- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07503678
CABG-AI-Supported Discharge Education (AI-D-E-CABG)
The Effect of Artificial Intelligence-Supported Individualized Discharge Education on Postoperative Pain, Anxiety, Stress Response, Recovery, and Discharge Education Satisfaction in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Coronary artery bypass graft (CABG) surgery is a major cardiac procedure that requires structured discharge education to support patients' physical, psychological, and behavioral recovery after hospitalization. Traditional discharge teaching provided by nurses is often limited by time constraints, varying patient needs, and inconsistent information delivery. Recent advances in artificial intelligence (AI) offer new opportunities to provide individualized, understandable, and repetitive patient education that may enhance postoperative recovery.
This randomized controlled trial aims to evaluate the effectiveness of AI-supported individualized discharge education for patients undergoing CABG surgery. The intervention consists of a personalized discharge education script generated by an advanced large-language-model system (ChatGPT), structured according to 6 main topics and 24 sub-domains, and then converted into a nurse-avatar video. Patients in the intervention group will receive this AI-supported education in addition to the standard verbal discharge education provided by cardiovascular surgery nurses. Patients in the control group will receive only the standard discharge education based on current hospital protocols.
The study will assess multiple postoperative outcomes, including pain intensity, anxiety levels, physiological stress response (cortisol, adrenaline, noradrenaline, ACTH, glucose, and insulin), recovery after discharge using a validated surgical recovery scale, and satisfaction with discharge education. Measurements will be collected at four time points: the day before discharge, the morning of discharge before education, immediately after the completion of discharge education, and at the routine postoperative follow-up visit.
A total of 128 participants will be randomized into two groups using block randomization stratified by sex. All data will be collected using validated scales and standardized laboratory procedures. This study is expected to provide evidence on whether AI-supported discharge education can improve postoperative recovery, reduce stress and anxiety, and increase satisfaction among CABG patients. The results may contribute to the development of innovative, technology-enhanced education models for surgical patients and support the integration of AI tools into nursing practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Uğur Akman, RN, MSc
- Phone Number: +905428155049
- Email: ugurkman@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who have undergone coronary artery bypass graft (CABG) surgery.
- Age 18 years or older.
- Hemodynamically stable at the time of enrollment.
- Able to understand and communicate in Turkish.
- Able to use or have access to a mobile phone capable of viewing the educational video.
- Able to provide informed consent.
- Scheduled for routine postoperative follow-up at the study hospital.
Exclusion Criteria:
- Patients undergoing emergency CABG surgery.
- Presence of severe cognitive impairment that prevents understanding or following instructions.
- Diagnosed psychiatric disorders (e.g., schizophrenia, severe depression) that interfere with study participation.
- Severe vision or hearing impairment that prevents receiving the education.
- Presence of postoperative complications requiring intensive care readmission.
- Patients with endocrine disorders affecting stress biomarkers (e.g., Cushing's syndrome, Addison's disease).
- Chronic use of corticosteroids or medications that significantly alter cortisol levels.
- Patients who decline to participate or withdraw consent.
- Patients who are unable to complete follow-up assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI-Supported Discharge Education
Participants in this arm will receive individualized discharge education generated by an artificial intelligence system (ChatGPT) and delivered through a nurse-avatar video.
This education covers 6 main topics and 24 subcomponents tailored to the patient's clinical, social, and psychosocial characteristics.
Participants will also receive the standard verbal discharge education routinely provided by cardiovascular surgery nurses.
|
This intervention consists of personalized discharge education generated by an advanced artificial intelligence system (ChatGPT) based on the patient's clinical, social, and psychosocial characteristics.
The content is structured into 6 main topics and 24 sub-sections.
The script is converted into a nurse-avatar video and delivered to the patient via a mobile device.
This intervention is provided in addition to the standard verbal discharge education routinely given by cardiovascular surgery nurses.
This intervention consists of routine verbal discharge education provided by cardiovascular surgery nurses according to standard hospital protocols.
It includes essential postoperative instructions, medication guidance, wound care instructions, activity recommendations, and follow-up information.
