Exploring the Effects of Augmented Reality Educational Videos on Anxiety in Patients Undergoing Cardiac Catheterization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Change in anxiety scores measured by the Visual Analog Scale for Anxiety (VAS-A)
Study Overview
Brief Summary
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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Experimental Group
Intervention: Paper-based education (Other)
Experimental Group
Intervention: Augmented Reality (Other)
Control Group
Intervention: Paper-based education (Other)
Outcomes
Primary Outcomes
Change in anxiety scores measured by the Visual Analog Scale for Anxiety (VAS-A)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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)