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Scenario-Based Hybrid Simulation for Patient Education in Assisted Reproductive Treatment

2026年9月30日 更新者:Duzce University

The Effect of a Scenario-Based Hybrid Simulation Aimed at Educating Patients Receiving Assisted Reproductive Treatment on Nursing Students' Anxiety, Effective Communication, Self-Efficacy, Knowledge, and Skills

This study aims to evaluate the effect of a scenario-based hybrid simulation designed for patient education in assisted reproductive treatment on nursing students' anxiety, effective communication, self-efficacy, knowledge, and skills. The study will include third-year nursing students enrolled in the Assisted Reproductive Technologies and Nursing course. Participants will receive six weeks of theoretical and video-based education followed by two scenario-based hybrid simulation sessions conducted four weeks apart. Outcomes will be assessed at four time points (T0, T1, T2, and T3). A preliminary application is planned with 6 students, followed by the main study with 30 students.

研究概览

详细说明

This study will use a single-group quasi-experimental design with repeated measurements. Participants will be third-year nursing students enrolled in the Assisted Reproductive Technologies and Nursing course at Düzce University Faculty of Health Sciences. After providing informed consent, baseline assessments (T0) will be conducted using the Introductory Information Form, anxiety, effective communication, self-efficacy, and assisted reproductive technologies knowledge measures.

Participants will then receive six weeks of structured theoretical education and video-based training. At the end of this period, the same outcome measures will be administered at T1. Participants will subsequently take part in the first scenario-based hybrid simulation involving a standardized female patient, a standardized male partner, and an injection model. The simulation will focus on assisted reproductive treatment stages, patient education, gonadotropin medication administration, and assessment of ovarian hyperstimulation syndrome (OHSS), followed by debriefing.

Immediately after the first simulation, T2 assessments will be conducted, including anxiety, effective communication, self-efficacy, knowledge, and skill assessment. Four weeks later, participants will complete a second scenario-based hybrid simulation with the same learning objectives, followed by debriefing and the final T3 assessment.

A preliminary application is planned with 6 nursing students to evaluate the feasibility of the educational content, simulation scenario, assessment instruments, and implementation process. These students will not be included in the main study. The main study is planned with 30 eligible nursing students.

研究类型

介入性

注册 (估计的)

30

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。

学习联系方式

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Being a third-year undergraduate nursing student.
  • Being enrolled in the Assisted Reproductive Technologies and Nursing course.
  • Voluntarily agreeing to participate in the study.
  • Having no previous experience with scenario-based or hybrid simulation training on assisted reproductive treatment.

Exclusion Criteria:

  • Not completing the simulation sessions.
  • Not completing any of the required data collection assessments.
  • Withdrawing from the study voluntarily.

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:不适用
  • 介入模型:单组作业
  • 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:Scenario-Based Hybrid Simulation

Participants will receive six weeks of structured theoretical and video-based education followed by two scenario-based hybrid simulation sessions conducted four weeks apart. The simulations will involve a standardized female patient, a standardized male partner, and an injection model. Students will provide education regarding assisted reproductive treatment, gonadotropin medication administration, and ovarian hyperstimulation syndrome.

Participants will receive six weeks of structured theoretical and video-based education on assisted reproductive technologies and nursing, followed by two scenario-based hybrid simulation sessions conducted four weeks apart. Each simulation will involve a standardized female patient, a standardized male partner, and an injection model. Students will provide education on assisted reproductive treatment stages, the role of the male partner, gonadotropin medication administration, and risk factors and signs and symptoms of ovarian hyperstimulation syndrome. Each simulation will be followed by a structured debriefing session.

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
Change in Assisted Reproductive Technologies Knowledge Score
大体时间:At baseline (Day 0), after 6 weeks of theoretical and video-based education (Week 6), immediately after the first simulation session (Week 8), and immediately after the second simulation session, conducted 4 weeks after the first simulation (Week 12).

Change in students' knowledge regarding assisted reproductive technologies, assessed using the researcher-developed Assisted Reproductive Technologies Knowledge Test. The knowledge test was developed by the researchers based on the relevant literature and study objectives. The content validity of the test was evaluated through expert review, and a preliminary application was conducted with students from a different group who were not included in the main study. Item difficulty analyses were performed based on the preliminary application to evaluate the appropriateness and discriminatory characteristics of the test items. Higher scores indicate a higher level of knowledge regarding assisted reproductive technologies.

At baseline (Day 0), after 6 weeks of theoretical and video-based education (Week 6), immediately after the first simulation session (Week 8), and immediately after the second simulation session, conducted 4 weeks after the first simulation (Week 12).

