Coronary AngiographyNCT05160935
Effect of the Education Given to the Patients Who Will Be Applied Coronary Angiography
A study testing Education in people with Coronary Angiography and Anxiety, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This research; The aim of this study was to evaluate the effect of the pre-procedural education given to the patients undergoing coronary angiography on the anxiety level and vital signs of the patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Angiography, Anxiety, Vital Signs
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having at least literate education level,
- 18 years old or older,
- No communication problems,
- Does not have mental or psychiatric disease,
- Agreeing to participate in the study voluntarily,
- Individuals who will undergo coronary angiography for the first time.
Who cannot join
- Being illiterate
- Being under the age of 18
- Having any communication problem,
- Having mental or psychiatric disease,
- Not wanting to participate in the study,
- Individuals who have undergone coronary angiography before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Anxiety Level and the Effect on Vital Signs of the Education Given to the Patients Who Will Be Applied Coronary Angiography
This research; The aim of this study was to evaluate the effect of the pre-procedural education given to the patients undergoing coronary angiography on the anxiety level and vital signs of the patients.
Read the detailed description
Coronary Artery Disease is a vascular disease in the category of atherosclerosis, which is characterized by complete or partial occlusion of the arteries, providing oxygen-rich blood to meet the metabolic needs of the heart. It was shown as the top 10 causes of death worldwide in 2017 by the World Health Organization. According to the 2018 data of the Turkish Statistical Institute (TUIK), it has been reported that 39.7% of the deaths caused by the circulatory system in Turkey are due to heart diseases. Coronary angiography, which is among the diagnostic methods of coronary artery disease; It is the process of evaluating the coronary arteries by making them visible by administering radiopaque material to the femoral, brachial, radial and axillary arteries during cardiac catheterization. One of the basic roles of nursing is to provide education for the recovery of the individual and the maintenance of health. In this context, it is thought that nurses' caring about the role of educator in patient care will contribute to reducing the patient's anxiety.
Research; This study was planned to evaluate the effect of pre-procedural education on patients undergoing coronary angiography on their anxiety level and vital signs.
The research was planned as a quasi-experimental study with pretest-posttest control group design between November 2021 and June 2022. The population of all patients who underwent coronary angiography in the Cardiology Service of Eskişehir City Hospital, the sample was calculated using the G-Powr 3.1 program and it was found appropriate to include 79 people in each group with a 95% CI 90% power. The "Simple Randomization Method" will be used to divide the individuals who agree to participate in the research into the experimental and control groups. Since the individuals in the sample group will share the same environment, the experimental group will be included in data collection on even days and the control group on odd days. A "Diagnostic Form" will be filled in for all patients in the sample, their vital signs will be evaluated, and the "State-Trait Anxiety Inventory" will be administered. For the patients in the experimental group; Before the coronary angiography procedure, training will be given by using the "Training Booklet" prepared by the researchers in line with the literature and the opinion of the specialist physician. After the coronary angiography procedure, the "State-Trait Anxiety Inventory" will be re-administered to the patients and their vital signs will be followed. In the control group; Before the coronary angiography procedure, verbal information will be given for the coronary angiography procedure within the scope of the routine procedure in the clinic, in line with the information in the patient consent form. After the procedure, the State-Trait Anxiety Inventory will be applied again. Vital signs will be monitored. The obtained data will be evaluated with appropriate statistical methods.
As a result of the research, it is thought that the questions of whether the education given to the patients who will undergo coronary angiography have an effect on reducing the anxiety levels of the patients and have a positive effect on the vital signs values will be answered.
Keywords: Coronary angiography, anxiety, vital signs, education, nursing, nursing care
This research; The aim of this study was to evaluate the effect of the pre-procedural education given to the patients undergoing coronary angiography on the anxiety level and vital signs of the patients.
Research Questions;
- Does the training given to the patients who will undergo coronary angiography have an effect on the anxiety level of the patients?
- Does the training given to the patients who will undergo coronary angiography have a positive effect on the vital signs of the patients?
