Viewing Study NCT07250451


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Study NCT ID: NCT07250451
Status: COMPLETED
Last Update Posted: 2025-11-26
First Post: 2025-11-18
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Simulation Education and Clinical Practice on Nursing Students' Competence
Sponsor: Duzce University
Organization:

Study Overview

Official Title: The Effect Of Multiple Scenarios Simulation Education And Clinical Practice On Nursing Students' Competence: Quasi Experimental Crossover Study
Status: COMPLETED
Status Verified Date: 2025-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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. 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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: