- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424482
Educational Video to Improve Understanding and Reduce Anxiety in Heart Attack Patients (VID-ACS)
Video-Based Information to Improve Understanding and Reduce Anxiety in Patients With Acute Coronary Syndrome
Patients who are diagnosed with a heart attack are often confronted with an unexpected hospital admission and an urgent heart catheterization. In this stressful situation, anxiety is common and understanding of the procedure may be limited, even after standard verbal and written explanations.
This study investigates whether a short educational video, shown in addition to standard medical information, can help patients better understand the heart catheterization procedure and reduce anxiety before the intervention. Patients will be randomly assigned to receive either standard information alone or standard information plus the educational video.
The study will assess patients' understanding of the procedure, their level of anxiety, and their satisfaction with the information provided. The results may help improve patient education and support in acute cardiac care settings.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients admitted with acute coronary syndrome require urgent heart catheterization under stressful and unfamiliar circumstances. Anxiety levels are often elevated, and the ability to process and retain medical information may be reduced. Standard patient education is typically provided verbally and in written form, but time constraints and the acute clinical setting may limit its effectiveness.
The purpose of this randomized controlled study is to evaluate the effect of a short, standardized educational video shown in addition to standard care. The video is designed to provide structured information about the heart catheterization procedure, including its purpose, key steps, typical visual impressions, and immediate post-procedural care, without minimizing potential risks. The intervention is intended to complement, not replace, routine physician-led informed consent.
Eligible patients with acute coronary syndrome who are undergoing heart catheterization for the first time will be enrolled and randomly assigned to either standard information alone or standard information plus the educational video.
The primary objective is to determine whether the educational video improves patients' understanding of the procedure. Secondary objectives include assessing its effect on anxiety levels and patient satisfaction.
By focusing on an easily scalable educational intervention, this study aims to provide evidence for improving patient-centered communication in acute cardiac care. If effective, the approach may be implemented into routine clinical practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tobias Schreiber
- Phone Number: 0049450513702
- Email: tobias.schreiber@dhzc-charite.de
Study Locations
-
-
-
Berlin, Germany
- Deutsches Herzzentrum der Charité (DHZC)
-
Contact:
- Schreiber
- Phone Number: 004930450513702
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- first-time Acute Coronary Syndrome
- Diagnosis of Acute Coronary Syndrome
Exclusion Criteria:
- Prior heart catheterization or coronary angiography
- Severe neurocognitive impairment that precludes valid participation in the study or informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard informed consent
|
|
|
Experimental: Educational Video Plus Standard Information
|
Participants assigned to the intervention group will receive standard verbal and written medical information according to routine clinical practice.
In addition, they will watch a short, standardized educational video explaining the heart catheterization procedure, including its purpose, main steps, typical visual impressions, and immediate post-procedural care.
The video is intended to complement, not replace, physician-led informed consent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient knowledge
Time Frame: Within 24 hours before coronary angiography
|
Multiple Choice test before coronary angiography.
A higher test result indicates better understanding.
|
Within 24 hours before coronary angiography
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA2/111/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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