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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Acupressure, Pain, Hemodynamic Instability, Angiopathy, Peripheral

Intervention / Treatment
-----------------
* Other: Acupressure


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, parallel, three-arm randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The experimental group will be given acupressure. | Other: Acupressure<br>* 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.<br>* Other names: Acupress;|
| No Intervention: Control<br>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 |