NCT05191407

Brief Summary

Psychological support may be needed to help patients in the face of emotional disturbances that may be associated with the outbreak and to help them accomplish their fear and anxiety. Due to the increasing fear of COVID-19 transmission during the pandemic, patients may develop treatment avoidance behavior in dental practices. If the fear and anxiety levels of the patients can be determined, it may be easy to offer special approaches to them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

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

September 23, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

1 month

First QC Date

December 28, 2021

Last Update Submit

January 12, 2022

Conditions

Keywords

COVID-19 PandemicCOVID-19fearanxiety

Outcome Measures

Primary Outcomes (2)

  • fear of COVID-19

    The fear of participants is measured by the Turkish validated version of the fear of COVID-19 Scale.

    last six month ( from the beggining of the pandemic to time of survey)

  • anxiety

    The anxiety level of the participants is measured by the Turkish version of Generalized Anxiety Disorder-7 Scale

    last two weeks

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of individuals randomly selected from the patients who applied to the Faculty of Dentistry.

You may qualify if:

  • willing to participate with providing informed consent;
  • age ≥18 years
  • able to understand and read \& write the Turkish language.

You may not qualify if:

  • not willing to participate with providing informed consent;
  • age\<18 years
  • not able to understand and read \& write the Turkish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07058, Turkey (Türkiye)

Location

Related Publications (2)

  • Temsah MH, Al-Sohime F, Alamro N, Al-Eyadhy A, Al-Hasan K, Jamal A, Al-Maglouth I, Aljamaan F, Al Amri M, Barry M, Al-Subaie S, Somily AM. The psychological impact of COVID-19 pandemic on health care workers in a MERS-CoV endemic country. J Infect Public Health. 2020 Jun;13(6):877-882. doi: 10.1016/j.jiph.2020.05.021. Epub 2020 May 29.

    PMID: 32505461BACKGROUND
  • Al-Rahimi JS, Nass NM, Hassoubah SA, Wazqar DY, Alamoudi SA. Levels and predictors of fear and health anxiety during the current outbreak of COVID-19 in immunocompromised and chronic disease patients in Saudi Arabia: A cross-sectional correlational study. PLoS One. 2021 Apr 26;16(4):e0250554. doi: 10.1371/journal.pone.0250554. eCollection 2021.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological samples were not taken from individuals in the study. The study is a survey study.

MeSH Terms

Conditions

Anxiety DisordersCOVID-19

Condition Hierarchy (Ancestors)

Mental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Özlem Daltaban, PhD

    Akdeniz University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 13, 2022

Study Start

September 23, 2020

Primary Completion

October 23, 2020

Study Completion

October 23, 2020

Last Updated

January 13, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations