Coronary Artery DiseaseNCT06174090
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
A study testing Coronary bypass graft surgery video education in people with Coronary Artery Disease, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this research to examine the effectiveness of video-education on pain, anxiety, and knowledge levels on adult patients undergoing coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary bypass graft surgery video education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2023to 31 Mar 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being at least 18 years old
- Being hospitalized in Cardiovascular Surgery Clinic and Cardiovascular surgery intensive care unit
- Undergoing coronary artery bypass graft surgery for the first time, by sternotomy method
- Patients who agree to participate in the research and read and sign the "Informed Volunteer Consent Form for Scientific Research"
Who cannot join
- Patients with visual or hearing impariment
- Patients with psychiatric illness,
- Patients with known cognitive impairment (dementia, Alzheimer's).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University Faculty of Health Sciences
Ankara, Etimesgut, 06790
Gülçin Şahin, MSc, RN, +905319901871, gulcinnn.sahin@gmail.com
Nalan Özhan Elbaş, Prof., +903122466666 ext. 1596, nelbas@baskent.edu.tr
About this study
Official title: The Effect of Patient Education With Video Prior to Coronary Artery Bypass Graft Surgery on Pain, Anxiety and Knowledge Levels of Patients
The aim of this research to examine the effectiveness of video-education on pain, anxiety, and knowledge levels on adult patients undergoing coronary artery bypass graft surgery.
Read the detailed description
A video based patient education will be used in this randomized controlled study. Patient education via video aims to reduce the patient's anxiety levels, control their pain, and improve their health outcomes by increasing knowledge levels. In addition, since this training is visual-based, it is aimed to provide effective learning by reducing the inequality due to sociodemographic and individual differences between participants. The video-education includes information about pre and post-surgical process and care.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary bypass graft surgery video education
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary bypass graft surgery video educationOther
It includes information about surgical process and handling issues within the first few days of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Video-education | Experimental | Participants will receive video-education about bypass surgery care, the day before the surgery, for once. Receives: Other: Coronary bypass graft surgery video education |
| Control | No intervention | Participants will receive verbal education about bypass surgery care, the day before the surgery, once |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Visual analog scale (VAS): VAS is a widely used scale for pain assessment. The scale was developed by Albersnagel, and its validity and reliability in our country were established by Aydin et al. In VAS, pain averages ranging from 0 to 10 are given on a 10 cm scale. Accordingly, while "0" indicates no pain, an average VAS value of "1-4" indicates mild pain, "5-6" indicates moderate pain, and "7-10" indicates severe. Change= VAS score of video-education group<standard verbal education.on 24th, 48th, and 72nd hours after surgery
Measured: from 24th of surgery to 72nd hour
Anxiety level
State anxiety scale (STAI-I): The scale determines how the individual feels at a certain moment, in a certain condition, and his/her emotions regarding the situation. The total score obtained from the scale is between 20-80. A high score indicates a high level of anxiety. The feelings and behaviors expressed in the State Anxiety Scale items are answered by marking one of the following conditions, such as (1) not at all, (2) a little, (3) a lot and (4) completely, according to the severity of such experiences. Change= STAI-I score of video-education group<standard verbal education.on pre-and-post education, and on 72nd hours after surgery.
Measured: from baseline prior to education to 72nd hour of surgery
Preoperative anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS): The scale is one of the scales used to evaluate preoperative anxiety. Source of anxiety; It is divided into three: due to surgery, anesthesia or lack of information. It contains 6 statements regarding these three sources to assess anxiety. In order to objectify the survey, each statement is given a numerical value based on a 5-point Likert scale according to severity; These values, ranging from 1 to 5; 1=none, 2=mild, 3=moderate, 4=severe, 5=extreme severity. Higher score means higher preoperative anxiety. Change= APAIS score of video-education group<standard verbal education n pre-and-post education, and on 72nd hours after surgery.
