FearFEAR-EDNCT06202729
Focus on Experienced Anxiety Related to an Emergency Department Visit
An observational study of Fear, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear
- What is being tested?
- Questionnaire
- How many people
- 139 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Nov 2023to 11 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients visiting the ED.
Who may be able to join
- Age 18 years and older
- Competent to decide on study participation
- Written informed consent obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to determine the prevalence of anxiety in adult patients attending the ED of the Medical Centre Leeuwarden.
Read the 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.
- Conditions
- Fear
- Being tested
- Questionnaire
- Keywords
- Fear, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
GAD-7, VAS-A, NRS
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anxiety measured by GAD-7 and VAS-A
What is the prevalence of anxiety among adult patients in the ED?
Measured: Two weeks prior to ED presentation
Secondary outcomes (4)
Timing ER visit
What influence does fear have on the timing of the ER visit?
Measured: 1 Day
Start of fear (open question)
What was the moment when fear arised?
Measured: 1 Day
Influence of pain (NRS) on fear (GAD-7)
What is the influence of pain on fear experienced?
Measured: 1 Day
Cause of fear (open question)
What is the cause of fear?
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start8 Nov 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202729
- Sponsor's protocol ID
- MCLSEH1
- Acronym
- FEAR-ED
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus on Experienced Anxiety Related to an Emergency Department Visit
- ClinicalTrials.gov ID
- NCT06202729
- Acronym / sponsor ID
- FEAR-ED / MCLSEH1
- Conditions
- Fear
- Keywords
- Fear, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 11 Jan 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients visiting the ED.
Key inclusion criteria (3 listed)
- Age 18 years and older
- Competent to decide on study participation
- Written informed consent obtained
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| QuestionnaireGAD-7, VAS-A, NRS | Other | – |
Primary outcome
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?
4 secondary outcomes
Timing ER visit
Time frame: 1 Day
Start of fear (open question)
Time frame: 1 Day
Influence of pain (NRS) on fear (GAD-7)
Time frame: 1 Day
Cause of fear (open question)
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear, run by Frisius Medisch Centrum at 1 site in Netherlands.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anxiety measured by GAD-7 and VAS-A (time frame: Two weeks prior to ED presentation). 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 13 Mar 2024.