NCT07512986

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Apr 2026May 2026

First Submitted

Initial submission to the registry

March 27, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 6, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

April 12, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2026

Expected
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

18 days

First QC Date

March 27, 2026

Last Update Submit

May 3, 2026

Conditions

Keywords

nursing educationPIVC-related phlebitisvideo-based learningpatient safetysimulation based learning

Outcome Measures

Primary Outcomes (2)

  • Phlebitis Recognition Knowledge

    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

    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 Outcomes (2)

  • Student Satisfaction and Self-Confidence Scale in Learning

    Immediately post-intervention

  • Simulation Design Scale

    Immediately post-intervention

Study Arms (3)

Arm 1: Standardized Patient Simulation Group

EXPERIMENTAL

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.

Behavioral: Standardized Patient Simulation

Arm 2: Video-Based Learning Group

EXPERIMENTAL

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.

Device: Video-Based Training

Control Group (Traditional Education)

NO INTERVENTION

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.

Interventions

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.

Arm 1: Standardized Patient Simulation Group

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.

Arm 2: Video-Based Learning Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Students reviewing the "Fundamentals of Nursing" course
  • Students who do not wish to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesVasculitis

Central Study Contacts

Selçuk Görücü, PhD Student

CONTACT

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

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 6, 2026

Study Start

April 12, 2026

Primary Completion

April 30, 2026

Study Completion (Estimated)

May 12, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share