Measured: from baseline prior to education to 72nd hour of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start5 Sep 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will watch a 12-minute video-education about pre-post surgical process and care in bypass surgery, for once the day before surgery. Video-education was created by the researcher based on the literature. Expert opinion was provided related to content. The control group will receive standard verbal education lasting 12-minute about the issue.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulcin Sahin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174090
- Sponsor's protocol ID
- KA21/131
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for sharing IPD unless it is requested for a reasonable cause.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Education With Video Prior to Coronary Artery Bypass Graft Surgery on Pain, Anxiety and Knowledge Levels of Patients
- ClinicalTrials.gov ID
- NCT06174090
- Acronym / sponsor ID
- KA21/131
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 18 Dec 2023 (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 research to examine the effectiveness of video-education on pain, anxiety, and knowledge levels on adult patients undergoing coronary artery bypass graft surgery.
Detailed description
A video based patient education will be used in this randomized controlled study. Patient education via video aims to reduce the patient's anxiety levels, control their pain, and improve their health outcomes by increasing knowledge levels. In addition, since this training is visual-based, it is aimed to provide effective learning by reducing the inequality due to sociodemographic and individual differences between participants. The video-education includes information about pre and post-surgical process and care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group will watch a 12-minute video-education about pre-post surgical process and care in bypass surgery, for once the day before surgery. Video-education was created by the researcher based on the literature. Expert opinion was provided related to content. The control group will receive standard verbal education lasting 12-minute about the issue.
| Arm | Type | Receives |
|---|---|---|
| Video-education | Experimental | Other: Coronary bypass graft surgery video educationParticipants will receive video-education about bypass surgery care, the day before the surgery, for once. |
| Control | No intervention | –Participants will receive verbal education about bypass surgery care, the day before the surgery, once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being at least 18 years old
- Being hospitalized in Cardiovascular Surgery Clinic and Cardiovascular surgery intensive care unit
- Undergoing coronary artery bypass graft surgery for the first time, by sternotomy method
- Patients who agree to participate in the research and read and sign the "Informed Volunteer Consent Form for Scientific Research"
Key exclusion criteria (3 listed)
- Patients with visual or hearing impariment
- Patients with psychiatric illness,
- Patients with known cognitive impairment (dementia, Alzheimer's).
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 |
|---|---|---|
| Coronary bypass graft surgery video educationIt includes information about surgical process and handling issues within the first few days of surgery. | Other | Video-education |
Primary outcome
Pain Level
Time frame: from 24th of surgery to 72nd hour
Visual analog scale (VAS): VAS is a widely used scale for pain assessment. The scale was developed by Albersnagel, and its validity and reliability in our country were established by Aydin et al. In VAS, pain averages ranging from 0 to 10 are given on a 10 cm scale. Accordingly, while "0" indicates no pain, an average VAS value of "1-4" indicates mild pain, "5-6" indicates moderate pain, and "7-10" indicates severe. Change= VAS score of video-education group<standard verbal education.on 24th, 48th, and 72nd hours after surgery
Anxiety level
Time frame: from baseline prior to education to 72nd hour of surgery
State anxiety scale (STAI-I): The scale determines how the individual feels at a certain moment, in a certain condition, and his/her emotions regarding the situation. The total score obtained from the scale is between 20-80. A high score indicates a high level of anxiety. The feelings and behaviors expressed in the State Anxiety Scale items are answered by marking one of the following conditions, such as (1) not at all, (2) a little, (3) a lot and (4) completely, according to the severity of such experiences. Change= STAI-I score of video-education group<standard verbal education.on pre-and-post education, and on 72nd hours after surgery.
Preoperative anxiety
Time frame: from baseline prior to education to 72nd hour of surgery
Amsterdam Preoperative Anxiety and Information Scale (APAIS): The scale is one of the scales used to evaluate preoperative anxiety. Source of anxiety; It is divided into three: due to surgery, anesthesia or lack of information. It contains 6 statements regarding these three sources to assess anxiety. In order to objectify the survey, each statement is given a numerical value based on a 5-point Likert scale according to severity; These values, ranging from 1 to 5; 1=none, 2=mild, 3=moderate, 4=severe, 5=extreme severity. Higher score means higher preoperative anxiety. Change= APAIS score of video-education group<standard verbal education n pre-and-post education, and on 72nd hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No. There is no plan for sharing IPD unless it is requested for a reasonable cause.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary bypass graft surgery video education in people with Coronary Artery Disease, run by Baskent 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülçin Şahin, MSc (+905319901871, gulcinnn.sahin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: from 24th of surgery to 72nd hour). The study lists 3 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 18 Dec 2023.