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

30 giugno 2026 aggiornato da: Chung Shan Medical University

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?

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

107

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • South Dist
      • Taichung, South Dist, Taiwan, 402306
        • Chung Shan Medical University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Gruppo sperimentale

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.

Comparatore attivo: Gruppo di controllo

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in anxiety scores measured by the Visual Analog Scale for Anxiety (VAS-A)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in heart rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 maggio 2025

Completamento primario (Effettivo)

28 novembre 2025

Completamento dello studio (Effettivo)

28 novembre 2025

Date di iscrizione allo studio

Primo inviato

31 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 giugno 2026

Primo Inserito (Effettivo)

1 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CSH-2025-A-033

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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