Focus on Experienced Anxiety Related to an Emergency Depa... | NCT06202729

Studies
Focus on Experienced Anxiety Related to an Emergency Department Visit

NCT06202729

Sponsor

Frisius Medisch Centrum

Status

Completed

Last Update Posted

Mar 13, 2024Actual

Enrollment

139Actual

Phase

Not provided

Conditions

Fear

Interventions

Questionnaire

Countries

Netherlands

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2023Actual

Primary Completion Date

Dec 11, 2023Actual

Completion Date

Dec 11, 2023Actual

First Submitted Date

Dec 15, 2023

First Submission Date that Met QC Criteria

Jan 1, 2024

First Posted Date

Jan 11, 2024Actual

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

Mar 12, 2024

Last Update Posted Date

Mar 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of the present study is to determine the prevalence of anxiety in adult patients attending the ED of the Medical Centre Leeuwarden.

Detailed Description

Determination of the prevalence of anxiety in adult patients attending the ED of the Medical Centre Leeuwarden. Secondarily, the common causes of anxiety and the effect of anxiety on the time of presentation to the ED and perceived pain will be investigated. In addition to gaining more insight into the relationship between the ED and anxiety, the study aims to raise awareness of anxiety among patients in the ED.

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

139Actual

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	GAD-7, VAS-A, NRS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of anxiety measured by GAD-7 and VAS-A	What is the prevalence of anxiety among adult patients in the ED?	Two weeks prior to ED presentation

Secondary Outcomes

Measure	Description	Time Frame
Timing ER visit	What influence does fear have on the timing of the ER visit?	1 Day
Start of fear (open question)	What was the moment when fear arised?

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years and older
Competent to decide on study participation
Written informed consent obtained

Exclusion Criteria:

Patients from who a Dutch questionnaire cannot be obtained (e.g. delirious, comatose, confused and non-Dutch speaking patients)
If the reason for ED presentation is: suicide, intoxication or reporting from a sexual violence center
Patients with an active eating disorder
Patient already included in this study
Objection to the use of patient data registered in the EPD

Accepts Healthy Volunteers

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

Adult patients visiting the ED.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MCLeeuwarden		Leeuwarden	Provincie Friesland	8934 AD	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided