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?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
South Dist
-
Taichung, South Dist, Taïwan, 402306
- Chung Shan Medical University Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Groupe expérimental
|
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. 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. |
|
Comparateur actif: Groupe de contrôle
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in anxiety scores measured by the Visual Analog Scale for Anxiety (VAS-A)
Délai: 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.
|
pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
|
|
Change in anxiety scores measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Délai: 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.
|
pre-intervention, and within 6 hours after completion of after procedure
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in heart rate
Délai: 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.
|
pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
|
|
Change in systolic blood pressure
Délai: 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
|
pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
|
|
Change in diastolic blood pressure
Délai: 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
|
pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
|
|
Change in respiratory rate
Délai: 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
|
pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CSH-2025-A-033
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .