Health Knowledge, Attitudes, PracticeNCT07250451
Simulation Education and Clinical Practice on Nursing Students' Competence
A study testing Educational/training in people with Health Knowledge, Attitudes, Practice, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of integrated education, combining clinical practice and simulation laboratory training, on the competence of second-year undergraduate nursing students. This research is designed as a multi-crossover quasi-experimental randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Educational/training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergraduate nursing students enrolled in the second year of the program
- Willing to participate in the study
Who cannot join
- Students under 18 years of age
- Students who do not provide voluntary consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Multiple Scenarios Simulation Education And Clinical Practice On Nursing Students' Competence: Quasi Experimental Crossover Study
The aim of this study is to determine the effect of integrated education, combining clinical practice and simulation laboratory training, on the competence of second-year undergraduate nursing students. This research is designed as a multi-crossover quasi-experimental randomized controlled study. In this model, all groups were exposed to simulation training sessions in specific stages. This design is currently used in the clinical practice component of the Surgical Nursing course. Additionally, the researchers aimed to answer the question: "What is the most appropriate timing for simulation training to enhance nursing students' competence?"
During the clinical practice of the Surgical Diseases Nursing course, approximately 29-33 students participated in the simulation laboratory sessions, while about 61-65 students were involved in clinical field practice. For the simulation sessions, subgroups consisting of 4-5 students were formed. After each subgroup completed the simulation practice, a debriefing session was conducted. Each simulation scenario and related training lasted approximately half a day.
Read the detailed description
This study aims to evaluate the effect of integrating simulation-based laboratory sessions with clinical practice on the competence of second-year undergraduate nursing students enrolled in the Surgical Nursing course. The study was designed as a quasi-experimental, randomized, multi-crossover study model. In this design, all student groups were sequentially exposed to simulation-based training integrated within the clinical education process, allowing each group to experience both simulation and clinical practice in different sequences.
Setting
The laboratory environment was located on the first floor of the Faculty of Health Sciences. It was arranged as a patient room and equipped with two full-body low-fidelity mannequins and all necessary nursing materials for patient care. The lab had a capacity of 15-17 students and included a separate area with chairs and a whiteboard for debriefing and discussion sessions. Before each simulation, the environment and mannequins were prepared in accordance with the specific scenario. Simulation implementation and debriefing were conducted by the first author, while clinical practice supervision was carried out by the other three researchers.
Simulation Scenarios
A total of seven different low-fidelity simulation scenarios were used, including:
Preoperative preparation and postoperative care in colorectal surgery,
Postoperative care after subdural hematoma surgery,
Postoperative care after benign prostatic hyperplasia surgery,
Postoperative care after coronary bypass surgery,
Care of a patient with femur fracture,
Postoperative care after total laryngectomy.
All scenarios were developed based on the literature and reviewed by experts for content validity. Pilot testing was conducted during the previous academic year, and minor revisions were made based on feedback.
Briefing and Prebriefing
One week before each simulation, the theoretical content related to the upcoming scenario was taught to all students using traditional classroom instruction, and relevant course materials were provided. Students scheduled for the next simulation were informed of their specific scenario in advance and were asked to review the materials again. Prior to the simulation, the laboratory environment was introduced, and students were given 5-10 minutes to familiarize themselves with the setting. They were also informed that they could withdraw from the activity if they felt psychologically uncomfortable at any time.
Simulation Implementation
Students participated in groups of 4-5. Each group entered the lab as if entering a real patient room, greeted the patient (represented by the mannequin), and provided nursing care based on the patient's vital signs, lab results, and clinical complaints. In some scenarios, such as femur fracture care, complications like fat embolism were introduced to enhance realism. Students were expected to respond to these acute situations in addition to performing routine care. Each simulation lasted approximately 20-25 minutes. At the end of each scenario, students conducted patient handover to the next group (shift), ensuring continuity of care similar to real clinical practice. The patient's voice was provided by the first researcher.
