Standardisierter Patient und In-Situ-Simulation zur Erkennung von IV-Infiltrationen
Auswirkungen standardisierter Patienten und In-Situ-Simulation auf die Erkennung von peripheren intravenösen Katheter-assoziierten Infiltrationen und die klinische Entscheidungsfindung bei Pflegestudenten: Eine randomisierte kontrollierte Studie
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.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
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 purposes. 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.
Protocol amendment: Under the originally approved protocol (ethics approval TBAEK-77), the second intervention group was to receive video-based training. Before any participant was enrolled, the protocol was amended (ethics approval TBAEK-330, approved March 26, 2026) to replace the video-based training group with an in situ simulation group. The study was conducted entirely in accordance with the amended protocol.
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Aydin, Türkei (türkiye)
- Aydın Adnan Menderes University
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Experimental: Arm 1: Standardized Patient Simulation Group
Description: In addition to the standard theoretical course on PIVC-related complications received by all groups, 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. |
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. |
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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. |
Description: In addition to the standard theoretical course on PIVC-related complications received by all groups, 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. |
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Kein Eingriff: Arm 3: Control Group (Traditional Education)
Participants receive only the standard theoretical course on PIVC-related complications, including infiltration, which is common to all groups. They do not receive simulation-based training. |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Clinical Decision-Making in Nursing Scale (CDMNS) Total Score
Zeitfenster: Baseline (before the intervention) and immediately after the intervention
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Clinical decision-making perception was assessed using the Turkish version of the Clinical Decision-Making in Nursing Scale. The scale consists of 40 items rated on a 5-point Likert scale across four subscales of 10 items each: exploring options comprehensively, investigating goals and values, evaluating outcomes, and searching for information and following up. Subscale scores are the sum of their items (range 10-50), and the total score is the sum of all items (range 40-200). There is no cut-off point. Higher scores indicate a higher perception of clinical decision-making (better outcome). |
Baseline (before the intervention) and immediately after the intervention
|
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Infiltration Knowledge Test Score
Zeitfenster: Baseline (before the intervention) and immediately after the intervention
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Knowledge of PIVC-related infiltration was assessed using a researcher-developed knowledge test consisting of 10 multiple-choice questions based on the literature, each worth 10 points. Total scores range from 0 to 100; higher scores indicate greater knowledge of infiltration (better outcome). |
Baseline (before the intervention) and immediately after the intervention
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Student Satisfaction and Self-Confidence in Learning Scale (SSSCLS) Score
Zeitfenster: immediately after the intervention
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Satisfaction and self-confidence in learning were assessed using the Turkish version of the Student Satisfaction and Self-Confidence in Learning Scale (12 items; satisfaction with current learning, 5 items; self-confidence in learning, 7 items), rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree), with no reverse-scored items. Scores range from 1 to 5; higher scores indicate greater satisfaction and self-confidence (better outcome). |
immediately after the intervention
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Simulation Design Scale (SDS) Score
Zeitfenster: Immediately after the intervention
|
The Simulation Design Scale, consists of 20 items across five subscales: objectives and information, support, problem solving, feedback/guided reflection, and fidelity. Each item is rated from 1 to 5. Higher scores indicate that the simulation design elements were present to a greater extent (better outcome). The second part of the scale, rated on the same 1-5 range, measures the importance students attribute to each design element; higher scores indicate greater perceived importance. |
Immediately after the intervention
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Selçuk Görücü, PhD, Aydin Adnan Menderes University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- TBAEK-330
- TBAEK-77 (Andere Kennung: Akdeniz University Faculty of Medicine Clinical Research Ethics Committee)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Individual participant data will not be shared. Aggregate data supporting the published findings are available from the principal investigator upon reasonable request.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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