- Conditions
- Coronary Angiography, Anxiety, Vital Signs, Education, Nursing, Nursing Care
- Being tested
- Education
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Each patient will be informed about the study, and written consent will be obtained from patients who agree to participate in the study, explaining the purpose and duration of the study. A Patient Identification Form will be filled, the patient's vital signs will be evaluated, and the State-Trait Anxiety Inventory will be administered to the patient.
Before the coronary angiography procedure, the patients in the experimental group will be trained by the researchers using the training booklet. Trait Anxiety Inventory will be re-administered to the patients after the procedure. Vital signs of patients will be monitored.
In the control group; In line with the information in the patient consent form before the coronary angiography procedure, verbal information will be given about the coronary angiography procedure within the scope of the routine procedure in the clinic. After the procedure, the State-Trait Anxiety Inventory will be applied again. Vital signs will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Angiography Training Manual | Experimental | It is the form prepared by the researchers in line with the literature information and the opinion of the specialist physician was taken. It contains information about coronary artery disease, what to do before coronary angiography procedure and what kind of situations await individuals after the procedure. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has an effect on reducing the anxiety levels of the patients".
"State-Trait Anxiety Inventory" will be applied to the patient in the experimental group before the coronary angiography procedure. Then, coronary angiography information training will be given using the Coronary Angiography Training Guide tool. After the angiography procedure, "State-Trait Anxiety Inventory" will be applied again. State-Trait Anxiety Inventory: The inventory includes two separate scales consisting of a total of forty items (twenty items in each scale). For both scales; 0-19 points (absent), 20-39 points (mild), 40-59 points (moderate), 60-79 points (severe), 80 points and above are considered as very severe panic. Both scales have direct and reversed statements. In the State Anxiety Inventory, there are ten in total (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) and in the Trait Anxiety Inventory seven (21, 26, 27, 30, 33, 36, 39) There are reversed statements.
Measured: 8 weeks
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the blood pressure (mm-Hg) level, one of the vital signs values of the patients".
The blood pressure (mm-Hg) of the patient in the experimental group before the coronary angiography procedure will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's blood pressure (mm-Hg) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. The blood pressure value that is considered normal is 120/80 mm-Hg, with an upper limit of 139/89 mm-Hg.
Measured: 8 weeks
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the heart rate (beats/min) level, which is one of the vital signs values of the patients".
Before the coronary angiography procedure of the patient in the experimental group, the heart rate (beats/min) will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given as audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's heart rate (beats/min) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated with appropriate statistical methods. The normal range of pulse rate; 60-100 beats/min.
Measured: 8 weeks
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the vital signs of the patients, the respiratory rate (respiratory rate/min)".
The respiratory rate (respiratory rate/min) of the patient in the experimental group before the coronary angiography procedure will be measured and recorded by the nurse. Later, coronary angiography information training will be given audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's respiratory rate (respiratory rate/min) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. The normal range of respiratory rate; 12-20 ventilation/min.
Measured: 8 weeks
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the vital signs values of the patients and the body temperature (°C) level".
Before the coronary angiography procedure of the patient in the experimental group, the body temperature (°C) will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given as audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's body temperature (°C) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. The range of body temperature considered normal; 36°C - 38°C
Measured: 8 weeks
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the oxygen saturation (SpO2) level, one of the vital signs values of the patients".
Before the coronary angiography procedure of the patient in the experimental group, the oxygen saturation (SpO2) will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given as audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the patient's coronary angiography procedure, the oxygen saturation (SpO2) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. Oxygen saturation (SpO2) is within the considered normal range; 93-100 SpO2.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil PAMUK CEBECİ, Eskisehir Osmangazi University
- Investigators
- Sevil PAMUK CEBECİ, Study director, sevil.pamukcebeci@ogu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160935
- Sponsor's protocol ID
- 2021-1
- Status last verified
- Aug 2022
- First submitted
- 17 Nov 2021
- Last updated
- 19 Aug 2022
- Results posted
- 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 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anxiety Level and the Effect on Vital Signs of the Education Given to the Patients Who Will Be Applied Coronary Angiography
- ClinicalTrials.gov ID
- NCT05160935
- Acronym / sponsor ID
- 2021-1
- Conditions
- Coronary Angiography, Anxiety, Vital Signs, Education, Nursing, Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 16 Dec 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.
