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Secondary Prevention Education After Acute Myocardial Infarction

Primary Purpose

Myocardial Infarction, Acute, Anxiety, Education

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Secondary prevention training
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Infarction, Acute focused on measuring myocardial infarction, anxiety, education, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Abant İzzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

secondary prevention training

nursing care

Arm Description

Secondary prevention training will be given to 43 randomly selected patients between the fourth and sixth hours after AMI (in accordance with the patient's request). Secondary protection training will be carried out in two parts. First of all, the anatomical structure and functions of the heart, the definition of AMI, its causes, symptoms and risk factors will be explained, and then the issues to be considered after AMI will be explained. The content of the training will also be given to the participants in a written booklet.

43 randomly selected patients will form the control group and this group will be provided with routine care and follow-up in the clinic. No intervention will be made.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 21, 2021
Last Updated
April 6, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04769219
Brief Title
Secondary Prevention Education After Acute Myocardial Infarction
Official Title
The Effect of Secondary Prevention Education Given to Individuals After Acute Myocardial Infarction on Physiological Parameters, Anxiety and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute, Anxiety, Education, Quality of Life
Keywords
myocardial infarction, anxiety, education, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are 2 groups as intervention and control
Masking
Participant
Masking Description
the participant did not know which group he was in.
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
secondary prevention training
Arm Type
Experimental
Arm Description
Secondary prevention training will be given to 43 randomly selected patients between the fourth and sixth hours after AMI (in accordance with the patient's request). Secondary protection training will be carried out in two parts. First of all, the anatomical structure and functions of the heart, the definition of AMI, its causes, symptoms and risk factors will be explained, and then the issues to be considered after AMI will be explained. The content of the training will also be given to the participants in a written booklet.
Arm Title
nursing care
Arm Type
No Intervention
Arm Description
43 randomly selected patients will form the control group and this group will be provided with routine care and follow-up in the clinic. No intervention will be made.
Intervention Type
Other
Intervention Name(s)
Secondary prevention training
Intervention Description
Secondary prevention training will be given after acute myocardial infarction
Primary Outcome Measure Information:
Title
means of subjective anxiety scores
Description
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
Time Frame
six months
Title
means of subjective quality of life scores
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
means of subjective pain score
Description
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.
Time Frame
six months
Other Pre-specified Outcome Measures:
Title
means of blood pressure (mmHg)
Description
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.
Time Frame
six months
Title
means of total cholesterol (mg/dl)
Description
The values measured during routine blood checks will be taken for cholesterol values in this study.
Time Frame
six months
Title
means of HDL cholesterol (mg/dl)
Description
The values measured during routine blood checks will be taken for cholesterol values in this study.
Time Frame
six months
Title
means of LDL cholesterol (mg/dl)
Description
The values measured during routine blood checks will be taken for cholesterol values in this study.
Time Frame
six months
Title
means of triglyceride (mg/dl)
Description
The values measured during routine blood checks will be taken for cholesterol values in this study.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
saadet can çiçek, doctoral lecturer
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant İzzet Baysal University
City
Merkez
State/Province
Bolu
ZIP/Postal Code
14100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Secondary Prevention Education After Acute Myocardial Infarction

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