NCT06202729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

December 15, 2023

Last Update Submit

March 12, 2024

Conditions

Fear

Keywords

Fear, anxiety

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • Timing ER visit

    1 Day

  • Start of fear (open question)

    1 Day

  • Influence of pain (NRS) on fear (GAD-7)

    1 Day

  • Cause of fear (open question)

    1 Day

Interventions

QuestionnaireOTHER

GAD-7, VAS-A, NRS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients visiting the ED.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MCLeeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2023

First Posted

January 11, 2024

Study Start

November 8, 2023

Primary Completion

December 11, 2023

Study Completion

December 11, 2023

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)