COVID-19 PandemicNCT04674644
Analysing the Psychosocial Effects of COVID-19 Pandemic on Dental Professionals Using the Turkish Version of the Fear of COVID-19 and Coronavirus Anxiety Scales
A study testing The psychosocial effects of COVID-19 pandemic on dental professionals in people with COVID-19 Pandemic, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The aims of this study were to (i) assess fear and anxiety of COVID-19 in a Turkish sample dental professionals using the Turkish FCV-19S and CAS; (ii) explore factors associated with FCV-19S and CAS; and (iii) examine the psychometric properties of the Turkish FCV-19S and CAS. Read more about this study
- Who is it for?
- Ages 23 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- The psychosocial effects of COVID-19 pandemic on dental professionals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2020to 23 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 23 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dental professionals working in public hospitals
- Dental professionals working in university hospitals
Who cannot join
- Dental professionals working in private clinics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
Isparta, 32260
About this study
Official title: Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
The aims of this study were to (i) assess fear and anxiety of COVID-19 in a Turkish sample dental professionals using the Turkish FCV-19S and CAS; (ii) explore factors associated with FCV-19S and CAS; and (iii) examine the psychometric properties of the Turkish FCV-19S and CAS.
Read the detailed description
This cross-sectional study was conducted between October, 16 to 23, 2020 by sending an online survey questionnaire working in public and university hospitals, including general dentists or specialists. The tool utilized for data collection was a designed online Google Forms questionnaire.
This survey was implemented by using a questionnaire that included socio-demographic data (age range, gender, marital status, systemic disease, professional area, years of clinical experience, number of patients treated daily, smoking status, alcohol consumption, vs), epidemic-related questions and scales measuring the fear and anxiety levels of the participants.
Fear of COVID-19 Scale is an unidimensional scale seven-item scale assessing anxiety regarding COVID-19 developed by Ahorsu et al. Items are rated on a 5-item Likert scale from 1 (Strongly disagree) to 5 (Strongly agree) with scores ranging from 7 to 35. A higher score of the FCV-19S represents a greater level of fear. In the study, the bi-factor model and two-factor model consisting of the "emotional response" factor (items 1, 2, 4, and 5) and "physiological response" factor (items 3, 6, and 7) were used.
Coronavirus Anxiety Scale is an unidimensional tool that assesses the physiological reactions anxiety related to the COVID-19 pandemic. Participants were asked to rate 5 items on a 5-point Likert-type scale, from 0 (not at all) to 4 (nearly every day over the last 2 weeks).
- Conditions
- COVID-19 Pandemic
- Being tested
- The psychosocial effects of COVID-19 pandemic on dental professionals
- Keywords
- Fear of COVID-19, Coronavirus anxiety scale, COVID-19, dental professionals, psychosocial effects
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The psychosocial effects of COVID-19 pandemic on dental professionalsBehavioural
Analysing the psychosocial effects of COVID-19 pandemic on dental professionals using the Turkish version of the Fear of COVID-19 and Coronavirus Anxiety Scales
| Study group | Role | What they receive |
|---|---|---|
| Analysing the psychosocial effects of COVID-19 pandemic on dental professionals | Other | Dental professionals Receives: Behavioral: The psychosocial effects of COVID-19 pandemic on dental professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Psychosocial Effects of COVID-19 Pandemic on Dental Professionals Using the Turkish Version of the Fear of COVID-19 Scale
Fear of COVID-19 Scale is an unidimensional scale seven-item scale assessing anxiety regarding COVID-19 . Items are rated on a 5-item Likert scale from 1 (Strongly disagree) to 5 (Strongly agree) with scores ranging from 7 to 35. Scores are added up. A higher score of the FCV-19S represents a greater level of fear and a worse outcome.
Measured: during the survey administration
Secondary outcomes (1)
The Psychosocial Effects of COVID-19 Pandemic Using the Turkish Version of the Coronavirus Anxiety Scale
Coronavirus Anxiety Scale is an unidimensional tool that assesses the physiological anxiety related to the COVID-19. Participants rated 5 items on a 5-point Likert-type scale, from 0 (not at all) to 4 (nearly every day over the last 2 weeks). Scores are added up for a total score of 0 - 20, with higher scores indicating worse outcomes.
Measured: during the survey administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start16 Oct 2020
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dental professionals
- Masking
- None (open label)
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Oz, Suleyman Demirel University
- Investigators
- esra Oz, Assist Prof, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674644
- Sponsor's protocol ID
- 355
- Status last verified
- Jan 2021
- First submitted
- 16 Dec 2020
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahmood QK, Jafree SR, Qureshi WA. The Psychometric Validation of FCV19S in Urdu and Socio-Demographic Association with Fear in the People of the Khyber Pakhtunkhwa (KPK) Province in Pakistan. Int J Ment Health Addict. 2022;20(1):426-436. doi: 10.1007/s11469-020-00371-4. Epub 2020 Jul 12.
PubMed 32837443Ahmed O, Faisal RA, Sharker T, Lee SA, Jobe MC. Adaptation of the Bangla Version of the COVID-19 Anxiety Scale. Int J Ment Health Addict. 2022;20(1):284-295. doi: 10.1007/s11469-020-00357-2. Epub 2020 Jun 27.
PubMed 32837436Alyami M, Henning M, Krageloh CU, Alyami H. Psychometric Evaluation of the Arabic Version of the Fear of COVID-19 Scale. Int J Ment Health Addict. 2021;19(6):2219-2232. doi: 10.1007/s11469-020-00316-x. Epub 2020 May 16.
PubMed 32427217Andrade EF, Pereira LJ, Oliveira APL, Orlando DR, Alves DAG, Guilarducci JS, Castelo PM. Perceived fear of COVID-19 infection according to sex, age and occupational risk using the Brazilian version of the Fear of COVID-19 Scale. Death Stud. 2022;46(3):533-542. doi: 10.1080/07481187.2020.1809786. Epub 2020 Aug 26.
PubMed 32845795
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
- ClinicalTrials.gov ID
- NCT04674644
- Acronym / sponsor ID
- 355
- Conditions
- COVID-19 Pandemic
- Keywords
- Fear of COVID-19, Coronavirus anxiety scale, COVID-19, dental professionals, psychosocial effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Posted 29 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study were to (i) assess fear and anxiety of COVID-19 in a Turkish sample dental professionals using the Turkish FCV-19S and CAS; (ii) explore factors associated with FCV-19S and CAS; and (iii) examine the psychometric properties of the Turkish FCV-19S and CAS.
Detailed description
This cross-sectional study was conducted between October, 16 to 23, 2020 by sending an online survey questionnaire working in public and university hospitals, including general dentists or specialists. The tool utilized for data collection was a designed online Google Forms questionnaire.
This survey was implemented by using a questionnaire that included socio-demographic data (age range, gender, marital status, systemic disease, professional area, years of clinical experience, number of patients treated daily, smoking status, alcohol consumption, vs), epidemic-related questions and scales measuring the fear and anxiety levels of the participants.
Fear of COVID-19 Scale is an unidimensional scale seven-item scale assessing anxiety regarding COVID-19 developed by Ahorsu et al. Items are rated on a 5-item Likert scale from 1 (Strongly disagree) to 5 (Strongly agree) with scores ranging from 7 to 35. A higher score of the FCV-19S represents a greater level of fear. In the study, the bi-factor model and two-factor model consisting of the "emotional response" factor (items 1, 2, 4, and 5) and "physiological response" factor (items 3, 6, and 7) were used.
Coronavirus Anxiety Scale is an unidimensional tool that assesses the physiological reactions anxiety related to the COVID-19 pandemic. Participants were asked to rate 5 items on a 5-point Likert-type scale, from 0 (not at all) to 4 (nearly every day over the last 2 weeks).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dental professionals
| Arm | Type | Receives |
|---|---|---|
| Analysing the psychosocial effects of COVID-19 pandemic on dental professionals | Other | Behavioral: The psychosocial effects of COVID-19 pandemic on dental professionalsDental professionals |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dental professionals working in public hospitals
- Dental professionals working in university hospitals
Key exclusion criteria (1 listed)
- Dental professionals working in private clinics
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 |
|---|---|---|
| The psychosocial effects of COVID-19 pandemic on dental professionalsAnalysing the psychosocial effects of COVID-19 pandemic on dental professionals using the Turkish version of the Fear of COVID-19 and Coronavirus Anxiety Scales | Behavioural | Analysing the psychosocial effects of COVID-19 pandemic on dental professionals |
Primary outcome
The Psychosocial Effects of COVID-19 Pandemic on Dental Professionals Using the Turkish Version of the Fear of COVID-19 Scale
Time frame: during the survey administration
Fear of COVID-19 Scale is an unidimensional scale seven-item scale assessing anxiety regarding COVID-19 . Items are rated on a 5-item Likert scale from 1 (Strongly disagree) to 5 (Strongly agree) with scores ranging from 7 to 35. Scores are added up. A higher score of the FCV-19S represents a greater level of fear and a worse outcome.
1 secondary outcome
The Psychosocial Effects of COVID-19 Pandemic Using the Turkish Version of the Coronavirus Anxiety Scale
Time frame: during the survey administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32837443Mahmood QK, Jafree SR, Qureshi WA. The Psychometric Validation of FCV19S in Urdu and Socio-Demographic Association with Fear in the People of the Khyber Pakhtunkhwa (KPK) Province in Pakistan. Int J Ment Health Addict. 2022;20(1):426-436. doi: 10.1007/s11469-020-00371-4. Epub 2020 Jul 12.
- Background: PubMed 32837436Ahmed O, Faisal RA, Sharker T, Lee SA, Jobe MC. Adaptation of the Bangla Version of the COVID-19 Anxiety Scale. Int J Ment Health Addict. 2022;20(1):284-295. doi: 10.1007/s11469-020-00357-2. Epub 2020 Jun 27.
- Background: PubMed 32427217Alyami M, Henning M, Krageloh CU, Alyami H. Psychometric Evaluation of the Arabic Version of the Fear of COVID-19 Scale. Int J Ment Health Addict. 2021;19(6):2219-2232. doi: 10.1007/s11469-020-00316-x. Epub 2020 May 16.
- Background: PubMed 32845795Andrade EF, Pereira LJ, Oliveira APL, Orlando DR, Alves DAG, Guilarducci JS, Castelo PM. Perceived fear of COVID-19 infection according to sex, age and occupational risk using the Brazilian version of the Fear of COVID-19 Scale. Death Stud. 2022;46(3):533-542. doi: 10.1080/07481187.2020.1809786. Epub 2020 Aug 26.
- 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.
esra Oz, Assist Prof principal investigator
Suleyman Demirel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The psychosocial effects of COVID-19 pandemic on dental professionals in people with COVID-19 Pandemic, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 2 Feb 2021. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Psychosocial Effects of COVID-19 Pandemic on Dental Professionals Using the Turkish Version of the Fear of COVID-19 Scale (time frame: during the survey administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04674644, which also lists 4 linked publications.
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 2 Feb 2021.