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Effect of Virtual Reality During Femoral Sheath Removal

2026年6月11日 更新者:İrem Canavar、Hasan Kalyoncu University

The Effect of Virtual Reality Glasses During Femoral Sheath Removal on Pain, Anxiety, and Vital Signs in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial

This randomized controlled study was conducted to evaluate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were assigned to either a virtual reality intervention group or a control group receiving standard care. Pain, anxiety, and vital signs were assessed before, during, and after the procedure. The study aimed to determine whether virtual reality application could improve patient comfort and reduce procedure-related discomfort during femoral sheath removal.

研究概览

详细说明

Percutaneous coronary intervention is a commonly used invasive procedure in the diagnosis and treatment of coronary artery disease. Femoral sheath removal performed after the procedure may cause pain, anxiety, and hemodynamic changes in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and reduce procedure-related stress.

Virtual reality technology is considered an effective distraction method that may reduce pain perception and anxiety by directing patients' attention to immersive visual and auditory stimuli. Previous studies have demonstrated the positive effects of virtual reality applications during invasive and painful procedures.

This randomized controlled study aimed to investigate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were randomly assigned to either the intervention group receiving virtual reality application during femoral sheath removal or the control group receiving standard care. Pain intensity, anxiety levels, and vital signs were evaluated before, during, and after the procedure.

The findings of this study may contribute to evidence-based nursing interventions aimed at improving patient comfort during femoral sheath removal procedures.

研究类型

介入性

注册 (实际的)

60

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

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

不

描述

Inclusion Criteria:

  • Patients aged 18 years and older
  • Patients undergoing percutaneous coronary intervention via femoral access
  • Patients with only one femoral sheath catheter
  • Patients who did not receive analgesic medication before sheath removal
  • Patients without severe hemorrhage or major hematoma at the femoral sheath site
  • Patients able to communicate in Turkish
  • Patients without visual, hearing, or speech impairment
  • Patients without mental impairment affecting communication
  • Patients without psychiatric diagnosis and not using psychiatric medication

Exclusion Criteria:

  • Patients unwilling to participate or wishing to withdraw from the study at any stage

    • Patients who removed the virtual reality glasses during the intervention
    • Patients who experienced intolerance to virtual reality application (e.g., dizziness or nausea)

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Virtual Reality Group
Participants received virtual reality glasses during femoral sheath removal
Virtual reality glasses were used during femoral sheath removal.
其他:Control Group
Participants received routine care during femoral sheath removal
Participants received routine care during femoral sheath removal

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
Heart Rate
大体时间:Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Heart rate was measured in beats per minute using routine monitoring.
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Blood Pressure
大体时间:Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Systolic blood pressure and diastolic blood pressure were measured in mmHg using routine monitoring.
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Oxygen Saturation
大体时间:Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Oxygen saturation was measured as percent saturation using pulse oximetry.
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Body Temperature
大体时间:5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Body temperature was assessed using routine vital sign monitoring.
5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Pain Level
大体时间:5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Pain level was assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates severe pain. Higher scores indicate greater pain severity.
5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Anxiety Level
大体时间:Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
Anxiety level was assessed using the State Anxiety Inventory (STAI). Higher scores indicate higher anxiety levels.
Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal

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。

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)

2025年7月1日

初级完成 (实际的)

2026年1月5日

研究完成 (实际的)

2026年1月5日

研究注册日期

首次提交

2026年5月8日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • HKU-2025/069

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 privacy and confidentiality considerations

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

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