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Clinical Trials/NCT05082506
NCT05082506
Unknown
Not Applicable

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

Eastern Mediterranean University1 site in 1 country105 target enrollmentDecember 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Eastern Mediterranean University
Enrollment
105
Locations
1
Primary Endpoint
Spielberger State Anxiety Scale
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 15, 2021
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Selda Bal

SENİOR İNSTRUCTİON

Eastern Mediterranean University

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

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Visual Pain Scale(6 month)

Study Sites (1)

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