on the bone region where the meridians do not pass, parallel to the HT7, LI4, PC6 and points (approximately 1-1.5 cm away) (Figure 4). Before the application, the acupressure points will be heated for about 20 seconds and the tissue sensitivity will be reduced by rubbing and they will be made ready for the acupressure application. Afterwards, the acupressure points determined will be pressed with the thumb by the researcher with a lower intensity than the normal application pressure for two minutes. Similar to the acupressure group, the sham group will be applied to symmetrical points. In this direction, a session will last 16 minutes for each patient, as in the acupressure group, together with the duration of the pre-procedure preparation and applications.

Patients in the control group will not receive any intervention.

Outcomes

Primary Outcome Measures

Spielberger State Anxiety Scale
The scale consists of 20 statements. The total score can range from 20 to 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

Secondary Outcome Measures

Visual Pain Scale
It is a scale that is evaluated by individuals by making markings on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the patient is very good and the other end is very bad.

Full Information

First Posted
September 8, 2021
Last Updated
October 5, 2021
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT05082506
Brief Title
Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography
Official Title
Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

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

5. Study Description

Brief Summary
The study was planned to determine the effect of acupressure on pain, anxiety and vital signs of patients with coronary angiography. Acupressure application was carried out by the responsible researcher, who is certified on this subject, by TRNC Dr. In the Cardiology Service of Burhan Nalbantoğlu Hospital, patients who have undergone angiography will be applied and measurements will be made before mobilization after their informed consent is obtained.
Detailed Description
In this study, it is aimed to raise awareness for the use of painless, painless, economical, side-effect-free and easy-to-apply acupressure in nursing care in order to increase patient comfort by relieving pain and anxiety of patients during mandatory bed rest after coronary angiography. In addition, our study is important in terms of providing new information with a high level of evidence and providing a source for other studies on this subject. Objective: The study was planned to determine the effect of acupressure on pain, anxiety and vital signs of patients with coronary angiography. Hypothesis 1 H0: There is no difference in Visual Analog Scale mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group. H1: There is a difference in Visual Analog Scale mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group. Hypothesis 2 H0: There is no difference between the Spielberger State Anxiety Inventory mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group. H1: There is a difference between the Spielberger State Anxiety Inventory mean scores between the acupressure group, the sham (pseudo-acupressure) group, and the control group. Hypothesis 3 H0: There is no difference in Systolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group. H1: There is a difference in Systolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group. Hypothesis 4 H0: There is no difference in Diastolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group. H1: There is a difference in Diastolic Blood Pressure between the acupressure group, the sham (false acupressure) group and the control group. Hypothesis 5 H0: There is no difference in Heart Rate between the acupressure group, the sham (false acupressure) group and the control group. H1: There is a difference between the acupressure group, the sham (false acupressure) group and the control group in terms of Heart Rate. Hypothesis 6 H0: There is no difference in Respiration Rate between the acupressure group, the sham (false acupressure) group and the control group. H1: There is a difference between the acupressure group, the sham (false acupressure) group and the control group in terms of Respiration Rate. Hypothesis 7 H0: There is no difference in Cortisol Level between the acupressure group, the sham (false acupressure) group and the control group. H1: There is a difference between the acupressure group, the sham (false acupressure) group and the control group in terms of Cortisol Level. "Personal Information Form, "Spielberger State Anxiety Scale", "Visual Analogue Scale" and "Vital Signs Follow-up Form" will be administered to all patients (acupressure, sham acupressure and control groups) included in the study (1. "Spielberger State Anxiety Inventory", "After the measurement, half an hour after applying acupressure to the points determined for both groups (2nd measurement), two hours later (3rd measurement) and just before mobilization (4th measurement)," "Visual Analogue Scale" and "Vital Signs Follow-up Form" will be applied again. It was created by the researcher to track the cortisol level. It is designed to include a total of 2 measurements (pre/post acupressure).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Vital Signs, Coronary Angiography
Keywords
pain, anxiety, vital signs, coronary angiography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Since the patients who will be included in the study are not known in advance, the patients will be randomized by the statistician using GraphPad software 3 and the block randomization technique, in order to assign the same number of participants to each group before the study, and will be divided into groups A, B, and C.
Masking
Participant
Masking Description
As a result of the draw, group A was determined as acupressure, group B as sham acupressure and group C as the control group. Since pressure will be applied to the pressure points of the patients in the acupressure and sham group included in the study, the sham (placebo) acupressure and acupressure groups will be blinded, since the patients do not know whether acupressure or sham acupressure is applied. The control group and the researcher cannot be blinded due to the nature of the research.
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressure Group
Arm Type
Experimental
Arm Description
Applicable to the acupressure group; Heart meridian 7th point (HT7), large intestine meridian 4th point (LI4) and pericardium 6th point (PC6), a total of three points will be applied. Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher without lifting the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief. Since the symmetry of the selected three different points on the other extremity will also be applied, a total of 12 minutes of compression will be applied to each point, provided that it is two minutes. Depending on the preparation and compression time on each point, the session duration of each patient will be approximately 16 minutes.
Arm Title
Sham Group
Arm Type
Placebo Comparator
Arm Description
n the acupressure application to the Sham group, pressure will be exerted on the bone region where the meridians do not pass, parallel to the HT7, LI4, PC6 and points (approximately 1-1.5 cm away) (Figure 4). Before the application, the acupressure points will be heated for about 20 seconds and the tissue sensitivity will be reduced by rubbing and they will be made ready for the acupressure application. Afterwards, the acupressure points determined will be pressed with the thumb by the researcher with a lower intensity than the normal application pressure for two minutes. Similar to the acupressure group, the sham group will be applied to symmetrical points. In this direction, a session will last 16 minutes for each patient, as in the acupressure group, together with the duration of the pre-procedure preparation and applications.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in the control group will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Acupressure
Intervention Description
Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher without lifting the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief.
Primary Outcome Measure Information:
Title
Spielberger State Anxiety Scale
Description
The scale consists of 20 statements. The total score can range from 20 to 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Visual Pain Scale
Description
It is a scale that is evaluated by individuals by making markings on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the patient is very good and the other end is very bad.
Time Frame
6 month

