- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250451
Simulation Education and Clinical Practice on Nursing Students' Competence
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Düzce, Turkey (Türkiye), 81000
- Duzce University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergraduate nursing students enrolled in the second year of the program
- Willing to participate in the study
Exclusion Criteria:
- Students under 18 years of age
- Students who do not provide voluntary consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Simulation-First Hybrid Training
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.
|
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. |
|
Experimental: Clinical Practice-Simulation-Clinical Practice (Integrated Training)
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.
|
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. |
|
Experimental: Clinical Practice-First Training Followed by Simulation
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 12 weeks
|
|
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.
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic Data
Time Frame: Baseline (pre-intervention)
|
Demographic information including age, gender, and academic background was collected from all participants using a structured demographic form before clinical practice.
|
Baseline (pre-intervention)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DU-AE-01
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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