- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06202729
Focus on Experienced Anxiety Related to an Emergency Department Visit (FEAR-ED)
March 12, 2024 updated by: Medical Centre Leeuwarden
The aim of the present study is to determine the prevalence of anxiety in adult patients attending the ED of the Medical Centre Leeuwarden.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
139
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Friesland
-
Leeuwarden, Friesland, Netherlands, 8934 AD
- MCLeeuwarden
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients visiting the ED.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of anxiety measured by GAD-7 and VAS-A
Time Frame: Two weeks prior to ED presentation
|
What is the prevalence of anxiety among adult patients in the ED?
|
Two weeks prior to ED presentation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timing ER visit
Time Frame: 1 Day
|
What influence does fear have on the timing of the ER visit?
|
1 Day
|
|
Start of fear (open question)
Time Frame: 1 Day
|
What was the moment when fear arised?
|
1 Day
|
|
Influence of pain (NRS) on fear (GAD-7)
Time Frame: 1 Day
|
What is the influence of pain on fear experienced?
|
1 Day
|
|
Cause of fear (open question)
Time Frame: 1 Day
|
What is the cause of fear?
|
1 Day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2023
Primary Completion (Actual)
December 11, 2023
Study Completion (Actual)
December 11, 2023
Study Registration Dates
First Submitted
December 15, 2023
First Submitted That Met QC Criteria
January 1, 2024
First Posted (Actual)
January 11, 2024
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCLSEH1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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