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

October 5, 2021 updated by: Selda Bal, Eastern Mediterranean University

Effect of Acupressure on Pain, Anxiety and Vital Signs in Patients With Coronary Angiography: A Randomized Controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressure Group
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.
Behavioral: Acupressure
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.
Placebo Comparator: Sham Group
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.
Behavioral: Acupressure
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.
No Intervention: Control Group
Patients in the control group will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spielberger State Anxiety Scale
Time Frame: 6 month
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.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Pain Scale
Time Frame: 6 month
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Mediterranean University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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