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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04769219
Other study ID # AIBU-KYB-AYN-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date August 31, 2021

Study information

Verified date December 2023
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of secondary prevention education given to individuals after acute myocardial infarction on physiological parameters, anxiety and quality of life.


Description:

The aim of this study is to examine the effect of secondary prevention education given to individuals after acute myocardial infarction on physiological parameters, anxiety and quality of life.The population of the study will be the individuals hospitalized with the diagnosis of acute myocardial infarction in the Coronary Intensive Care Unit of Abant Izzet Baysal University Izzet Baysal Training and Research Hospital. The study will be conducted in a randomized controlled manner with two groups, 43 in the control group and 43 in the secondary prevention education group. CAG (Coronary Angiography) Procedure Training Form, Patient Identification Form, Physiological Parameters Form and Visual Analogue Scale, Spielberg State and Trait Anxiety Scale and Myocardial Infarction Dimensional Assessment Scale will be used to collect data. The data will be collected by face to face interview technique. For descriptive statistics, mean and standard deviation or median and minimum-maximum values for numerical variables, number and percentage values for categorical variables will be given. The Kolmogorov-Smirnov test (p <0.05), skewness and kurtosis coefficients (should be ± 1) and X ̅ / SS <4 inequalities will be examined at the same time, and the weight in which group will be preferred.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date August 31, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - First time AMI and inpatient treatment in the coronary intensive care unit, - Not having received training after AMI * - Being 18 years or older, - Speak Turkish, - No problem in verbal communication, - Absence of hearing loss, - Not being diagnosed with a psychiatric illness, - Being conscious, - Being volunteer to participate in the study, - Routine check of cholesterol, HDL, LDL, triglyceride results at the beginning of the study and at 6 months. Exclusion Criteria: Not having had AMI for the first time - Having received training after AMI - Not willing to participate in the study, - Cannot speak Turkish, - Problems in verbal communication, - Having hearing loss, - Having a diagnosis of psychiatric illness, - Unconsciousness. - Cholesterol, HDL, LDL, triglyceride results were not routinely checked at the start and 6 months of the study.

Study Design


Intervention

Other:
Secondary prevention training
Secondary prevention training will be given after acute myocardial infarction

Locations

Country Name City State
Turkey Abant Izzet Baysal University Merkez Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other means of blood pressure (mmHg) In the study, a digital sphygmomanometer, which has been calibrated in comparison with the mercury sphygmomanometer, is used in order to prevent individual differences in the measurement of blood pressure. For accurate results, the sphygmomanometer sleeve is sized for adult individuals (width = about 20 cm, length = about 40 cm). In order for the blood pressure not to be affected by the conditions during the measurement, it is taken into account that the individual did not drink tea or coffee, take caffeine, and preferably did not eat during the 30 minutes prior to measurement. six months
Other means of total cholesterol (mg/dl) The values measured during routine blood checks will be taken for cholesterol values in this study. six months
Other means of HDL cholesterol (mg/dl) The values measured during routine blood checks will be taken for cholesterol values in this study. six months
Other means of LDL cholesterol (mg/dl) The values measured during routine blood checks will be taken for cholesterol values in this study. six months
Other means of triglyceride (mg/dl) The values measured during routine blood checks will be taken for cholesterol values in this study. six months
Primary means of subjective anxiety scores Spielberg State- Trait Anxiety Scale. The total score between 0-19 obtained from the state anxiety scale shows that there is no anxiety, the total score between 20-39 indicates mild, the average score between 40-59 indicates moderate, and the total score between 60-79 indicates severe anxiety, and over 60 points are needed for professional help. The scores obtained from the trait anxiety scale vary between 20 and 80. A high score means a high and a low level means anxiety six months
Primary means of subjective quality of life scores It consists of 35 items and the quality of life is based on physical activity (12 items), insecurity (9 items), emotional response (4 items), addiction (3 items), diet (3 items), concerns about medication (2 items), Each sub-dimension of MIDAS, which measures seven domains as (2 items), is scored between 0-100. High scores indicate poor health. six months
Secondary means of subjective pain score visual analog scale. It consists of a straight line with endpoints that define end limits such as "no pain" and "pain as bad as possible". The patient is asked to mark the level of pain on the line between the two endpoints. six months
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