Debriefing
Following each simulation, all four subgroups were brought together for a structured debriefing session based on the Gather-Analyze-Summarize (GAS) model. This session was designed to facilitate reflection, discussion of decision-making processes, and consolidation of learning outcomes.
Data were collected before and after the interventions using validated nursing competence measurement tools. The findings are expected to contribute to the optimization of simulation-based learning strategies in nursing education and to provide evidence for the effective timing and integration of simulation training within clinical education.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Educational/training
- Keywords
- nursing education, Simulation practice, nursing students
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational/trainingOther
Simulation-First Hybrid Training - Simulation → Clinical Practice:
Students first participated in four days of simulation in subgroups of 4-5, using low-fidelity mannequins for scenarios such as colorectal surgery care, subdural hematoma, BPH surgery, coronary bypass, femur fracture, and total laryngectomy. Prebriefing and debriefing (GAS method) were conducted. This was followed by eight days of clinical practice under faculty supervision.
Clinical Practice-Simulation-Clinical Practice (Integrated Training) - Clinical Practice → Simulation → Clinical Practice:
Students completed four days of clinical practice, four days of simulation as above, then four additional clinical practice days.
Clinical Practice-First Training Followed by Simulation - Clinical Practice → Simulation:
Students completed eight days of clinical practice followed by four days of simulation. Simulation sessions and clinical practice were conducted under faculty supervision.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-First Hybrid Training | Experimental | Students in Simulation-First Hybrid Training participated in four days of simulation-based training followed by eight days of clinical practice. Simulation sessions were conducted in subgroups of 4-5 students, followed by debriefing sessions. Clinical practice was conducted in hospital settings under faculty supervision. Receives: Other: Educational/training |
| Clinical Practice-Simulation-Clinical Practice (Integrated Training) | Experimental | Students in Clinical Practice-Simulation-Clinical Practice (Integrated Training) first completed four days of clinical practice, then four days of simulation-based training, followed by an additional four days of clinical practice. Simulation and clinical practice sessions were conducted as described for Simulation-First Hybrid Training. Receives: Other: Educational/training |
| Clinical Practice-First Training Followed by Simulation | Experimental | Students in Clinical Practice-First Training Followed by Simulation completed eight days of clinical practice, followed by four days of simulation-based training. Simulation and clinical practice sessions were conducted as described for Simulation-First Hybrid Training. Receives: Other: Educational/training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing Competence
The primary outcome is the level of nursing competence of second-year undergraduate nursing students, measured using a validated Nursing Competence Scale. Competence assessment includes clinical skills, decision-making, and ability to apply theoretical knowledge in simulation and clinical practice settings.
Measured: up to 12 weeks
Simulation Learning
Learning outcomes specific to simulation sessions were assessed using the Simulation Learning Evaluation Scale. This scale measures students' understanding, performance, and ability to apply skills in the simulated environment. Administered to each laboratory subgroup after simulation.
Measured: up to 12 weeks
Secondary outcomes (1)
Demographic Data
Demographic information including age, gender, and academic background was collected from all participants using a structured demographic form before clinical practice.
Measured: Baseline (pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Jan 2024
- Primary completion15 Jun 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study used a quasi-experimental, randomized, crossover design. All groups were exposed to both simulation-based training and clinical practice in different sequences. Each student participated in both intervention conditions at different time points, allowing within-subject comparison of competence outcomes. The study used a quasi-experimental, randomized, crossover design. After obtaining written consent, students who agreed to participate were stratified by gender and randomly assigned to one of three groups (A, B, or C) by a blinded faculty member to avoid allocation bias. Group A: Participated in four simulation days followed by eight clinical practice days. Group B: Completed four clinical practice days, then four simulation days, and finally four additional clinical practice days. Group C: Completed eight clinical practice days followed by four simulation days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiye Erbaş, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250451
- Sponsor's protocol ID
- DU-AE-01
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ndividual participant data will not be shared due to privacy and ethical considerations of student participation.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Multiple Scenarios Simulation Education And Clinical Practice On Nursing Students' Competence: Quasi Experimental Crossover Study
- ClinicalTrials.gov ID
- NCT07250451
- Acronym / sponsor ID
- DU-AE-01
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- nursing education, Simulation practice, nursing students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 26 Nov 2025 (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 study is to determine the effect of integrated education, combining clinical practice and simulation laboratory training, on the competence of second-year undergraduate nursing students. This research is designed as a multi-crossover quasi-experimental randomized controlled study. In this model, all groups were exposed to simulation training sessions in specific stages. This design is currently used in the clinical practice component of the Surgical Nursing course. Additionally, the researchers aimed to answer the question: "What is the most appropriate timing for simulation training to enhance nursing students' competence?"
