Standardized Patient and In Situ Simulation for IV Infiltration Recognition

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Safety; Peripheral Intravenous Catheter-Related İnfiltration
• Intervention / Treatment: Other: Intervention: In Situ Simulation; Other: Intervention: Standardized Patient Simulation

Detailed Description

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.

This study is grounded in the recognition that infiltration, although common, is often detected late in clinical practice and cannot be effectively addressed through theoretical instruction alone. Given its direct impact on patient safety, the inability of nursing students to adequately recognize and manage this complication highlights the need for a strategic transformation in educational approaches.

Accordingly, this study aims to evaluate the effectiveness of innovative, learner-centered educational models-specifically standardized patient and in situ simulation-compared to traditional teaching methods, in enhancing nursing students' ability to recognize infiltration and improve their clinical decision-making skills. By doing so, the study seeks to contribute to the advancement of nursing education and support the development of competent, safety-oriented future nurses.

Research Hypotheses H1: Nursing students who receive training through standardized patient or in situ simulation methods will demonstrate higher levels of knowledge in recognizing infiltration compared to those receiving traditional education.

H2: Nursing students who receive training through standardized patient or in situ simulation methods will achieve higher clinical decision-making scores compared to those receiving traditional education.

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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Selçuk Görücü, PhD Student; Phone Number: 5079554505; Email: selcukgorucu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 2: In Situ Simulation Group; 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.	Other: Intervention: In Situ Simulation; 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.
No Intervention: Arm 3: Control Group (Traditional Education); 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.
Experimental: Arm 1: Standardized Patient Simulation Group; 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.	Other: Intervention: Standardized Patient Simulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infiltration Knowledge Test	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.	Pre-intervention and immediately after the intervention
Clinical Decision-Making Skills	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.	Pre-intervention and immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Student Satisfaction and Self-Confidence Scale in Learning	This scale measures students' satisfaction and self-confidence in learning in a simulation environment. The scale is a five-point Likert type, with response options for items expressing student feelings: 1) Strongly disagree, 2) Disagree, 3) Undecided, 4) Agree, and 5) Strongly agree; there are no negative items. The Cronbach's alpha value was found to be 0.85 for "Satisfaction with Current Learning" and 0.77 for "Self-Confidence in Learning". An increase in the score obtained from the scale indicates increased student satisfaction and self-confidence in learning.	immediately after the intervention
Simulation Design Scale	The scale consists of 5 subscales and 20 items: "Goals and Knowledge", "Support", "Problem Solving", "Feedback/Guided Reflection", and "Accuracy". Developed by Jeffries and Rizzolo, the scale was adapted into Turkish by Unver. The scale can be scored from a minimum of 1 to a maximum of 5. A high total score indicates that the best simulation design elements have been applied in the simulation application. The second part of the scale measures how important the simulation application is to the students. A high total score indicates that the student attaches high importance to the simulation experience. Cronbach's alpha values for the subscales range from 0.73 to 0.86.	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Selçuk Görücü

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2026
• Primary Completion (Estimated): May 5, 2026
• Study Completion (Estimated): May 25, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: patient safety; infiltration; nursing education; in-situ simulation; simulation based learning
• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: TBAEK-77

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No