This research; The aim of this study was to evaluate the effect of the pre-procedural education given to the patients undergoing coronary angiography on the anxiety level and vital signs of the patients.
Detailed description
Coronary Artery Disease is a vascular disease in the category of atherosclerosis, which is characterized by complete or partial occlusion of the arteries, providing oxygen-rich blood to meet the metabolic needs of the heart. It was shown as the top 10 causes of death worldwide in 2017 by the World Health Organization. According to the 2018 data of the Turkish Statistical Institute (TUIK), it has been reported that 39.7% of the deaths caused by the circulatory system in Turkey are due to heart diseases. Coronary angiography, which is among the diagnostic methods of coronary artery disease; It is the process of evaluating the coronary arteries by making them visible by administering radiopaque material to the femoral, brachial, radial and axillary arteries during cardiac catheterization. One of the basic roles of nursing is to provide education for the recovery of the individual and the maintenance of health. In this context, it is thought that nurses' caring about the role of educator in patient care will contribute to reducing the patient's anxiety.
Research; This study was planned to evaluate the effect of pre-procedural education on patients undergoing coronary angiography on their anxiety level and vital signs.
The research was planned as a quasi-experimental study with pretest-posttest control group design between November 2021 and June 2022. The population of all patients who underwent coronary angiography in the Cardiology Service of Eskişehir City Hospital, the sample was calculated using the G-Powr 3.1 program and it was found appropriate to include 79 people in each group with a 95% CI 90% power. The "Simple Randomization Method" will be used to divide the individuals who agree to participate in the research into the experimental and control groups. Since the individuals in the sample group will share the same environment, the experimental group will be included in data collection on even days and the control group on odd days. A "Diagnostic Form" will be filled in for all patients in the sample, their vital signs will be evaluated, and the "State-Trait Anxiety Inventory" will be administered. For the patients in the experimental group; Before the coronary angiography procedure, training will be given by using the "Training Booklet" prepared by the researchers in line with the literature and the opinion of the specialist physician. After the coronary angiography procedure, the "State-Trait Anxiety Inventory" will be re-administered to the patients and their vital signs will be followed. In the control group; Before the coronary angiography procedure, verbal information will be given for the coronary angiography procedure within the scope of the routine procedure in the clinic, in line with the information in the patient consent form. After the procedure, the State-Trait Anxiety Inventory will be applied again. Vital signs will be monitored. The obtained data will be evaluated with appropriate statistical methods.
As a result of the research, it is thought that the questions of whether the education given to the patients who will undergo coronary angiography have an effect on reducing the anxiety levels of the patients and have a positive effect on the vital signs values will be answered.
Keywords: Coronary angiography, anxiety, vital signs, education, nursing, nursing care
This research; The aim of this study was to evaluate the effect of the pre-procedural education given to the patients undergoing coronary angiography on the anxiety level and vital signs of the patients.
Research Questions;
- Does the training given to the patients who will undergo coronary angiography have an effect on the anxiety level of the patients?
- Does the training given to the patients who will undergo coronary angiography have a positive effect on the vital signs of the patients?