During the clinical practice of the Surgical Diseases Nursing course, approximately 29-33 students participated in the simulation laboratory sessions, while about 61-65 students were involved in clinical field practice. For the simulation sessions, subgroups consisting of 4-5 students were formed. After each subgroup completed the simulation practice, a debriefing session was conducted. Each simulation scenario and related training lasted approximately half a day.
Detailed description
This study aims to evaluate the effect of integrating simulation-based laboratory sessions with clinical practice on the competence of second-year undergraduate nursing students enrolled in the Surgical Nursing course. The study was designed as a quasi-experimental, randomized, multi-crossover study model. In this design, all student groups were sequentially exposed to simulation-based training integrated within the clinical education process, allowing each group to experience both simulation and clinical practice in different sequences.
Setting
The laboratory environment was located on the first floor of the Faculty of Health Sciences. It was arranged as a patient room and equipped with two full-body low-fidelity mannequins and all necessary nursing materials for patient care. The lab had a capacity of 15-17 students and included a separate area with chairs and a whiteboard for debriefing and discussion sessions. Before each simulation, the environment and mannequins were prepared in accordance with the specific scenario. Simulation implementation and debriefing were conducted by the first author, while clinical practice supervision was carried out by the other three researchers.
Simulation Scenarios
A total of seven different low-fidelity simulation scenarios were used, including:
Preoperative preparation and postoperative care in colorectal surgery,
Postoperative care after subdural hematoma surgery,
Postoperative care after benign prostatic hyperplasia surgery,
Postoperative care after coronary bypass surgery,
Care of a patient with femur fracture,
Postoperative care after total laryngectomy.
All scenarios were developed based on the literature and reviewed by experts for content validity. Pilot testing was conducted during the previous academic year, and minor revisions were made based on feedback.
Briefing and Prebriefing
One week before each simulation, the theoretical content related to the upcoming scenario was taught to all students using traditional classroom instruction, and relevant course materials were provided. Students scheduled for the next simulation were informed of their specific scenario in advance and were asked to review the materials again. Prior to the simulation, the laboratory environment was introduced, and students were given 5-10 minutes to familiarize themselves with the setting. They were also informed that they could withdraw from the activity if they felt psychologically uncomfortable at any time.
Simulation Implementation
Students participated in groups of 4-5. Each group entered the lab as if entering a real patient room, greeted the patient (represented by the mannequin), and provided nursing care based on the patient's vital signs, lab results, and clinical complaints. In some scenarios, such as femur fracture care, complications like fat embolism were introduced to enhance realism. Students were expected to respond to these acute situations in addition to performing routine care. Each simulation lasted approximately 20-25 minutes. At the end of each scenario, students conducted patient handover to the next group (shift), ensuring continuity of care similar to real clinical practice. The patient's voice was provided by the first researcher.
Debriefing
Following each simulation, all four subgroups were brought together for a structured debriefing session based on the Gather-Analyze-Summarize (GAS) model. This session was designed to facilitate reflection, discussion of decision-making processes, and consolidation of learning outcomes.
