Standardized Patient and In Situ Simulation for IV Infiltration Recognition
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-23
SponsorSelçuk Görücü
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Students reviewing the "Fundamentals of Nursing" course
Students who refused to participate in the study
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention: Standardized Patient Simulation
Other interventionDescription: 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.
Intervention: In Situ Simulation
Other interventionDescription: 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Arm 1: Standardized Patient Simulation GroupExperimental treatment 1 intervention
Group B: Arm 2: In Situ Simulation GroupExperimental treatment 1 intervention
Group C: Arm 3: Control Group (Traditional Education)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-intervention and immediately after the intervention2
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.
Time frame
Pre-intervention and immediately after the interventionSecondary outcomes
1
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.
Time frame
immediately after the intervention2
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.
Time frame
Immediately after the interventionLocations
Sponsors and contacts
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Selçuk Görücü
Lead sponsor
Aydin Adnan Menderes University
Sponsor institution
Source ClinicalTrials.gov
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