Myocardial Infarction, AcuteNCT04769219
Secondary Prevention Education After Acute Myocardial Infarction
A study testing Secondary prevention training in people with Myocardial Infarction, Acute and Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Acute, Anxiety, Education
- What is being tested?
- Secondary prevention training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant İzzet Baysal University
Merkez, Bolu, 14100
About this study
Official title: 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.
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.
- Conditions
- Myocardial Infarction, Acute, Anxiety, Education, Quality of Life
- Being tested
- Secondary prevention training
- Keywords
- myocardial infarction, anxiety, education, Quality of Life
- Medical subject headings
- Myocardial Infarction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary prevention trainingOther
Secondary prevention training will be given after acute myocardial infarction
| Study group | Role | What they receive |
|---|---|---|
| secondary prevention training | Experimental | 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. Receives: Other: Secondary prevention training |
| nursing care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six months
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.
Measured: 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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups as intervention and control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- saadet can çiçek, Dr, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769219
- Sponsor's protocol ID
- AIBU-KYB-AYN-02
- Status last verified
- Dec 2023
- First submitted
- 21 Feb 2021
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Secondary Prevention Education Given to Individuals After Acute Myocardial Infarction on Physiological Parameters, Anxiety and Quality of Life
- ClinicalTrials.gov ID
- NCT04769219
- Acronym / sponsor ID
- AIBU-KYB-AYN-02
- Conditions
- Myocardial Infarction, Acute, Anxiety, Education, Quality of Life
- Keywords
- myocardial infarction, anxiety, education, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are 2 groups as intervention and control
| Arm | Type | Receives |
|---|---|---|
| secondary prevention training | Experimental | Other: Secondary prevention trainingSecondary 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. |
| nursing care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secondary prevention trainingSecondary prevention training will be given after acute myocardial infarction | Other | secondary prevention training |
Primary outcome
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
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.
1 secondary outcome
means of subjective pain score
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
saadet can çiçek, Dr principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secondary prevention training in people with Myocardial Infarction, Acute and Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
means of subjective anxiety scores (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.