- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367906
Digital Microlearning and Patient Safety in Nursing Students (DigiM-2026)
Effect of Digital Microlearning on Patient Safety Awareness and Clinical Decision-Making Among Nursing Students Before Surgical Clinical Practice: A Randomized Controlled Trial
This randomized controlled study aims to evaluate the effect of a patient safety-focused digital microlearning program on nursing students before they begin surgical clinical practice.
Nursing students often face challenges related to patient safety and clinical decision-making during the transition from classroom learning to clinical settings. This study will examine whether short, structured digital learning modules can improve patient safety awareness, recognition of clinical errors, and decision-making skills.
Second-year undergraduate nursing students will be randomly assigned to either a digital microlearning intervention group or a control group receiving standard education. Outcomes will be measured before the intervention, immediately after the intervention, and during the first week of clinical practice.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The transition from preclinical education to clinical practice represents a critical period for patient safety among nursing students. During this phase, limited clinical experience combined with increased responsibility may increase the risk of errors related to patient safety and clinical decision-making. Educational strategies that strengthen patient safety awareness and cognitive readiness before clinical exposure are therefore essential.
This study is designed as a single-center, parallel-group, randomized controlled trial. It will be conducted at the Faculty of Health Sciences, Department of Nursing, Agri Ibrahim Cecen University. Participants will consist of second-year undergraduate nursing students who are preparing to begin surgical clinical practice for the first time.
After baseline assessment, eligible participants will be randomly assigned to either an intervention group or a control group using stratified randomization based on gender and grade point average. The intervention group will receive a patient safety-focused digital microlearning program delivered online for seven consecutive days. The program consists of short, scenario-based modules lasting approximately 3-5 minutes each and addresses topics such as patient safety risks, clinical error recognition, prioritization, and decision-making under stress. Participants will be able to access the modules flexibly within a daily time limit.
The control group will receive standard patient safety education as part of the undergraduate nursing curriculum without additional intervention.
Outcome measures will be collected at three time points: baseline prior to the intervention (T0), immediately after completion of the intervention (T1), and during the first week of surgical clinical practice (T2). Primary outcomes include changes in patient safety awareness and clinical error recognition performance. Secondary outcomes include clinical decision-making under stress, perceived readiness for clinical practice, self-confidence, and acceptability of the digital microlearning program.
This study involves an educational intervention only and does not include any invasive procedures, drugs, or medical devices. Participation is voluntary, and written informed consent will be obtained from all participants. The study has been submitted for ethical review and will be conducted in accordance with ethical principles for research involving human participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: VOLKAN GOKMEN, Assistant Professor
- Phone Number: +905327390938
- Email: vgokmen@agri.edu.tr
Study Locations
-
-
Merkez
-
AĞRI, Merkez, Turkey (Türkiye), 04100
- Recruiting
- Agri Ibrahim Cecen University Faculty of Health Sciences
-
Contact:
- VOLKAN GOKMEN, Assist. Prof.
- Phone Number: +905327390938
- Email: vgokmen@agri.edu.tr
-
Contact:
- BURCU DEMIR GOKMEN, Assoc. Prof.
- Phone Number: +905067516888
- Email: budemir@agri.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Second-year undergraduate nursing students
- Enrolled in the Faculty of Health Sciences, Department of Nursing
- Preparing to begin surgical clinical practice for the first time
- Aged 18 years or older
- Willing to participate and able to provide written informed consent
Exclusion Criteria:
- Previous surgical clinical practice experience
- Previous professional nursing or healthcare work experience
- Incomplete baseline assessment
- Declining to participate or withdrawal of consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital Microlearning Intervention Group
Participants in this group will receive a patient safety-focused digital microlearning program before starting surgical clinical practice.
|
A structured digital microlearning program consisting of short, scenario-based modules (3-5 minutes each) focusing on patient safety awareness, clinical error recognition, prioritization, and clinical decision-making.
The program will be delivered online for seven consecutive days before surgical clinical practice.
|
|
No Intervention: Control Group Standard Education
Participants in this group will receive standard patient safety education as part of the undergraduate nursing curriculum without additional intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Safety Awareness
Time Frame: Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice
|
Change in patient safety awareness assessed using the Patient Safety Awareness Questionnaire, which evaluates students' understanding of patient safety principles, risk recognition, and safe clinical practices in surgical care.
Outcome Measure: Total score on the Patient Safety Awareness Questionnaire, ranging from 0 to 100, where higher scores indicate greater patient safety awareness.
|
Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice
|
|
Clinical Error Recognition Performance
Time Frame: Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice
|
Change in clinical error recognition performance assessed using scenario-based clinical error recognition tests evaluating students' ability to identify patient safety risks and potential clinical errors.
Outcome Measure: Total score on the Clinical Error Recognition Test, ranging from 0 to 100, where higher scores indicate better clinical error recognition performance.
|
Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Decision-Making Under Stress
Time Frame: Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice
|
Change in clinical decision-making performance under stress assessed using scenario-based decision-making evaluations simulating stressful surgical clinical situations.
Outcome Measure: Total score on the Clinical Decision-Making Under Stress Assessment, ranging from 0 to 100, where higher scores indicate better clinical decision-making performance under stress.
|
Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice
|
|
Perceived Readiness and Self-Confidence for Clinical Practice
Time Frame: Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice
|
Change in perceived readiness and self-confidence for surgical clinical practice measured using the Clinical Practice Readiness and Self-Confidence Scale.
Outcome Measure: Total score on the Clinical Practice Readiness and Self-Confidence Scale, ranging from 1 to 5, where higher scores indicate greater perceived readiness and self-confidence.
|
Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice
|
|
Acceptability of the Digital Microlearning Program
Time Frame: Post-intervention (T1): Within 1 week after completion of the intervention
|
Participant satisfaction and perceived usefulness of the digital microlearning program assessed using a post-intervention program acceptability questionnaire in the intervention group.
Outcome Measure: Total score on the Program Acceptability Questionnaire, ranging from 1 to 5, where higher scores indicate greater acceptability and perceived usefulness.
|
Post-intervention (T1): Within 1 week after completion of the intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- World Health Organization. Patient safety curriculum guide: Multi-professional edition. Geneva: WHO; 2011.
- Lee SE, Morse BL, Kim NW. Patient safety educational interventions: A systematic review with recommendations for nurse educators. Nurs Open. 2022 Jul;9(4):1967-1979. doi: 10.1002/nop2.955. Epub 2021 May 28.
- De Gagne JC, Park HK, Hall K, Woodward A, Yamane S, Kim SS. Microlearning in Health Professions Education: Scoping Review. JMIR Med Educ. 2019 Jul 23;5(2):e13997. doi: 10.2196/13997.
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
- Digital Microlearning-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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