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Angiography Training Manual | Experimental | Behavioral: EducationIt is the form prepared by the researchers in line with the literature information and the opinion of the specialist physician was taken. It contains information about coronary artery disease, what to do before coronary angiography procedure and what kind of situations await individuals after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having at least literate education level,
- 18 years old or older,
- No communication problems,
- Does not have mental or psychiatric disease,
- Agreeing to participate in the study voluntarily,
Key exclusion criteria (6 listed)
- Being illiterate
- Being under the age of 18
- Having any communication problem,
- Having mental or psychiatric disease,
- Not wanting to participate in the study,
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 |
|---|---|---|
| EducationEach patient will be informed about the study, and written consent will be obtained from patients who agree to participate in the study, explaining the purpose and duration of the study. A Patient Identification Form will be filled, the patient's vital signs will be evaluated, and the State-Trait Anxiety Inventory will be administered to the patient. Before the coronary angiography procedure, the patients in the experimental group will be trained by the researchers using the training booklet. Trait Anxiety Inventory will be re-administered to the patients after the procedure. Vital signs of patients will be monitored. In the control group; In line with the information in the patient consent form before the coronary angiography procedure, verbal information will be given about the coronary angiography procedure within the scope of the routine procedure in the clinic. After the procedure, the State-Trait Anxiety Inventory will be applied again. Vital signs will be taken. | Behavioural | Coronary Angiography Training Manual |
Primary outcome
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has an effect on reducing the anxiety levels of the patients".
Time frame: 8 weeks
"State-Trait Anxiety Inventory" will be applied to the patient in the experimental group before the coronary angiography procedure. Then, coronary angiography information training will be given using the Coronary Angiography Training Guide tool. After the angiography procedure, "State-Trait Anxiety Inventory" will be applied again. State-Trait Anxiety Inventory: The inventory includes two separate scales consisting of a total of forty items (twenty items in each scale). For both scales; 0-19 points (absent), 20-39 points (mild), 40-59 points (moderate), 60-79 points (severe), 80 points and above are considered as very severe panic. Both scales have direct and reversed statements. In the State Anxiety Inventory, there are ten in total (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) and in the Trait Anxiety Inventory seven (21, 26, 27, 30, 33, 36, 39) There are reversed statements.
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the blood pressure (mm-Hg) level, one of the vital signs values of the patients".
Time frame: 8 weeks
The blood pressure (mm-Hg) of the patient in the experimental group before the coronary angiography procedure will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's blood pressure (mm-Hg) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. The blood pressure value that is considered normal is 120/80 mm-Hg, with an upper limit of 139/89 mm-Hg.
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the heart rate (beats/min) level, which is one of the vital signs values of the patients".
Time frame: 8 weeks
Before the coronary angiography procedure of the patient in the experimental group, the heart rate (beats/min) will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given as audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's heart rate (beats/min) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated with appropriate statistical methods. The normal range of pulse rate; 60-100 beats/min.
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the vital signs of the patients, the respiratory rate (respiratory rate/min)".
Time frame: 8 weeks
The respiratory rate (respiratory rate/min) of the patient in the experimental group before the coronary angiography procedure will be measured and recorded by the nurse. Later, coronary angiography information training will be given audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's respiratory rate (respiratory rate/min) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. The normal range of respiratory rate; 12-20 ventilation/min.
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the vital signs values of the patients and the body temperature (°C) level".
Time frame: 8 weeks
Before the coronary angiography procedure of the patient in the experimental group, the body temperature (°C) will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given as audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the coronary angiography procedure, the patient's body temperature (°C) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. The range of body temperature considered normal; 36°C - 38°C
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has a positive effect on the oxygen saturation (SpO2) level, one of the vital signs values of the patients".
Time frame: 8 weeks
Before the coronary angiography procedure of the patient in the experimental group, the oxygen saturation (SpO2) will be measured and recorded by the nurse. Afterwards, coronary angiography information training will be given as audio-visual using the Coronary Angiography Training Guide tool. The patient will be prepared for the coronary angiography procedure. After the patient's coronary angiography procedure, the oxygen saturation (SpO2) will be measured and recorded by the nurse. Pre- and post-procedure scores will be evaluated using appropriate statistical methods. Oxygen saturation (SpO2) is within the considered normal range; 93-100 SpO2.
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 19 Aug 2022.
- 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.
Sevil PAMUK CEBECİ study director
sevil.pamukcebeci@ogu.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Coronary Angiography and Anxiety, run by Eskisehir Osmangazi 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 6 inclusion and 6 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 19 Aug 2022. 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?
To accept the hypothesis that "the education given to the patients who will undergo coronary angiography has an effect on reducing the anxiety levels of the patients". (time frame: 8 weeks). The study lists 6 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 19 Aug 2022.