Coronary Artery DiseaseVATICNCT04473495
The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.
An observational study of Coronary Artery Disease and Atrial Fibrillation, run by Central Hospital, Nancy, France.
Trial summary
This study evaluates the impact of educative videos on anxiety for patients entering hospital for cardiology intervention Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation, Atrial Flutter
- What is being tested?
- educational video
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Oct 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patient entering hospitalisation in cardiology department for a cardiology intervention
Who may be able to join
- patient entering hospitalisation in cardiology department for a cardiology intervention.
Who cannot join
- protected person.
Trial locations and contacts
No sites are listed yet.
Jean-Marc Sellal contact
About this study
This study evaluates the impact of educative videos on anxiety for patients entering hospital for cardiology intervention
- Conditions
- Coronary Artery Disease, Atrial Fibrillation, Atrial Flutter
- Being tested
- educational video
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational videoDevice
educational video before intervention
| Study group | Role | What they receive |
|---|---|---|
| video | patients who enjoyed an educational video Receives: Device: educational video | |
| control | patients who didn't enjoy any educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety
anxiety measured with STAI Y-A questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study startAug 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Sellal, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473495
- Sponsor's protocol ID
- 2019PI013
- Acronym
- VATIC
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.
- ClinicalTrials.gov ID
- NCT04473495
- Acronym / sponsor ID
- VATIC / 2019PI013
- Conditions
- Coronary Artery Disease, Atrial Fibrillation, Atrial Flutter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 16 Jul 2020 (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 evaluates the impact of educative videos on anxiety for patients entering hospital for cardiology intervention
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video | – | Device: educational videopatients who enjoyed an educational video |
| control | – | –patients who didn't enjoy any educational video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient entering hospitalisation in cardiology department for a cardiology intervention
Key inclusion criteria (1 listed)
- patient entering hospitalisation in cardiology department for a cardiology intervention.
Key exclusion criteria (1 listed)
- protected person.
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 |
|---|---|---|
| educational videoeducational video before intervention | Device | video |
Primary outcome
anxiety
Time frame: 1 year
anxiety measured with STAI Y-A questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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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.
Jean-Marc Sellal contact
Jean-Marc Sellal principal investigator
Central Hospital, Nancy, France
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atrial Fibrillation, run by Central Hospital, Nancy, France.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ugo Righetto (0033383153256, ugo.righetto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety (time frame: 1 year). 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 16 Jul 2020.