Effect of Acupressure Applied Before CAG on Pain, Anxiety and Vital Signs

NCT06916351 | Completed

• 2 other identifiers: BandirmaOnyediEylul UniversityEthics Committee
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled experimental study aimed to determine the effects of acupressure applied before the procedure on pain, anxiety and vital signs in patients who applied to Kocaeli City Hospital Angiography Unit and were to undergo planned radial artery coronary angiography.

Conditions

Acupressure; Coronary Angiography and Intervention

Keywords

pain; coronary angiography; anxiety; vital signs; Acupressure; nursing care

Outcome Measures

Primary Outcomes (2)

• State-Trait Anxiety Scale (STAI)

  The State-Trait Anxiety Scale (STAI) is a scale developed by Spielberger et al. in 1970. The STAI determines how an individual feels at a certain moment and under a certain condition. The Turkish adaptation of the STAI was made by Öner and Le Compte in 1983 and the Cronbach alpha coefficient was reported as 0.94 (Öner and Le Compte, 1985). The STAI consists of 20 questions on a four-point Likert type. The statements in the STAI are evaluated as not at all 1 point, a little 2 points, a lot 3 points and completely 4 points. In this section, the statements are divided into direct and reversed. The scale score varies between 20-80 and an increase in the score obtained from the scale indicates an increase in the anxiety level. A score of 0-19 indicates no anxiety, a score of 20-39 indicates mild, a score of 40-59 indicates moderate and a score of 60-79 indicates severe anxiety. It is stated that those who score 60 points and above need professional help.

  Before acupressure application, 20 minutes after acupressure application (20 minutes after application in the sham acupressure group, 20 min. after the initial measurement in the control group), immediately after the CABG procedure, 2 and 4 hours later

• Visual pain scale for pain assessment

  The scale is a 10 cm vertical or horizontal line on which patients mark their pain, with no pain written on one end and unbearable pain on the other. The distance between where the patient marks their pain and the no pain range is measured and recorded. The scale consists of five parts. Each of the sections is in the range of 2 points. '0' points - no pain, '1-2 points, very mild pain', '3-4 points, mild pain', '5-6 points, moderate pain', '7-8 points, severe pain' means '9-10 points, excruciating pain'.

  Before acupressure application, 20 minutes after acupressure application (20 minutes after application in the sham acupressure group, 20 min. after the initial measurement in the control group), immediately after the CABG procedure, 2 and 4 hours later

Secondary Outcomes (4)

• The blood pressure measurements

  Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.

• The heart rate measurement

  Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.

• Respiratory rate

  Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.

• Oxygen saturation

  Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.

Study Arms (3)

Sham acupressure

PLACEBO COMPARATOR

Sham acupressure will be applied to three points parallel to HT7, LI4 and PC6, approximately 1-1.5 cm away from the meridians. To prepare the points for acupressure, these points will be rubbed for approximately 20-30 seconds without applying direct pressure, reducing tissue sensitivity. The researcher will then apply acupressure to these points and symmetrical points using the thumb for three minutes, but will apply less pressure than required levels. Similar to the acupressure group, preparations and acupressure application will take approximately 20 minutes in total for each patient.

Other: Sham acupressure

Control

NO INTERVENTION

Patients in the control group will not receive any intervention and will receive routine treatment and care.

Acupressure

EXPERIMENTAL

Acupressure will be applied to a total of three points, namely HT7, LI4, and PC6, determined by the researcher with a certificate according to literature and expert opinion before the CAG procedure for the acupressure group. The "cun" measurement unit will be used to determine the points where the application will be made. Before the application, after approximately 20-30 seconds of heating and rubbing without direct pressure on the acupressure points, the researcher will manually press the determined acupressure points with the thumb for 10 seconds to create a depth of 1-1.5 cm. Pressure will be applied to each acupressure point for three consecutive minutes (in the breathing rhythm) without lifting the finger, allowing for two seconds of relaxation. Since the symmetry of the three different points selected on the other extremity will also be applied, a total of 18 minutes of pressure will be applied to each point, with the condition of three minutes.

Other: Acupressure

Interventions

Acupressure OTHER

Acupressure will be applied to a total of three points: the 4th point of the Large Intestine Meridian (LI4-Hegu point) and the 6th point of the pericardial meridian (PC6- Nei Guan point), located three fingers above the wrist.

Acupressure

Sham acupressure OTHER

Sham acupressure will be applied to three points parallel to HT7, LI4 and PC6, approximately 1-1.5 cm away from the meridians.

Sham acupressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age,
• Able to understand and speak Turkish,
• Open to communication,
• First time undergoing radial artery coronary angiography,
• Elective patients undergoing planned (non-urgent) coronary angiography,
• Patients who did not undergo stent/balloon intervention during angiography,
• Awake and conscious during coronary intervention (not having taken sedatives (dormicum/fentanyl))
• No deformities or lesions in the areas where acupressure will be applied (hematoma, ecchymosis, etc.)
• Having not taken sedatives or painkillers 5 hours before the angiography,
• No experience with acupressure,
• No history of attending training courses and yoga classes to control stress and anxiety in the last six months
• No diagnosis of anxiety disorder and not receiving medical treatment
• No diagnosis of depression and not receiving medical treatment
• Flat on the back (patients without respiratory distress, etc.),
• Hemodynamically stable (no chest pain or arrhythmia),

You may not qualify if:

• Diagnosed with any psychiatric disease
• Previously undergone coronary angiography from the radial or femoral artery
• Chronic pain
• Used opioid medication
• CAG procedure to be performed from the femoral artery

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, İzmit, 41001, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant does not know which group he/she is in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse, graduate student

Model Details: It is a single-blind, parallel group, pre-test-post-follow-up randomized controlled experimental study.

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 8, 2025
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)