Augmented RealityNCT07677943
Exploring the Effects of Augmented Reality Educational Videos on Anxiety in Patients Undergoing Cardiac Catheterization
A study testing Augmented Reality and Paper-based education in people with Augmented Reality and Cardiac Catheterization, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Augmented Reality, Cardiac Catheterization, Anxiety
- What is being tested?
- Augmented Reality and Paper-based education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 May 2025to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chung Shan Medical University Hospital
Taichung, South Dist, 402306
About this study
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.
Read more
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?
- Conditions
- Augmented Reality, Cardiac Catheterization, Anxiety
- Being tested
- Augmented Reality, Paper-based education
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented RealityOther
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 educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Other: Augmented Reality; Other: Paper-based education |
| Control Group | Active comparator | Not described Receives: Other: Paper-based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety scores measured by the Visual Analog Scale for Anxiety (VAS-A)
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.
Measured: 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)
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.
Measured: pre-intervention, and within 6 hours after completion of after procedure
Secondary outcomes (4)
Change in heart rate
Assess the level of physiological anxiety through changes in heart rate.
Measured: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
Change in systolic blood pressure
Assess the level of physiological anxiety through change in systolic blood pressure
Measured: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
Change in diastolic blood pressure
Assess the level of physiological anxiety through change in diastolic blood pressure
Measured: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
Change in respiratory rate
Assess the level of physiological anxiety through change in respiratory rate
Measured: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start7 May 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Augmented RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677943
- Sponsor's protocol ID
- CSH-2025-A-033
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Augmented Reality Educational Videos on Anxiety in Patients Undergoing Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT07677943
- Acronym / sponsor ID
- CSH-2025-A-033
- Conditions
- Augmented Reality, Cardiac Catheterization, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Augmented Reality, Other: Paper-based education |
| Control Group | Active comparator | Other: Paper-based education |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented RealityThe 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. | Other | Experimental Group |
| Paper-based educationRoutine 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. | Other | Control Group, Experimental Group |
Primary outcome
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.
4 secondary outcomes
Change in heart rate
Time frame: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
Change in systolic blood pressure
Time frame: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
Change in diastolic blood pressure
Time frame: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
Change in respiratory rate
Time frame: pre-intervention, immediately after the intervention, and within 6 hours after completion of after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality and Paper-based education in people with Augmented Reality and Cardiac Catheterization, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.