The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables (Acupress)

The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables Randomized Controlled Study

This randomized controlled study evaluates the effect of acupressure application on the pain level patients after angioography. The hypothesis of this study is that acupressure reduces pain levels and stabilizes hemodynamic variables.

Study Overview

• Status: Completed
• Conditions: Pain; Hemodynamic Instability; Acupressure; Angiopathy, Peripheral
• Intervention / Treatment: Other: Acupressure

Detailed Description

In the study, 124 patients will randomly assigned to acupressure/experimental group and control group. To the acupressure/experimental group (n = 62), an average of 15 minutes will be applied to the LI4 (liver, between thumb and forefinger), P6 (pericardium, three fingers above the wrist) and LI 11 is located the area where the elbow bend. On the other hand, no other intervention will be applied to the control group other than routine treatment and nursing care. The primary outcome of the research is the effect of acupressure on the pain of patients. The secondary outcome of the study is to determine the effect of acupressure on the hemodynamic variables. The pain and hemodynamic variables will be collected before, immediately after the application, 10th, 20th and 30th minutes after the application. Data will also be collected from the control group at the same time.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Turkey/Mersin,Yenişehir
    • Mersin, Turkey/Mersin,Yenişehir, Turkey, 33343
      • Turkey, Mersin University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Agreeing to participate in the research (signing the Informed Consent Form),
• Conscious and cooperative,
• Speaks and understands Turkish,
• Over 18 years of age,
• Stable general condition,
• No sensitivity in the area where acupressure will be applied,
• No active COVID-19 infection,
• Patients without any psychiatric diagnosis will be included.

Exclusion Criteria:

• Do not agreeing to participate in the research (signing the Informed Consent Form),
• Do not conscious and cooperative,
• Do not speaks and understands Turkish,
• Do not over 18 years of age,
• Do not stable general condition,
• Having sensitivity in the area where acupressure will be applied,
• Having active COVID-19 infection,
• Patients with any psychiatric diagnosis will be included.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The experimental group will be given acupressure.	Other: Acupressure; The experimental group will start with LI4 points and continue P6 and LI11 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.; Other Names: Acupress
No Intervention: Control; It will only take routine treatment and care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluated using the visual analog scale	The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.	Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Systolic blood pressure (SBP), mmHg	Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Diastolic blood pressure	Diastolic blood pressure (DBP), mmHg	Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Heart rate	Beats per minute	Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Respiratory rate	Lung breathing	Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Peripheral oxygen saturation	%, percentage of oxygenated hemoglobin in peripheral arterial blood	Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

Collaborators and Investigators

• Sponsor: Mersin University
• Investigators: Study Director: Gülay Altun Ugras, PhD, Mersin University; Principal Investigator: Canan KANAT, Master, Mersin University; Principal Investigator: Barış DÜZEL, Specialist, Mersin City Research and Application Hospital

Publications and helpful links

General Publications

• Rajaee, N., Choopani, N., Pishgoei, A. H., & Sharififar, S. (2015). The effect of acupressure on Patient's anxiety who candidate for coronary angiography. Military Caring Sciences, 1 (3), 6-13.
• The effect of acupressure on vital signs, acute pain, stress and satisfaction during venipuncture: Single-blind, randomized controlled study. European

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: MersinUnive

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No