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Clinical Trials/NCT05082506
NCT05082506UnknownNot 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 enrollmentStarted: December 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
105
Locations
1
Primary Endpoint
Spielberger State Anxiety Scale

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Acupressure Group

Experimental

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.

Intervention: Acupressure (Behavioral)

Sham Group

Placebo Comparator

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.

Intervention: Acupressure (Behavioral)

Control Group

No Intervention

Patients in the control group will not receive any intervention.

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Selda Bal

SENİOR İNSTRUCTİON

Eastern Mediterranean University

Study Sites (1)

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