No AI-generated or video-based educational materials are provided in this intervention.
|
|
Active Comparator: Standard Discharge Education
Participants in this arm will receive only the standard verbal discharge education routinely provided by cardiovascular surgery nurses, based on hospital discharge protocols.
No AI-generated or video-based educational materials will be used in this group.
|
This intervention consists of routine verbal discharge education provided by cardiovascular surgery nurses according to standard hospital protocols.
It includes essential postoperative instructions, medication guidance, wound care instructions, activity recommendations, and follow-up information.
No AI-generated or video-based educational materials are provided in this intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Anxiety will be measured using a 10-cm Visual Analog Scale (VAS).
Participants will indicate their perceived level of anxiety on a horizontal line ranging from 0 to 10, where 0 represents "no anxiety" and 10 represents "the highest possible level of anxiety."
The score is obtained by measuring the distance in centimeters from the left end of the scale to the participant's mark, producing a continuous value between 0 and 10.
Higher scores indicate higher levels of anxiety.
This measure allows for sensitive detection of changes in anxiety over time.
No threshold or categorical classification is used; all results are reported as continuous VAS scores.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
|
Anxiety Level
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Anxiety will be assessed using the Visual Analog Scale (VAS).
The scale ranges from 0 to 10, where higher scores indicate greater anxiety levels.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
|
Serum Cortisol Level
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Physiological stress will be evaluated by measuring serum cortisol levels obtained from venous blood samples.
Higher cortisol levels indicate increased physiological stress response.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
|
Postoperative Recovery
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Postoperative recovery will be evaluated using a validated postoperative recovery scale assessing physical, emotional, and functional recovery.
Higher scores indicate better postoperative recovery.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
|
Satisfaction with Discharge Education
Time Frame: Pre-discharge (within 24 hours before discharge) and 4 weeks (±3 days) post-discharge
|
Satisfaction with discharge education will be measured using a validated satisfaction scale assessing patients' satisfaction with the information received before discharge.
Higher scores indicate greater satisfaction.
|
Pre-discharge (within 24 hours before discharge) and 4 weeks (±3 days) post-discharge
|
|
Blood Pressure - Systolic
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Systolic blood pressure will be measured using a calibrated clinical blood pressure monitor and recorded in mmHg.
Higher values indicate higher arterial pressure during cardiac contraction.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
|
Blood Pressure - Diastolic
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Diastolic blood pressure will be measured using a calibrated clinical blood pressure monitor and recorded in mmHg.
Higher values indicate arterial pressure during cardiac relaxation.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
|
Respiratory Rate
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Respiratory rate will be measured by counting the number of chest rises over one minute and recorded as breaths per minute (breaths/min).
Higher values indicate increased respiratory effort or possible respiratory distress.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
|
Oxygen Saturation (SpO₂)
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Oxygen saturation will be measured using pulse oximetry and recorded as the percentage of oxygen-saturated hemoglobin in arterial blood.
Lower values indicate impaired oxygenation.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
|
Body Temperature
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Body temperature will be measured using a digital thermometer and recorded in degrees Celsius (°C).
Deviations from normal temperature may indicate infection or inflammatory response.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Heart rate will be measured using a clinical monitor and recorded in beats per minute (bpm).
Higher values indicate increased cardiac activity.
|
Baseline (1 day before discharge), pre-discharge (within 24 hours before discharge), and 4 weeks (±3 days) post-discharge
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ronaldson S., et al. (2022). Patient-centered education in postoperative cardiac care: A systematic review. Heart & Lung, 55, 54-62.
- Akbari M., Çelik S. (2015). Effects of nurse-led discharge training on anxiety and recovery in surgical patients. Journal of Perioperative Nursing, 28(4), 215-223.
- Minami K., et al. (2020). Effects of discharge education on postoperative recovery in cardiac surgery patients. European Journal of Cardiovascular Nursing, 19(7), 660-668.
- Hwang B., et al. (2023). Artificial intelligence in patient education: A scoping review. Patient Education and Counseling, 112, 107-115.
- Fredericks S., Guruge S. (2012). Postoperative patient education: A systematic review. Clinical Nursing Research, 21(4), 379-402. doi:10.1177/1054773812440814
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBUVAN-KABG-AI-DISCHARGE-EDU-0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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