- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04769219
Secondary Prevention Education After Acute Myocardial Infarction
December 29, 2023 updated by: Abant Izzet Baysal University
The Effect of Secondary Prevention Education Given to Individuals After Acute Myocardial Infarction on Physiological Parameters, Anxiety and Quality of Life
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bolu
-
Merkez, Bolu, Turkey, 14100
- Abant Izzet Baysal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: secondary prevention training
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.
|
Secondary prevention training will be given after acute myocardial infarction
|
No Intervention: nursing care
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
means of subjective anxiety scores
Time Frame: six months
|
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
|
means of subjective quality of life scores
Time Frame: six months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
means of subjective pain score
Time Frame: six months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
means of blood pressure (mmHg)
Time Frame: six months
|
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
|
means of total cholesterol (mg/dl)
Time Frame: six months
|
The values measured during routine blood checks will be taken for cholesterol values in this study.
|
six months
|
means of HDL cholesterol (mg/dl)
Time Frame: six months
|
The values measured during routine blood checks will be taken for cholesterol values in this study.
|
six months
|
means of LDL cholesterol (mg/dl)
Time Frame: six months
|
The values measured during routine blood checks will be taken for cholesterol values in this study.
|
six months
|
means of triglyceride (mg/dl)
Time Frame: six months
|
The values measured during routine blood checks will be taken for cholesterol values in this study.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: saadet can çiçek, Dr, Abant Izzet Baysal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
February 21, 2021
First Submitted That Met QC Criteria
February 21, 2021
First Posted (Actual)
February 24, 2021
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-KYB-AYN-02
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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