CClinicalTrials.gg
CompletedNCT04769219Updated Jan 2, 2024

Secondary Prevention Education After Acute Myocardial Infarction

An interventional study of Secondary prevention training in Myocardial Infarction, Acute, Anxiety and Education, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-02.

Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2020, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myocardial Infarction, Acute
  • Anxiety
  • Education
  • Quality of Life

Keywords

  • myocardial infarction
  • anxiety
  • education
  • Quality of Life
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 86 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
86 participants (actual)

Study arms

  • 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.

    Other: Secondary prevention training

  • 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.

Interventions

  • OtherSecondary prevention training

    Secondary prevention training will be given after acute myocardial infarction

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: six months

  2. 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.

    Time frame: six months

Secondary outcomes

  1. 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.

    Time frame: six months

Other outcomes

  1. 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.

    Time frame: six months

  2. means of total cholesterol (mg/dl)

    The values measured during routine blood checks will be taken for cholesterol values in this study.

    Time frame: six months

  3. means of HDL cholesterol (mg/dl)

    The values measured during routine blood checks will be taken for cholesterol values in this study.

    Time frame: six months

  4. means of LDL cholesterol (mg/dl)

    The values measured during routine blood checks will be taken for cholesterol values in this study.

    Time frame: six months

  5. means of triglyceride (mg/dl)

    The values measured during routine blood checks will be taken for cholesterol values in this study.

    Time frame: six months

07

Study locations

1 site
  • Abant İzzet Baysal University
    Merkez, Bolu 14100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04769219
Lead sponsor
Abant Izzet Baysal University
Responsible party
Sponsor
First posted
Feb 24, 2021
Start date
Mar 1, 2020
Primary completion
Mar 1, 2021
Completion
Aug 31, 2021
Last update
Jan 2, 2024

Study contacts

saadet can çiçek, Dr
principal investigator · Abant Izzet Baysal University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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