- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512986
Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students
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 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
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
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: Standardized Patient Simulation Group
Description: Participants in this arm receive training through standardized patient (SP)-based simulation scenarios designed to reflect clinical signs and symptoms of peripheral intravenous catheter (PIVC)-related phlebitis. Trained standardized patients portray consistent case scenarios, enabling students to perform patient assessment, identify early signs of phlebitis (e.g., erythema, pain, swelling, and warmth), and engage in clinical decision-making. The intervention emphasizes the integration of cognitive, psychomotor, and affective skills, including communication and empathy. Each session is followed by a structured debriefing process using an evidence-based model (e.g., PEARLS) to support reflective learning and clinical reasoning. |
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, and affective learning domains.
Each session is followed by a structured debriefing (e.g., PEARLS model) to enhance reflective learning and clinical reasoning.
|
|
Experimental: Arm 2: Video-Based Learning Group
Participants in this arm receive video-based educational content specifically developed to demonstrate the recognition and management of PIVC-related phlebitis.
The videos include standardized clinical scenarios presenting visual and contextual cues such as insertion site changes, patient-reported symptoms, and appropriate nursing interventions.
This intervention allows students to repeatedly observe clinical situations, facilitating cognitive rehearsal and reinforcing clinical reasoning processes.
The video-based learning approach is structured to promote active engagement, improve knowledge retention, and support flexible, self-paced learning.
|
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, and learner engagement through flexible and accessible learning.
|
|
No Intervention: Control Group (Traditional Education)
Participants in the control group receive conventional classroom-based theoretical instruction on PIVC-related complications, including phlebitis.
The teaching method consists of lectures and/or standard instructional materials without the use of simulation or video-based learning components.
This arm represents the standard educational approach for comparison with innovative, learner-centered interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phlebitis Recognition Knowledge
Time Frame: Baseline (pre-intervention) and immediately post-intervention
|
The level of knowledge regarding the recognition of peripheral intravenous catheter (PIVC)-related phlebitis, including identification of signs and symptoms such as erythema, swelling, pain, and warmth. Measurement Tool: The "Phlebitis Assessment Knowledge Test" was administered to students in both the experimental and control groups before the intervention and after skill performance assessments. The knowledge test consisted of 10 multiple-choice questions prepared by the researcher based on the literature. Expert opinions on the test will be obtained from five faculty members specializing in the Fundamentals of Nursing. The test is scored between 0 and 100. Higher scores indicate a higher level of knowledge in diagnosing and evaluating phlebitis. |
Baseline (pre-intervention) and immediately post-intervention
|
|
Clinical Decision-Making Skills
Time Frame: Baseline (pre-intervention) and immediately post-intervention
|
This scale describes how nursing students perceive clinical decision-making based on their own statements (Jenkins, 2001).
The original Clinical Decision-Making Scale for Nursing (CDM) consists of 40 items and four subscales.
A reliability and validity study of the CDM in nursing in Turkey was conducted by Durmaz and Dicle (2015).
The subscales are, respectively: "Exploring options and ideas", "Investigating goals and values", "Evaluating outcomes", and "Exploring information and adopting new information impartially".
Each subscale consists of 10 items.
Scores range from 40 to 200 for the total scale and from 10 to 50 for each subscale; 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 each subscale and the total scale score.
|
Baseline (pre-intervention) and immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student Satisfaction and Self-Confidence Scale in Learning
Time Frame: Immediately post-intervention
|
The scale, originally developed by Jeffries and Rizzolo (2006) with 13 items, was adapted into Turkish by Unver et al. (2017) with a total of 12 items (Jeffries & Rizzolo, 2006; Unver et al., 2017).
This scale measures students' satisfaction and self-confidence in learning in a simulation environment.
The scale consists of two sub-sections: "Satisfaction with Current Learning" and "Self-Confidence in Learning".
The "Satisfaction with Current Learning" sub-section consists of 5 items, and the "Self-Confidence in Learning" sub-section consists of 7 items.
The scale is a five-point Likert type, with response options for items expressing student feelings being: 1) Strongly disagree, 2) Disagree, 3) Undecided, 4) Agree, and 5) Strongly agree; there are no negative items.
An increase in the score on the scale indicates increased student satisfaction and self-confidence in learning (Unver et al., 2017).
|
Immediately post-intervention
|
|
Simulation Design Scale
Time Frame: Immediately post-intervention
|
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 (2006), the scale was adapted into Turkish by Unver et al. (2017) (Jeffries & Rizzolo, 2006; Unver et al., 2017).
The scale is scored by dividing the total score given to the answers by the number of items.
The lowest possible score on the scale is 1, and the highest is 5.
The first section measures whether the best simulation design elements were applied in the simulation application.
A high total score on the scale indicates that the best simulation design elements were applied in the simulation application.
The second section of the scale measures how important the simulation application is to the students.
A high total score on the scale indicates that the student attaches high importance to the simulation experience they have had (Unver et al., 2017).
|
Immediately post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBAEK-76
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Phlebitis
-
Cukurova UniversityCompleted
-
Corewell Health EastRecruitingPeripheral Intravenous Vein Catheter Phlebitis | Intravenous InfectionUnited States
-
William Beaumont HospitalsWithdrawnPeripheral Intravenous Vein Catheter Phlebitis | Intravenous InfectionUnited States
-
University of Health Sciences LahoreNot yet recruitingPatient With IV Cannula Induce Phlebitis
-
Assistance Publique - Hôpitaux de ParisCompletedVein Infusion PhlebitisFrance
-
University of BasrahUniversity of BaghdadNot yet recruitingCancer | Chemotherapy
-
Kahramanmaras Sutcu Imam UniversityCompleted
-
Royal Brisbane and Women's HospitalUnknown
-
Federal University of São PauloCompleted
Clinical Trials on Standardized Patient Simulation
-
University of Massachusetts, BostonCompletedNurse's Role | Simulation of Physical IllnessUnited States
-
Ankara Yildirim Beyazıt UniversityCompleted
-
Tokat Gaziosmanpasa UniversityCompleted
-
Aybike CiciKafkas UniversityRecruitingColostomy StomaTurkey (Türkiye)
-
Yuksek Ihtisas UniversitySaglik Bilimleri UniversitesiCompletedAnxiety | Self Efficacy | Patient Simulation | Pediatric Nursing | High Fidelity Simulation TrainingTurkey
-
ESRA ERTUĞRULNot yet recruitingFall | Patient Safety | Simulation EdicationTurkey (Türkiye)
-
ESRA ERTUĞRULNot yet recruitingFall | Patient Safety | Simulation EdicationTurkey (Türkiye)
-
Selçuk GörücüNot yet recruitingPatient SafetyTurkey (Türkiye)
-
Selçuk GörücüNot yet recruitingPatient Safety | Peripheral Intravenous Catheter-Related İnfiltration
-
Burdur Mehmet Akif Ersoy UniversityNot yet recruitingNursing EducationTurkey (Türkiye)