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临床试验/NCT07514247
NCT07514247尚未招募不适用

Effects Of Standardized Patient and In Situ Simulation On Nursing Students' Peripheral Intravenous Catheter-Related Infiltration Recognition and Clinical Decision-Making: A Randomized Controlled Trial

Selçuk Görücü0 个研究点目标入组 90 人开始时间: 2026年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
主要终点
Infiltration Knowledge Test

研究概览

简要总结

Peripheral intravenous catheters (PIVCs) are widely used invasive devices in hospital settings and are associated with a broad range of complications, among which infiltration is one of the most common and clinically significant. Infiltration, defined as the leakage of intravenous fluids or medications into surrounding tissues, may result in local tissue damage, pain, infection, delayed treatment, and increased healthcare costs. Despite its high prevalence and impact on patient safety, early recognition and appropriate management of infiltration remain challenging, particularly among nursing students.

Conventional educational approaches that rely predominantly on theoretical instruction may be insufficient to develop the clinical reasoning and decision-making skills required for timely identification and management of such complications. Therefore, there is a growing emphasis on the use of innovative, learner-centered educational strategies that promote active participation and experiential learning.

Simulation-based education, including in situ simulation and standardized patient methodologies, has been shown to provide realistic, safe, and effective learning environments that enhance both technical and non-technical skills. In situ simulation enables training within real clinical settings using existing resources and team structures, while standardized patients facilitate the development of communication, clinical assessment, and decision-making competencies.

This randomized controlled trial aims to evaluate the effectiveness of standardized patient and in situ simulation-based training, compared with traditional teaching methods, in improving nursing students' ability to recognize PIVC-related infiltration and enhance their clinical decision-making skills. Secondary outcomes include learning satisfaction and self-confidence.

By integrating evidence-based simulation approaches into nursing education, this study seeks to strengthen clinical competence and contribute to improved patient safety outcomes.

详细描述

Peripheral intravenous catheters (PIVCs) are among the most commonly used invasive devices for delivering intravenous therapy in hospital settings. PIVC insertion is one of the most frequently performed invasive procedures under the responsibility of nurses and is associated with a wide range of complications. These complications include phlebitis, infiltration, extravasation, pain, local infection, ecchymosis, hematoma, thrombophlebitis, embolism, and pulmonary edema.

Among these, infiltration is one of the most prevalent complications and is characterized by the leakage of intravenous fluids or medications into surrounding tissues. This condition may result in local tissue damage, pain, infection, delayed treatment, and increased healthcare costs. The incidence of infiltration has been reported to range between 13% and 20%, representing a substantial burden on both patient outcomes and healthcare systems. Furthermore, PIVC-related complications are considered to be more extensive than currently reported, with estimates suggesting that up to 70-90% of patients with PIVCs may experience complications that can prolong hospital stays by up to 22 days. These complications negatively affect patient comfort, contribute to unnecessary diagnostic and therapeutic interventions, delay treatment processes, increase healthcare costs, elevate patient stress levels, and intensify the workload of healthcare professionals.

In this context, early recognition of infiltration and the development of clinical decision-making skills among nursing students are critical for ensuring patient safety. Traditional educational approaches that primarily focus on theoretical knowledge are increasingly being recognized as insufficient for preparing students to manage complex clinical situations. Consequently, there is a growing need for realistic, interactive, and learner-centered educational strategies that support early identification of complications and appropriate clinical decision-making.

Simulation-based education has emerged as an effective approach for improving patient safety-related outcomes. One cost-effective and contextually relevant form of simulation is in situ simulation, which is conducted in real clinical environments such as hospital units or other healthcare settings. In situ simulation is a team-based training method that utilizes existing equipment and involves actual healthcare team members, thereby enhancing realism and system-level awareness. Beyond improving individual technical and non-technical skills, such as communication and teamwork, in situ simulation also enables the identification of latent system vulnerabilities that may contribute to medical errors.

Simulation-based learning provides a safe environment that minimizes patient harm while facilitating the development of clinical competencies. In addition, standardized patients-trained individuals who accurately simulate real patient scenarios-are widely used for educational, assessment, and research purpos. This method has been shown to enhance students' communication skills, practical competencies, professional attitudes (including empathy), and clinical decision-making abilities, ultimately contributing to improved patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 23 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • First-year undergraduate nursing students at the Faculty of Nursing
  • Students enrolling in the "Fundamentals of Nursing" course for the first time
  • Students who gave informed consent and agreed to participate in the study voluntarily.

排除标准

  • Students reviewing the "Fundamentals of Nursing" course
  • Students who refused to participate in the study

研究组 & 干预措施

Arm 1: Standardized Patient Simulation Group

Experimental

Description:

Participants receive training through standardized patient-based simulation scenarios specifically designed to represent early and progressive signs of PIVC-related infiltration. Students perform patient assessment, clinical reasoning, and decision-making tasks in a controlled environment. Each session includes structured debriefing using an evidence-based model.

干预措施: Intervention: Standardized Patient Simulation (Other)

Arm 2: In Situ Simulation Group

Experimental

Description:

Participants engage in simulation conducted in real clinical settings using existing hospital equipment and workflows. Scenarios focus on the recognition and management of infiltration within authentic clinical contexts. The intervention emphasizes situational awareness, teamwork, and system-based factors. Structured debriefing is conducted following each session.

干预措施: Intervention: In Situ Simulation (Other)

Arm 3: Control Group (Traditional Education)

No Intervention

Arm 3: Control Group (Traditional Education) Intervention: Traditional Teaching

Description:

Participants receive conventional education consisting of theoretical instruction (e.g., lectures and/or standard skills demonstrations) related to PIVC complications, including infiltration, without exposure to simulation-based training.

结局指标

主要结局

Infiltration Knowledge Test

时间窗: Pre-intervention and immediately after the intervention

The "Infiltration Knowledge Test" will be administered to students in both the experimental and control groups before the intervention and after skill performance assessments. The knowledge test consists of 10 multiple-choice questions prepared by the researcher based on the literature. Scores on the test range from 0 to 100. Scores closer to 100 can be interpreted as an increase in students' knowledge of infiltration.

Clinical Decision-Making Skills

时间窗: Pre-intervention and immediately after the intervention

Clinical decision-making perception has been assessed using Jenkins clinical decision-making performance scale. The original Clinical Decision-Making Performance Scale consists of 40 items and four sub-dimensions. The subscales are, respectively: "Exploring options and comprehensively", "Investigating goals and values", "Evaluating outcomes", and "Researching information and following up as new records". The total score of the scale is between 40 and 200, and the sub-dimension score is between 10 and 50; there is no cutoff point. A high score indicates a high perception of decision-making, while a low score indicates a low perception of decision-making. The scale is evaluated based on its subscale and total scale score.

次要结局

  • Student Satisfaction and Self-Confidence Scale in Learning(immediately after the intervention)
  • Simulation Design Scale(Immediately after the intervention)

研究者

发起方
Selçuk Görücü
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Selçuk Görücü

PhD Student and Lecturer

Aydin Adnan Menderes University

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