- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07637136
Effects of Simulation Fidelity on Patient-Centered Care Competency, Empathy, and Learning Outcomes in Nursing Students: A Randomized Controlled Trial
The Effect of Perceived Patient Fidelity on Patient-Centered Care Competency, Empathy, Learning Self-Confidence, and Satisfaction in Simulation-Based Nursing Education: A Randomized Controlled Trial
연구 개요
상태
상세 설명
Simulation-based education is widely used in nursing training to develop clinical competency in safe environments. The fidelity of simulation particularly whether a standardized patient or a manikin is used may influence the realism of the experience and subsequently affect learning outcomes. However, evidence comparing these two modalities on patient-centered care competency, empathy, and learning outcomes remains limited.
This study will be conducted at Atılım University School of Health Sciences Nursing Skills Laboratory in Ankara, Turkey. Second, third, and fourth-year nursing students who have completed the Internal Medicine Nursing course.
Eligible participants will be randomly assigned. The Standardized Patient Group (experimental) will practice a myocardial infarction nursing care scenario with a trained actor portraying the patient. The Manikin Group (active comparator) will perform the same scenario using a high-fidelity manikin. Both groups will follow an identical structured simulation protocol consisting of three phases: education and briefing (45 minutes), simulation (10-15 minutes), and debriefing (20 minutes).
A semi-structured perceived reality interview will be conducted with the standardized patient group following the simulation. Data will be collected using four instruments: the Patient-Centered Care Competency Scale, the Jefferson Empathy Scale, the Student Satisfaction and Self-Confidence in Learning Scale, and a Descriptive Information Form. All instruments will be administered immediately after the simulation session.
Each group will have at least 20 participants. Data will be analyzed using independent samples t-test or Mann-Whitney U test depending on normality of distribution.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ankara, 터키 (Türkiye), 06830
- Atilim University, Faculty of Health Sciences, Nursing Skills Laboratory
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Second, third, and fourth year undergraduate nursing students at Atılım University School of Health Sciences
- Successfully completed the Internal Medicine Nursing course
- Willingness to participate voluntarily and providing written informed consent
Exclusion Criteria:
- Did not complete the informed consent form
- Withdrawal of consent at any point during the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Standardized Patient Group
Participants in this group will perform a myocardial infarction nursing care scenario with a trained actor portraying the patient in a standardized patient simulation.
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A structured simulation protocol consisting of education and briefing (45 min), simulation (10-15 min), and debriefing (20 min) phases applied to both groups.
The standardized patient group uses a trained actor; the manikin group uses a high-fidelity manikin in an identical myocardial infarction scenario.
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활성 비교기: Manikin Group
Participants in this group will perform the same myocardial infarction nursing care scenario using a high-fidelity manikin simulation.
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A structured simulation protocol consisting of education and briefing (45 min), simulation (10-15 min), and debriefing (20 min) phases applied to both groups.
The standardized patient group uses a trained actor; the manikin group uses a high-fidelity manikin in an identical myocardial infarction scenario.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient-Centered Care Competency Scale Score
기간: Immediately after the simulation session
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Total score obtained from the Patient-Centered Care Competency Scale measuring nursing students' competency in providing patient-centered care
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Immediately after the simulation session
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Jefferson Scale of Empathy Score
기간: Immediately after the simulation session
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Total score obtained from the Jefferson Scale of Empathy measuring nursing students' empathy levels toward patients
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Immediately after the simulation session
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Student Satisfaction and Self-Confidence in Learning Scale Score
기간: Immediately after the simulation session
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Total score obtained from the Student Satisfaction and Self-Confidence in Learning Scale measuring students' satisfaction and self-confidence following simulation
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Immediately after the simulation session
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Perceived Reality of Simulation
기간: Immediately after the simulation session
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Semi-structured interview responses assessing students' perceived realism of the simulation experience
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Immediately after the simulation session
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공동 작업자 및 조사자
수사관
- 수석 연구원: ECEM OZGUL, PhD, Atilim University School of Health Sciences, Department of Nursing
간행물 및 유용한 링크
일반 간행물
- Kim J, Park JH, Shin S. Effectiveness of simulation-based nursing education depending on fidelity: a meta-analysis. BMC Med Educ. 2016 May 23;16:152. doi: 10.1186/s12909-016-0672-7.
- Britz V, Sterz J, Koch Y, Schreckenbach T, Stefanescu MC, Zinsser U, Verboket RD, Sommer K, Ruesseler M. Impact of simulated patient-based communication training vs. real patient-based communication training on empathetic behaviour in undergraduate students - a prospective evaluation study. BMC Med Educ. 2024 Aug 12;24(1):870. doi: 10.1186/s12909-024-05801-8.
- Karaçay, Pelin, and Hatice Kaya. "Simulasyonla Egitimde Kullanilan Ogrenci Memnuniyeti ve Ogrenmede Kendine Guven Olcegi'nin Turkce'ye Uyarlanmasi/The Turkish Adaptation of the Student Satisfaction and Self-Confidence Learning Scale Used in Simulation Education." Florence Nightingale Journal of Nursing 25.2 (2017): 95-104.
- Yanik, Aygül, and Sefa Saygili. "Validity and reliability of the Turkish version of jefferson scale of empathy for nursing students." Turkiye Klinikleri Journal of Medical Sciences 34.1 (2014): 111-119.
- Saygılı, Meltem, Ahmet Kar, and Özgür Uğurluoğlu. "Hasta merkezli bakım yetkinlik ölçeği: Türkçe geçerlilik ve güvenilirlik çalışması." Süleyman Demirel Üniversitesi Sağlık Bilimleri Dergisi 11.4 (2020): 416-426.
- Akpinar Soylemez B, Ozgul E, Akyol MA, Kucukguclu O. Effectiveness of the aged simulation suit on undergraduate nursing students' attitudes and empathy toward older adults: A systematic review and meta-analysis. Nurse Educ Pract. 2024 May;77:103990. doi: 10.1016/j.nepr.2024.103990. Epub 2024 May 7.
- Cant RP, Cooper SJ. Use of simulation-based learning in undergraduate nurse education: An umbrella systematic review. Nurse Educ Today. 2017 Feb;49:63-71. doi: 10.1016/j.nedt.2016.11.015. Epub 2016 Nov 22.
- Shin S, Park JH, Kim JH. Effectiveness of patient simulation in nursing education: meta-analysis. Nurse Educ Today. 2015 Jan;35(1):176-82. doi: 10.1016/j.nedt.2014.09.009. Epub 2014 Oct 29.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- E-59394181-100-136938
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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간호교육에 대한 임상 시험
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Centre Hospitalier Universitaire Dijon완전한