Data were collected before and after the interventions using validated nursing competence measurement tools. The findings are expected to contribute to the optimization of simulation-based learning strategies in nursing education and to provide evidence for the effective timing and integration of simulation training within clinical education.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study used a quasi-experimental, randomized, crossover design. All groups were exposed to both simulation-based training and clinical practice in different sequences. Each student participated in both intervention conditions at different time points, allowing within-subject comparison of competence outcomes. The study used a quasi-experimental, randomized, crossover design. After obtaining written consent, students who agreed to participate were stratified by gender and randomly assigned to one of three groups (A, B, or C) by a blinded faculty member to avoid allocation bias. Group A: Participated in four simulation days followed by eight clinical practice days. Group B: Completed four clinical practice days, then four simulation days, and finally four additional clinical practice days. Group C: Completed eight clinical practice days followed by four simulation days.
| Arm | Type | Receives |
|---|---|---|
| Simulation-First Hybrid Training | Experimental | Other: Educational/trainingStudents in Simulation-First Hybrid Training participated in four days of simulation-based training followed by eight days of clinical practice. Simulation sessions were conducted in subgroups of 4-5 students, followed by debriefing sessions. Clinical practice was conducted in hospital settings under faculty supervision. |
| Clinical Practice-Simulation-Clinical Practice (Integrated Training) | Experimental | Other: Educational/trainingStudents in Clinical Practice-Simulation-Clinical Practice (Integrated Training) first completed four days of clinical practice, then four days of simulation-based training, followed by an additional four days of clinical practice. Simulation and clinical practice sessions were conducted as described for Simulation-First Hybrid Training. |
| Clinical Practice-First Training Followed by Simulation | Experimental | Other: Educational/trainingStudents in Clinical Practice-First Training Followed by Simulation completed eight days of clinical practice, followed by four days of simulation-based training. Simulation and clinical practice sessions were conducted as described for Simulation-First Hybrid Training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergraduate nursing students enrolled in the second year of the program
- Willing to participate in the study
Key exclusion criteria (2 listed)
- Students under 18 years of age
- Students who do not provide voluntary consent
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 |
|---|---|---|
| Educational/trainingSimulation-First Hybrid Training - Simulation → Clinical Practice: Students first participated in four days of simulation in subgroups of 4-5, using low-fidelity mannequins for scenarios such as colorectal surgery care, subdural hematoma, BPH surgery, coronary bypass, femur fracture, and total laryngectomy. Prebriefing and debriefing (GAS method) were conducted. This was followed by eight days of clinical practice under faculty supervision. Clinical Practice-Simulation-Clinical Practice (Integrated Training) - Clinical Practice → Simulation → Clinical Practice: Students completed four days of clinical practice, four days of simulation as above, then four additional clinical practice days. Clinical Practice-First Training Followed by Simulation - Clinical Practice → Simulation: Students completed eight days of clinical practice followed by four days of simulation. Simulation sessions and clinical practice were conducted under faculty supervision. | Other | Clinical Practice-First Training Followed by Simulation, Clinical Practice-Simulation-Clinical Practice (Integrated Training), Simulation-First Hybrid Training |
Primary outcome
Nursing Competence
Time frame: up to 12 weeks
The primary outcome is the level of nursing competence of second-year undergraduate nursing students, measured using a validated Nursing Competence Scale. Competence assessment includes clinical skills, decision-making, and ability to apply theoretical knowledge in simulation and clinical practice settings.
Simulation Learning
Time frame: up to 12 weeks
Learning outcomes specific to simulation sessions were assessed using the Simulation Learning Evaluation Scale. This scale measures students' understanding, performance, and ability to apply skills in the simulated environment. Administered to each laboratory subgroup after simulation.
1 secondary outcome
Demographic Data
Time frame: Baseline (pre-intervention)
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 26 Nov 2025.
- Individual participant dataSharing planned: No. ndividual participant data will not be shared due to privacy and ethical considerations of student participation.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational/training in people with Health Knowledge, Attitudes, Practice, run by Duzce 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 2 inclusion and 2 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 26 Nov 2025. 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?
Nursing Competence (time frame: up to 12 weeks). The study lists 2 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 26 Nov 2025.