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Effects of Simulation Fidelity on Patient-Centered Care Competency, Empathy, and Learning Outcomes in Nursing Students: A Randomized Controlled Trial

2026年6月4日 更新者:Atılım University

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

This randomized controlled trial examines the effects of simulation fidelity on nursing students' patient-centered care competency, empathy, learning self-confidence, and satisfaction. Participants will be randomly assigned to two groups: one group will practice with a standardized patient (actor) and the other with a manikin in a myocardial infarction scenario. All sessions will follow the same structured simulation protocol including briefing, simulation, and debriefing phases. The study aims to provide evidence on whether the type of simulated patient affects learning outcomes in nursing education.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

45

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Ankara、土耳其(türkiye)、06830
        • Atilim University, Faculty of Health Sciences, Nursing Skills Laboratory

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
有源比较器:Manikin Group
Participants in this group will perform the same myocardial infarction nursing care scenario using a high-fidelity manikin simulation.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Patient-Centered Care Competency Scale Score
大体时间:Immediately after the simulation session
Total score obtained from the Patient-Centered Care Competency Scale measuring nursing students' competency in providing patient-centered care
Immediately after the simulation session
Jefferson Scale of Empathy Score
大体时间:Immediately after the simulation session
Total score obtained from the Jefferson Scale of Empathy measuring nursing students' empathy levels toward patients
Immediately after the simulation session

次要结果测量

结果测量
措施说明
大体时间
Student Satisfaction and Self-Confidence in Learning Scale Score
大体时间:Immediately after the simulation session
Total score obtained from the Student Satisfaction and Self-Confidence in Learning Scale measuring students' satisfaction and self-confidence following simulation
Immediately after the simulation session
Perceived Reality of Simulation
大体时间:Immediately after the simulation session
Semi-structured interview responses assessing students' perceived realism of the simulation experience
Immediately after the simulation session

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:ECEM OZGUL, PhD、Atilim University School of Health Sciences, Department of Nursing

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月12日

初级完成 (估计的)

2026年7月30日

研究完成 (估计的)

2026年7月30日

研究注册日期

首次提交

2026年6月4日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月4日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared due to ethical and legal obligations regarding participant confidentiality. Data were collected from undergraduate nursing students under informed consent agreements that do not include provisions for external data sharing. All data are stored and processed in accordance with Turkish Personal Data Protection Law (KVKK - Law No. 6698).

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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