Standardized Patient and In Situ Simulation for IV Infiltration Recognition

NCT07514247 | Not Yet Recruiting

• 1 other identifier: TBAEK-77
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Patient Safety; Peripheral Intravenous Catheter-Related İnfiltration

Keywords

in-situ simulation; nursing education; simulation based learning; patient safety; infiltration

Outcome Measures

Primary Outcomes (2)

• 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' (1983) clinical decision-making performance scale. The original Clinical Decision-Making Performance Scale consists of 40 items and four sub-dimensions. A reliability and validity study of clinical decision-making performance in Turkish clinics was conducted by Durmaz and Dicle (2015). 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 Outcomes (2)

• Student Satisfaction and Self-Confidence Scale in Learning

  immediately after the intervention

• Simulation Design Scale

  Immediately after the intervention

Study Arms (3)

Arm 1: Standardized Patient Simulation Group

EXPERIMENTAL

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 (e.g., PEARLS).

Other: Intervention: Standardized Patient Simulation

Arm 2: In Situ Simulation Group

EXPERIMENTAL

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

Arm 3: Control Group (Traditional Education)

NO INTERVENTION

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.

Interventions

Intervention: Standardized Patient Simulation OTHER

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 (e.g., PEARLS).

Arm 1: Standardized Patient Simulation Group

Intervention: In Situ Simulation OTHER

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.

Arm 2: In Situ Simulation Group

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Selçuk Görücü: lead

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Selçuk Görücü, PhD student

CONTACT

5079554505; selcukgorucu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student and Lecturer

Model Details: This study is a randomized controlled trial.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 7, 2026
• Study Start: April 25, 2026
• Primary Completion: May 5, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share