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: First time coronary angiography performed Coronary angiography performed from the femoral region, over the age of 18, Willing to participate in the research, Able to understand and speak Turkish, Open to communication, Planned (non-urgent) coronary angiography No complications after angiography Stent etc. during angiography. no other attempt has been made No deformity or lesion in the areas where acupressure will be applied Not taking sedatives or pain relievers 5 hours before the angiography procedure, No acupressure experience Not diagnosed with anxiety disorder and not receiving medical treatment Not diagnosed with depression and not receiving medical treatment No chronic pain Patients without mental illness. Exclusion Criteria: - Previous coronary angiography Coronary angiography from the femoral region is not performed, under the age of 18, pregnant, Those who do not agree to participate in the research, Can't understand or speak Turkish, Unable to communicate Unplanned (urgent) Coronary angiography Patients Any complications after angiography Stent etc. during angiography. another attempt has been made Any deformity or lesion in the areas where acupressure will be applied, Those who took sedatives or painkillers 5 hours before the angiography procedure, Experience with acupressure Anxiety disorder and receiving treatment, Diagnosed with depression and receiving treatment, Having chronic pain, Patients with mental disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SELDA BAL, 1
Phone
+905338717636
Email
selda.bal@emu.edu.tr
Facility Information:
Facility Name
Selda Bal
City
Famagusta
ZIP/Postal Code
99450
Country
Cyprus
Facility Contact:
First Name & Middle Initial & Last Name & Degree
selda bal, 1
Phone
05338717636
Email
selda.bal@emu.edu.tr
First Name & Middle Initial & Last Name & Degree
meral gün, 2
Phone
05337301788
Email
meralgun@mersin.edu.tr
First Name & Middle Initial & Last Name & Degree
selda bal, 1

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
33501848
Citation
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Results Reference
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Results Reference
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Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography

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