The Impact of Video Information on Preoperative Anxiety i... | NCT04473495

Studies
The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.

NCT04473495

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jul 16, 2020Actual

Enrollment

74Estimated

Phase

Not provided

Conditions

Coronary Artery Disease
Atrial Fibrillation
Atrial Flutter

Interventions

educational video

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2020Estimated

Primary Completion Date

Sep 2020Estimated

Completion Date

Oct 2020Estimated

First Submitted Date

May 5, 2020

First Submission Date that Met QC Criteria

Jul 15, 2020

First Posted Date

Jul 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2020

Last Update Posted Date

Jul 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the impact of educative videos on anxiety for patients entering hospital for cardiology intervention

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

74Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
video		patients who enjoyed an educational video	Device: educational video
control		patients who didn't enjoy any educational video

Interventions

Name	Type	Description	Arm Group Labels	Other Names
educational video	Device	educational video before intervention	video

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anxiety	anxiety measured with STAI Y-A questionnaire	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient entering hospitalisation in cardiology department for a cardiology intervention.

Exclusion Criteria:

protected person.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient entering hospitalisation in cardiology department for a cardiology intervention

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ugo Righetto	Contact	0033383153256		ugo.righetto@gmail.com
Jean-Marc Sellal	Contact	0033383153256

Overall Officials

Name	Affiliation	Role
Jean-Marc Sellal	Central Hospital, Nancy, France	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D001281	Atrial Fibrillation
D001282	Atrial Flutter

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided