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临床试验/NCT07677943
NCT07677943已完成不适用

Exploring the Effects of Augmented Reality Educational Videos on Anxiety in Patients Undergoing Cardiac Catheterization

Chung Shan Medical University1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2025年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
1
主要终点
Change in anxiety scores measured by the Visual Analog Scale for Anxiety (VAS-A)

研究概览

简要总结

This study investigates the effectiveness of augmented reality educational videos in improving anxiety among patients undergoing cardiac catheterization.

The study participants were patients undergoing cardiac catheterization. The control group received routine care, which included standard paper-based educational materials for cardiac catheterization. The experimental group received routine care in addition to viewing cardiac catheterization educational videos through an augmented reality (AR) application.

The Visual Analog Scale for Anxiety (VAS-A), the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), and physiological indicators were used to assess participants' subjective and objective levels of anxiety. Assessments and measurements were conducted at three time points: before the intervention, immediately after the intervention, and within 6 hours after completion of cardiac catheterization. Due to the characteristics of the HADS-A subscale, it was administered only at two time points: before the intervention and within 6 hours after completion of cardiac catheterization.

The main research questions addressed in this study are:

  • What are the differences in anxiety levels among cardiac catheterization patients based on their basic characteristics?
  • How effective is the AR intervention in reducing anxiety among patients undergoing cardiac catheterization?
  • What are the effects of AR intervention on patients' anxiety levels (VAS-A, HADS-A) and physiological indicators before the intervention, after the intervention, and after the completion of the cardiac catheterization procedure?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis requiring conventional cardiac catheterization, such as ischemic heart disease (ICD-10 code: I20-I25.0).
  • Individuals aged 20-75 years with full capacity for civil conduction.
  • Individuals eligible for AR (Ambient Neurological) experience and without a history of neurological disorders, such as visual or auditory impairments, or epilepsy.

排除标准

  • Emergency cardiac catheterization
  • History of anxiety disorder, depression, or arrhythmia (e.g., atrial fibrillation)
  • Regular use of heart rate suppressants, anti-anxiety medications, and sedatives
  • Patients who have only undergone peripheral arteriovenous angiography

结局指标

主要结局

Change in anxiety scores measured by the Visual Analog Scale for Anxiety (VAS-A)

时间窗: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure

The Visual Analog Scale for Anxiety (VAS-A) is used to assess the subjective level of anxiety. It consists of a continuous 100-mm horizontal line ranging from 0 to 100 mm, with 0 mm representing no anxiety and 100 mm representing extreme anxiety. Higher scores indicate greater levels of anxiety. A VAS-A score of ≥50 mm is considered to represent clinically significant anxie.

Change in anxiety scores measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)

时间窗: pre-intervention, and within 6 hours after completion of after procedure

The Hospital Anxiety and Depression Scale (HADS) consists of 14 items, including 7 anxiety items and 7 depression items. In this study, only the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A), which contains 7 items, was used. The HADS-A is scored using a Likert-type scale, with total scores ranging from 0 to 21. Higher scores indicate greater levels of anxiety. Scores of 0-7 indicate normal anxiety levels, scores of 8-10 indicate mild anxiety, and scores of 11 or higher indicate severe anxiety.

次要结局

  • Change in heart rate(pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure)
  • Change in systolic blood pressure(pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure)
  • Change in diastolic blood pressure(pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure)
  • Change in respiratory rate(pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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