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Completed

NCT Number: NCT07677943

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

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?

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Key information

Conditions

Augmented Reality Anxiety Anxiety Disorders Cardiac Catheterization Mental Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University Hospital

Taichung, South Dist, 402306, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmented Reality

Other

The experimental group received routine care (paper-based education) before cardiac catheterization and additionally viewed a cardiac catheterization educational video through an augmented reality (AR) application. The AR intervention consisted of an interactive educational video played on a tablet computer for participants to watch.

The video content was developed based on findings from the literature review, hospital educational leaflets, and manuals. A professional company was commissioned to create the graphics and programming and develop the AR application. The video presented information related to cardiac catheterization through real-life images, illustrations, and voice narration, with a total duration of approximately 8 minutes.

To ensure the quality and rigor of the intervention tool, three cardiology experts were invited to evaluate the content. The Content Validity Index (CVI) of the intervention was 0.85.

Paper-based education

Other

Routine care consisted of verbal education using an educational leaflet. The leaflet was based on the standard educational materials routinely used in the cardiology department of the hospital and was developed by the hospital nursing department according to clinical practice and relevant care guidelines.

The content of the educational leaflet included the causes and symptoms of myocardial infarction, pre-procedure preparation for cardiac catheterization, post-procedure puncture wound care, and key points for self-care after discharge. During the intervention process, participants received verbal education from the researcher before cardiac catheterization, accompanied by explanations using the educational leaflet. The educational session lasted approximately 10 minutes, and participants were encouraged to ask questions to enhance their understanding of the educational content.

Primary outcomes

  1. 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.

  2. 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

  1. Change in heart rate

    Time frame: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure

    Assess the level of physiological anxiety through changes in heart rate.

  2. Change in systolic blood pressure

    Time frame: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure

    Assess the level of physiological anxiety through change in systolic blood pressure

  3. Change in diastolic blood pressure

    Time frame: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure

    Assess the level of physiological anxiety through change in diastolic blood pressure

  4. Change in respiratory rate

    Time frame: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure

    Assess the level of physiological anxiety through change in respiratory rate

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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