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Patient SafetyNCT07514247

Standardized Patient and In Situ Simulation for IV Infiltration Recognition

A study testing Intervention: Standardized Patient Simulation and Intervention: In Situ Simulation in people with Patient Safety and Peripheral Intravenous Catheter-Related İnfiltration, run by Selçuk Görücü at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Intervention: Standardized Patient Simulation and Intervention: In Situ Simulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Apr 2026to 10 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Aydın Adnan Menderes University

    Aydin

Other trials in Turkey (Türkiye)

About this study

Official title: 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 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.

Read more

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.

Read the detailed description

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.

Being tested
Intervention: Standardized Patient Simulation, Intervention: In Situ Simulation
Keywords
in-situ simulation, nursing education, simulation based learning, patient safety, infiltration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention: Standardized Patient SimulationOther

    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.

  • Intervention: In Situ SimulationOther

    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.

Study groups in NCT07514247
Study groupRoleWhat they receive
Arm 1: Standardized Patient Simulation GroupExperimentalDescription: 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.
Receives: Other: Intervention: Standardized Patient Simulation
Arm 2: In Situ Simulation GroupExperimentalDescription: 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.
Receives: Other: Intervention: In Situ Simulation
Arm 3: Control Group (Traditional Education)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Decision-Making in Nursing Scale (CDMNS) Total Score

    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).

    Measured: Baseline (before the intervention) and immediately after the intervention

  2. Infiltration Knowledge Test Score

    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).

    Measured: Baseline (before the intervention) and immediately after the intervention

Secondary outcomes (2)
  1. Student Satisfaction and Self-Confidence in Learning Scale (SSSCLS) Score

    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).

    Measured: immediately after the intervention

  2. Simulation Design Scale (SDS) Score

    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.

    Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start25 Apr 2026
  3. Primary completion25 May 2026
  4. Study completion10 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a randomized controlled trial.
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07514247
Sponsor's protocol ID
TBAEK-330
Other IDs
TBAEK-77
Status last verified
Oct 2026
First submitted
26 Mar 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. Aggregate data supporting the published findings are available from the principal investigator upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention: Standardized Patient Simulation and Intervention: In Situ Simulation in people with Patient Safety and Peripheral Intravenous Catheter-Related İnfiltration, run by Selçuk Görücü at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Decision-Making in Nursing Scale (CDMNS) Total Score (time frame: Baseline (before the intervention) and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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