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临床试验/NCT07747051
NCT07747051尚未招募不适用

The Effect of Scenario-Based Simulation Training for Nutritional Counseling During Pregnancy on Nursing Students' Anxiety Levels, Self-Efficacy Perceptions, and Clinical Skill Performance: A Randomized Controlled Trial

Ayşenur Karakuş0 个研究点目标入组 52 人开始时间: 2026年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
主要终点
Clinical Skill Performance

研究概览

简要总结

The Effect of Scenario-Based Simulation Training for Nutritional Counseling During Pregnancy on Nursing Students' Anxiety Levels, Self-Efficacy Perceptions, and Clinical Skill Performance: A Randomized Controlled Trial

Research Hypotheses

H1: Scenario-based simulation training significantly reduces anxiety levels among nursing students.

H2: Scenario-based simulation training significantly increases nursing students' perceived self-efficacy.

H3: Scenario-based simulation training significantly improves nursing students' clinical skill performance.

H0₁: Scenario-based simulation training has no statistically significant effect on nursing students' anxiety levels.

H0₂: Scenario-based simulation training has no statistically significant effect on nursing students' perceived self-efficacy.

H0₃: Scenario-based simulation training has no statistically significant effect on nursing students' clinical skill performance.

详细描述

Participants and Sampling The study population consisted of undergraduate nursing students enrolled in the Faculty of Health Sciences, Department of Nursing, at Eskişehir Osmangazi University. The study sample comprised 52 nursing students who agreed to participate during the study period and met the eligibility criteria. Participants were randomly assigned to either the intervention group (n = 26) or the control group (n = 26) using a simple randomization procedure.

The required sample size was determined using G*Power software (version 3.1.9.7). The calculation was based on a moderate-to-large effect size (d = 0.70), a significance level of α = .05, and a statistical power of 0.80. The analysis indicated that a minimum of 23 participants per group was required. Considering the possibility of missing data and participant attrition, the sample size was increased to 26 students per group.

Purposive sampling, a non-probability sampling method, was employed to recruit participants. This sampling strategy was selected to ensure the inclusion of nursing students who had received theoretical instruction in pregnancy nutrition counseling and were eligible to participate in the simulation-based educational intervention.

Eligible participants were undergraduate nursing students who voluntarily agreed to participate in the study and had not previously received simulation training on a similar topic. Students who failed to participate throughout the study or who submitted incomplete pretest or posttest questionnaires were excluded from the analysis.

Randomization and Blinding Participants were allocated to the intervention and control groups using a simple randomization procedure. After eligible and consenting students had been assigned identification numbers, a computer-generated random number sequence was used to allocate participants to either the intervention group (n = 26) or the control group (n = 26). The randomization process was performed by an independent researcher who was not directly involved in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergraduate nursing students enrolled in the Department of Nursing.
  • Willingness to participate in the study and provision of written informed consent.
  • No previous participation in scenario-based simulation training on pregnancy nutrition counseling or a similar topic.

排除标准

  • Failure to attend the intervention or complete the study procedures.
  • Incomplete completion of the pretest or posttest questionnaires.
  • Withdrawal from the study at any stage

研究组 & 干预措施

Experimental

Experimental

Data collection was conducted after obtaining ethical approval and institutional permission. Participants were informed about the study and provided written informed consent before completing the pretest assessing anxiety and perceived self-efficacy.

Following the pretest, participants in the intervention group received a 20-minute scenario-based simulation training on pregnancy nutrition counseling, designed to simulate an outpatient clinic setting. This was followed by a 20-minute structured debriefing session facilitated by the researchers.

After the intervention, participants completed the posttest to evaluate changes in anxiety and perceived self-efficacy. Clinical skill performance was assessed using the Pregnancy Nutrition Counseling Skills Checklist developed by the researchers.

干预措施: Participants completed the pretest, received a scenario-based pregnancy nutrition counseling simulation, and then completed the posttest and clinical skill assessment. (Behavioral)

Control

No Intervention

The control group received the standard theoretical education on pregnancy nutrition counseling routinely provided in the nursing curriculum and did not participate in the scenario-based simulation training.

结局指标

主要结局

Clinical Skill Performance

时间窗: Immediately after the intervention

Clinical skill performance will be evaluated using the Pregnancy Nutrition Counseling Skills Checklist, an 18-item instrument developed by the researchers based on the relevant literature. The checklist assesses students' competency in providing pregnancy nutrition counseling, including therapeutic communication, history taking, assessment of maternal nutritional status, identification of gestational diabetes mellitus (GDM) risk factors, development of individualized nutrition counseling plans, application of motivational interviewing techniques, patient education, and follow-up planning. Each item is rated as "Performed," "Partially Performed," or "Not Performed." Students are expected to demonstrate these competencies while managing a standardized pregnancy nutrition counseling scenario. Total clinical skill performance scores obtained after the intervention will be compared between the intervention and control groups, with higher scores indicating better clinical performance.

次要结局

  • Change in State Anxiety Level(Immediately before and immediately after the intervention)
  • Change in Perceived Self-Efficacy(Immediately before and immediately after the intervention)

研究者

发起方
Ayşenur Karakuş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ayşenur Karakuş

Research Assistant

Eskisehir Osmangazi University

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