An interventional study of Case-Based Collaborative Learning-Based Arrhythmia Education in Arrhythmia Recognition, Patient Safety Attitudes and Arrhythmia, sponsored by Naile ALANKAYA. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Naile ALANKAYA · Not applicable, Interventional, and Other
This randomized controlled trial evaluates the effectiveness of case-based collaborative learning (CBCL) in improving arrhythmia recognition and patient safety attitudes among novice intensive care nurses. Newly graduated nurses with less than one year of professional nursing experience working in coronary or cardiovascular surgery intensive care units are randomly assigned to an intervention or control group.
Both groups participate in the institution's routine orientation process for newly employed intensive care nurses. In addition, the intervention group receives a structured CBCL-based arrhythmia education program delivered in two 120-minute sessions over two consecutive weeks. The program uses clinical case scenarios, ECG tracings, individual assessment, small-group collaborative discussion, shared clinical decision-making, and structured feedback. The control group receives no additional study-specific arrhythmia education during the study period.
The primary outcome is arrhythmia recognition and awareness, and the secondary outcome is patient safety attitudes. Outcomes are assessed at baseline and at the three-month follow-up in both groups. An additional immediate post-intervention assessment is conducted in the intervention group to examine short-term changes following the educational program.
Early recognition and appropriate interpretation of cardiac arrhythmias are important competencies for nurses working in intensive care settings, where changes in cardiac rhythm may require rapid clinical assessment and timely escalation of care. Novice nurses may have limited opportunities to develop these competencies through clinical experience alone. This study therefore evaluates a case-based collaborative learning (CBCL) approach designed to integrate arrhythmia recognition with clinical reasoning, nursing decision-making, and patient-safety principles.
The CBCL intervention uses clinically oriented arrhythmia scenarios accompanied by ECG tracings. Participants first assess each case individually and then work in small groups to discuss their interpretations and reach a shared clinical decision. Group conclusions are subsequently discussed with the educator, who facilitates analysis of the case, clarification of misconceptions, and structured feedback. Patient-safety principles, including recognition of hemodynamic instability, timely escalation of care, differentiation of true arrhythmias from monitoring artefacts, and assessment of the patient's clinical condition, are integrated throughout the educational activities.
The main effectiveness evaluation compares the intervention and control groups at the three-month follow-up while accounting for baseline outcome levels. An additional assessment immediately after completion of the educational program is conducted only in the intervention group to explore the immediate educational response and whether the observed improvement is maintained at three months.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 72 is below the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Naile ALANKAYA is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the institution's routine orientation for newly employed intensive care nurses in addition to a structured case-based collaborative learning (CBCL) program focused on arrhythmia recognition, ECG interpretation, clinical decision-making, and patient safety. The CBCL program consists of two 120-minute sessions delivered over two consecutive weeks. Each session incorporates clinical case scenarios, ECG tracings, individual assessment, small-group collaborative discussion, shared clinical decision-making, facilitator-guided analysis, and structured feedback.
Behavioral: Case-Based Collaborative Learning-Based Arrhythmia Education
Participants undergo the institution's routine orientation process for newly employed intensive care nurses and continue their usual clinical practice. They receive no study-specific CBCL intervention or additional arrhythmia-focused education from the research team during the study period. After completion of the three-month follow-up and final data collection, participants in the control group are offered the same arrhythmia education program.
The intervention consists of two 120-minute educational sessions delivered once weekly over two consecutive weeks by a researcher with formal ECG training and certification in ECG interpretation. Each session uses clinically oriented arrhythmia cases accompanied by ECG tracings. Participants first assess the case individually and then work in small groups of 5-6 nurses to discuss their interpretations and reach a shared clinical decision. Groups present their conclusions, followed by facilitator-guided whole-group analysis, clarification of misconceptions, and structured feedback. The program addresses ECG interpretation, life-threatening rhythms, bradyarrhythmias, atrioventricular blocks, atrial tachyarrhythmias, medication- and electrolyte-related ECG changes, QT prolongation, and monitoring problems. Patient-safety principles and appropriate nursing responses and escalation of care are integrated throughout the cases.
Also known as: CBCL-Based Arrhythmia Education
Arrhythmia Recognition and Awareness Test (ARAT)
The Arrhythmia Recognition and Awareness Test (ARAT) consists of 27 items assessing arrhythmia recognition and awareness. Each correct response is scored as 1 and each incorrect response as 0, yielding a total score ranging from 0 to 27. Higher scores indicate better arrhythmia recognition and awareness.
Time frame: Baseline and 3 months after randomization
Safety Attitudes Questionnaire (SAQ)
The Safety Attitudes Questionnaire (SAQ) is used to assess participants' attitudes toward patient safety. The questionnaire includes 46 items rated on a 5-point Likert scale and comprises six dimensions: teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions. Higher scores indicate more positive attitudes toward patient safety.
Time frame: Baseline and 3 months after randomization
Plan to share: No — Individual participant data will not be made publicly available because the informed consent obtained from participants did not specifically include provisions for public sharing of individual-level data. Aggregated study findings will be reported in scientific publications.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
Of 171 non-industry interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 4 months is below that.
Counting every sponsor, half of 242 studies reached it within 24 months; a quarter within 12 and three quarters within 40.
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