이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

표준화 환자와 현장 시뮬레이션을 통한 정맥 주사 침윤 인식

2026년 10월 28일 업데이트: Selçuk Görücü

표준화 환자 및 현장 시뮬레이션이 간호학생의 말초정맥 카테터 관련 침윤 인식과 임상적 의사결정에 미치는 영향: 무작위 대조 시험

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

64

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

실험적: 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.

간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Clinical Decision-Making in Nursing Scale (CDMNS) Total Score
기간: Baseline (before the intervention) and immediately after the intervention

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
Infiltration Knowledge Test Score
기간: Baseline (before the intervention) and immediately after the intervention

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

2차 결과 측정

결과 측정
측정값 설명
기간
Student Satisfaction and Self-Confidence in Learning Scale (SSSCLS) Score
기간: immediately after the intervention

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
Simulation Design Scale (SDS) Score
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Selçuk Görücü, PhD, Aydin Adnan Menderes University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 25일

기본 완료 (실제)

2026년 5월 25일

연구 완료 (실제)

2026년 6월 10일

연구 등록 날짜

최초 제출

2026년 3월 26일

QC 기준을 충족하는 최초 제출

2026년 3월 30일

처음 게시됨 (실제)

2026년 4월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 28일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TBAEK-330
  • TBAEK-77 (기타 식별자: Akdeniz University Faculty of Medicine Clinical Research Ethics Committee)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared. Aggregate data supporting the published findings are available from the principal investigator upon reasonable request.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .