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Not yet recruiting NCT07512986

Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students

No phase Interventional Phlebitis Clinical Decision-Making in Nursing Learning Satisfaction and Self-confidence Standardized Patient

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standardized Patient Simulation, Video-Based Training.
Who it may be relevant to
Registry conditions: Phlebitis, Clinical Decision-Making in Nursing, Learning Satisfaction and Self-confidence, Standardized Patient. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Another innovative teaching approach is simulation-based learning, which utilizes a range of methods-including low- and high-fidelity mannequins, virtual reality, standardized patients, and hybrid applications-to create realistic and effective learning experiences. Simulation-based education provides a safe learning environment that minimizes patient harm while facilitating the development of clinical skills. Standardized patients are trained individuals who accurately simulate real patient scenarios for educational, assessment, and research purposes. This method enhances students' communication skills, practical competencies, professional attitudes (including empathy), and clinical decision-making abilities, thereby contributing to improved patient outcomes.

This study is grounded in the recognition that phlebitis, although common, is often identified late in clinical practice and cannot be effectively addressed through theoretical instruction alone. The inability of nursing students to adequately recognize and manage this complication, which directly impacts patient safety, necessitates a strategic reconsideration of current educational approaches. Accordingly, this study aims to evaluate the effectiveness of innovative, learner-centered educational models-specifically standardized patient and video-based training-compared with traditional teaching methods in enhancing nursing students' ability to recognize phlebitis and improve their clinical decision-making skills. Ultimately, this study seeks to contribute to the advancement of nursing education and support the development of competent, safety-oriented nursing professionals.

Research Hypotheses H1: Nursing students who receive training through standardized patient or video-based learning methods will demonstrate higher levels of knowledge in recognizing phlebitis compared to those receiving traditional education.

H2: Nursing students who receive training through standardized patient or video-based learning methods will achieve higher clinical decision-making skill scores compared to those receiving traditional education.

H3: Nursing students who receive training through standardized patient or video-based learning methods will report higher levels of learning satisfaction and self-confidence compared to those receiving traditional education.

Interventions

  • Behavioral Standardized Patient Simulation
    This intervention consists of structured, scenario-based training using standardized patients who are trained to consistently portray clinical manifestations of peripheral intravenous catheter (PIVC)-related phlebitis. Participants are required to perform patient assessment, identify clinical signs (e.g., erythema, pain, swelling, warmth), and make appropriate clinical decisions regarding management. The simulation is conducted in a controlled environment and integrates cognitive, psychomotor, a
  • Device Video-Based Training
    This intervention includes structured video-based educational materials developed to demonstrate the recognition and management of PIVC-related phlebitis. The videos present standardized clinical scenarios with visual and auditory cues, including patient symptoms and appropriate nursing interventions. Participants engage with the content in a guided format, allowing for repeated viewing and cognitive rehearsal. The intervention is designed to enhance knowledge acquisition, clinical reasoning, an

Primary outcome measures

  • Phlebitis Recognition Knowledge [Time frame: Baseline (pre-intervention) and immediately post-intervention]
  • Clinical Decision-Making Skills [Time frame: Baseline (pre-intervention) and immediately post-intervention]
Secondary outcome measures (2)
  • Student Satisfaction and Self-Confidence Scale in Learning [Time frame: Immediately post-intervention]
  • Simulation Design Scale [Time frame: Immediately post-intervention]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07512986 · TBAEK-76

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