次要结果测量

结果测量
措施说明
大体时间
Change in Effective Communication Skills
大体时间:At baseline (Day 0), after 6 weeks of theoretical and video-based education (Week 6), immediately after the first simulation session (Week 8), and immediately after the second simulation session, conducted 4 weeks after the first simulation (Week 12).

Effective communication skills will be assessed at T0, T1, T2, and T3 using the Effective Communication Skills Scale. The scale consists of 34 items and five subdimensions: ego-enhancing language, active listening, self-awareness/self-disclosure, empathy, and use of "I" language. It uses a 5-point Likert-type response format, with higher scores indicating better effective communication skills.Cronbach alfa value is 0.93 for the full scale, and 0.85, 0.90, 0.78, 0.91, and 0.53 for the Ego Supportive Language, Active-Participative Listening, Self-recognition/Self-disclosure, Empathy, and I-language sub-dimensions, respectively.

At baseline (Day 0), after 6 weeks of theoretical and video-based education (Week 6), immediately after the first simulation session (Week 8), and immediately after the second simulation session, conducted 4 weeks after the first simulation (Week 12).
Change in Anxiety Level
大体时间:At baseline (Day 0), after 6 weeks of theoretical and video-based education (Week 6), immediately after the first simulation session (Week 8), and immediately after the second simulation session, conducted 4 weeks after the first simulation (Week 12).

Anxiety will be assessed at T0, T1, T2, and T3 using the State-Trait Anxiety Inventory (STAI). The STAI is a 40-item self-report instrument consisting of two subscales: State Anxiety and Trait Anxiety, with 20 items in each subscale. Items are rated on a 4-point response scale. Higher scores indicate higher levels of anxiety. The Turkish version of the STAI has been adapted and validated for use in Turkish populations. Cronbach's alpha coefficients were reported as 0.92 for state anxiety and 0.87 for trait anxiety.

At baseline (Day 0), after 6 weeks of theoretical and video-based education (Week 6), immediately after the first simulation session (Week 8), and immediately after the second simulation session, conducted 4 weeks after the first simulation (Week 12).
Change in Self-Efficacy
大体时间:At baseline (Day 0), after 6 weeks of theoretical and video-based education (Week 6), immediately after the first simulation session (Week 8), and immediately after the second simulation session, conducted 4 weeks after the first simulation (Week 12).

Self-efficacy will be assessed at T0, T1, T2, and T3 using the Student Self-Efficacy Scale. The scale consists of 10 items and has a single-factor structure. It is a self-report measure developed to assess students' perceived self-efficacy. Higher scores indicate higher levels of self-efficacy. The Turkish version of the scale has demonstrated acceptable validity and reliability among undergraduate nursing students.The Cronbach's alpha coefficient was 0.81, while corrected item-total correlations ranged from 0.45 to 0.56.

At baseline (Day 0), after 6 weeks of theoretical and video-based education (Week 6), immediately after the first simulation session (Week 8), and immediately after the second simulation session, conducted 4 weeks after the first simulation (Week 12).
Change in Simulation Skill Performance
大体时间:Skills will be assessed at two time points: immediately after the first simulation (Week 8) and immediately after the second simulation (Week 12), with a 4-week interval between assessments.

Simulation skill performance will be assessed during the first and second simulation sessions (T2 and T3) using the researcher-developed Skill Assessment Form. The form was developed based on the study objectives and relevant literature, and its content was evaluated through expert review. The form evaluates students' performance in communicating with the female patient and male partner, explaining the stages of assisted reproductive treatment and the role of the male partner, preparing and administering gonadotropin medication, and providing education on medication administration. Higher scores indicate better performance.

Skills will be assessed at two time points: immediately after the first simulation (Week 8) and immediately after the second simulation (Week 12), with a 4-week interval between assessments.

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:Hilal Karadeniz、Duzce University
  • 研究主任:Atiye Erbaş, PhD、Duzce University

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。

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 (估计的)

2026年10月1日

初级完成 (估计的)

2027年1月15日

研究完成 (估计的)

2027年6月15日

研究注册日期

首次提交

2026年9月23日

首先提交符合 QC 标准的

2026年9月30日

首次发布 (实际的)

2026年10月1日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年9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 with other researchers because the study involves a relatively small group of nursing students from a single institution. Sharing individual-level data may increase the risk of participant identification and compromise confidentiality and privacy, particularly when combined with participants' demographic and academic characteristics. Therefore, individual participant data will be kept confidential and will not be made available for external research use.

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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