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临床试验/NCT07512986
NCT07512986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12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
Phlebitis Recognition Knowledge

研究概览

简要总结

Peripheral intravenous catheters (PIVCs) are widely used for vascular access and represent one of the most common invasive procedures in hospitalized patients. Despite their clinical utility, PIVCs are associated with various complications, among which phlebitis is one of the most frequent and clinically significant. Phlebitis, characterized by inflammation of the venous wall, may occur during catheterization or within 24-96 hours after catheter removal and is associated with symptoms such as pain, erythema, swelling, and increased local temperature. Reported incidence rates vary widely in the literature, ranging from 1.5% to 80%, indicating a substantial burden on patient safety and healthcare systems.

PIVC-related complications contribute to prolonged hospital stays, increased healthcare costs, delayed treatment, and reduced patient comfort, while also increasing the workload of healthcare professionals. In this context, early recognition of phlebitis and effective clinical decision-making are critical competencies for nursing students. However, traditional teaching approaches that primarily focus on theoretical knowledge may be insufficient to develop these complex clinical skills.

Innovative, learner-centered educational strategies, such as video-based learning and simulation-based education, offer dynamic and interactive learning environments that promote active engagement and experiential learning. Video-based learning enhances accessibility, flexibility, and student engagement, while simulation-based approaches-particularly those involving standardized patients-provide realistic, safe environments for developing clinical, communication, and decision-making skills.

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

By integrating evidence-based educational strategies, this study seeks to advance nursing education and contribute to improved patient safety by fostering clinically competent and confident future nurses.

详细描述

Peripheral intravenous catheter (PIVC) cannulation is a widely used method for vascular access and is considered one of the most common invasive procedures performed in hospitalized patients. This technique provides rapid access to the vascular system due to being less invasive and less complex compared to alternative methods. The type of catheter is selected based on the estimated duration and type of therapy, and PIVCs are commonly used for fluid therapy, parenteral nutrition, administration of blood products, and diagnostic procedures.

Phlebitis, one of the most common complications associated with PIVCs, may develop not only during catheterization but also within 24-96 hours after catheter removal. The incidence of PIVC-related phlebitis varies widely in the literature, ranging from 1.5% to 80%. Phlebitis is defined as acute inflammation of the venous wall resulting from irritation of the vascular endothelium at or near the catheter insertion site. Its identification requires the assessment of clinical signs and symptoms at the insertion site, including erythema, swelling along the vein, pain, warmth, and, in some cases, fever.

It is estimated that complications related to PIVCs are more extensive than currently reported, with approximately 70-90% of patients experiencing complications that may prolong hospital stays by up to 22 days. These complications negatively affect patient comfort, contribute to unnecessary diagnostic and therapeutic interventions, delay treatment, increase healthcare costs, elevate patient stress, and increase the workload of healthcare professionals.

In this context, early recognition of phlebitis and the development of clinical decision-making skills among nursing students are critical for ensuring patient safety. Traditional educational approaches that focus primarily on the transfer of theoretical knowledge are increasingly insufficient for preparing students to manage complex clinical situations. Therefore, there is a growing need for realistic, interactive, and learner-centered educational strategies that support early diagnosis and appropriate clinical decision-making. Innovative teaching methods that promote active student engagement and provide opportunities to experience clinical situations in a safe environment play a strategic role in developing these essential competencies.

One such innovative approach is video-based learning, which has emerged as a powerful educational tool by providing a dynamic and engaging platform for content delivery. Video-based learning refers to the acquisition of knowledge and skills through video materials and encompasses various strategies designed to enhance student engagement and learning outcomes, particularly in fields such as healthcare education where practical skills are essential. In addition to being learner-centered, video-based learning offers advantages such as increased engagement, accessibility, and flexibility. These benefits highlight the need for more comprehensive and experiential learning environments in which learners move beyond passive observation to actively interpret clinical contexts and mentally rehearse decision-making processes.

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 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being a first-year student in the Faculty of Nursing
  • Being enrolled in the "Fundamentals of Nursing" course for the first time
  • Being a volunteer to participate in the study

排除标准

  • Students reviewing the "Fundamentals of Nursing" course
  • Students who do not wish to participate in the research

研究组 & 干预措施

Arm 1: Standardized Patient Simulation Group

Experimental

Description:

Participants in this arm receive training through standardized patient (SP)-based simulation scenarios designed to reflect clinical signs and symptoms of peripheral intravenous catheter (PIVC)-related phlebitis. Trained standardized patients portray consistent case scenarios, enabling students to perform patient assessment, identify early signs of phlebitis (e.g., erythema, pain, swelling, and warmth), and engage in clinical decision-making. The intervention emphasizes the integration of cognitive, psychomotor, and affective skills, including communication and empathy. Each session is followed by a structured debriefing process using an evidence-based model (e.g., PEARLS) to support reflective learning and clinical reasoning.

干预措施: Standardized Patient Simulation (Behavioral)

Control Group (Traditional Education)

No Intervention

Participants in the control group receive conventional classroom-based theoretical instruction on PIVC-related complications, including phlebitis. The teaching method consists of lectures and/or standard instructional materials without the use of simulation or video-based learning components. This arm represents the standard educational approach for comparison with innovative, learner-centered interventions.

Arm 2: Video-Based Learning Group

Experimental

Participants in this arm receive video-based educational content specifically developed to demonstrate the recognition and management of PIVC-related phlebitis. The videos include standardized clinical scenarios presenting visual and contextual cues such as insertion site changes, patient-reported symptoms, and appropriate nursing interventions. This intervention allows students to repeatedly observe clinical situations, facilitating cognitive rehearsal and reinforcing clinical reasoning processes. The video-based learning approach is structured to promote active engagement, improve knowledge retention, and support flexible, self-paced learning.

干预措施: Video-Based Training (Device)

结局指标

主要结局

Phlebitis Recognition Knowledge

时间窗: Baseline (pre-intervention) and immediately post-intervention

The level of knowledge regarding the recognition of peripheral intravenous catheter (PIVC)-related phlebitis, including identification of signs and symptoms such as erythema, swelling, pain, and warmth. Measurement Tool: The "Phlebitis Assessment Knowledge Test" was administered to students in both the experimental and control groups before the intervention and after skill performance assessments. The knowledge test consisted of 10 multiple-choice questions prepared by the researcher based on the literature. Expert opinions on the test will be obtained from five faculty members specializing in the Fundamentals of Nursing. The test is scored between 0 and 100. Higher scores indicate a higher level of knowledge in diagnosing and evaluating phlebitis.

Clinical Decision-Making Skills

时间窗: Baseline (pre-intervention) and immediately post-intervention

This scale describes how nursing students perceive clinical decision-making based on their own statements (Jenkins, 2001). The original Clinical Decision-Making Scale for Nursing (CDM) consists of 40 items and four subscales. A reliability and validity study of the CDM in nursing in Turkey was conducted by Durmaz and Dicle (2015). The subscales are, respectively: "Exploring options and ideas", "Investigating goals and values", "Evaluating outcomes", and "Exploring information and adopting new information impartially". Each subscale consists of 10 items. Scores range from 40 to 200 for the total scale and from 10 to 50 for each subscale; 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 each subscale and the total scale score.

次要结局

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

Aydin Adnan Menderes University

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