FearNCT05191407
Fear and Anxiety Level in Dental Patients During the COVID-19 Pandemic
An observational study of Fear and Anxiety, run by Zeliha Aytekin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- How many people
- 301 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Sep 2020to 23 Oct 2020
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of individuals randomly selected from the patients who applied to the Faculty of Dentistry.
Who may be able to join
- willing to participate with providing informed consent;
- age ≥18 years
- able to understand and read \& write the Turkish language.
Who cannot join
- not willing to participate with providing informed consent;
- age<18 years
- not able to understand and read \& write the Turkish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Factors Associated With the Increased Fear and Anxiety in Dental Patients During the COVID-19 Pandemic in Turkey: A Survey
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.
Read the detailed description
Officially, the first COVID-19 case in Turkey was diagnosed on March 10, 2020. To ensure social isolation, cities were locked down with residents to stay at home to prevent disease transmission. A very large part of the population may experience frustration, stress, and irritability while in isolation. Due to the prolonged lockdown and COVID-19 associated fear, the COVID-19 pandemic, which threatens people's physical health and lives, is likely to trigger a wide variety of psychological problems such as anxiety and depression by increasing their stress levels.
The risk of cross-infection in dentistry has been described as considerably high due to close physical contact between dental professionals and patients, and aerosols production during routine dental treatments. In this uncertain process, patients remain undecided about attending their dental appointments. Their concern is associated with the risk of getting infected and transmitting the disease to family members. All these factors may increase the mental stress of patients.
The essential purpose of this study is to evaluate the COVID-19 fear and anxiety level, COVID-19 knowledge status, and information sources in dental patients in Turkey during the pandemic period.
- Keywords
- COVID-19 Pandemic, COVID-19, fear, anxiety
- Medical subject headings
- Anxiety Disorders, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
fear of COVID-19
The fear of participants is measured by the Turkish validated version of the fear of COVID-19 Scale.
Measured: 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
Measured: last two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start23 Sep 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeliha Aytekin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeliha Aytekin, Akdeniz University
- Investigators
- Özlem Daltaban, PhD, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191407
- Sponsor's protocol ID
- 70904504 /706
- Status last verified
- Jan 2022
- First submitted
- 28 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 32505461Al-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.
PubMed 33901260
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Associated With the Increased Fear and Anxiety in Dental Patients During the COVID-19 Pandemic in Turkey: A Survey
- ClinicalTrials.gov ID
- NCT05191407
- Acronym / sponsor ID
- 70904504 /706
- Keywords
- COVID-19 Pandemic, COVID-19, fear, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Zeliha AytekinUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 13 Jan 2022 (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.
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.
Detailed description
Officially, the first COVID-19 case in Turkey was diagnosed on March 10, 2020. To ensure social isolation, cities were locked down with residents to stay at home to prevent disease transmission. A very large part of the population may experience frustration, stress, and irritability while in isolation. Due to the prolonged lockdown and COVID-19 associated fear, the COVID-19 pandemic, which threatens people's physical health and lives, is likely to trigger a wide variety of psychological problems such as anxiety and depression by increasing their stress levels.
The risk of cross-infection in dentistry has been described as considerably high due to close physical contact between dental professionals and patients, and aerosols production during routine dental treatments. In this uncertain process, patients remain undecided about attending their dental appointments. Their concern is associated with the risk of getting infected and transmitting the disease to family members. All these factors may increase the mental stress of patients.
The essential purpose of this study is to evaluate the COVID-19 fear and anxiety level, COVID-19 knowledge status, and information sources in dental patients in Turkey during the pandemic period.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of individuals randomly selected from the patients who applied to the Faculty of Dentistry.
Key inclusion criteria (3 listed)
- willing to participate with providing informed consent;
- age ≥18 years
- able to understand and read \& write the Turkish language.
Key exclusion criteria (3 listed)
- not willing to participate with providing informed consent;
- age<18 years
- not able to understand and read \& write the Turkish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fear of COVID-19
Time frame: last six month ( from the beggining of the pandemic to time of survey)
The fear of participants is measured by the Turkish validated version of the fear of COVID-19 Scale.
anxiety
Time frame: last two weeks
The anxiety level of the participants is measured by the Turkish version of Generalized Anxiety Disorder-7 Scale
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 Jan 2022.
- Background: PubMed 32505461Temsah 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.
- Results publication: PubMed 33901260Al-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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Fear
RecruitingObservational study
Lived Experiences of Women Diagnosed With HPV Infection
Human Papillomavirus Infection
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
Chronic Primary Orofacial Pain (CPOP), Persistent Idiopathic Facial Pain (PIFP)
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
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.
Özlem Daltaban, PhD study director
Akdeniz University
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 and Anxiety, run by Zeliha Aytekin 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 3 inclusion and 3 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 Jan 2022. 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?
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?
fear of COVID-19 (time frame: last six month ( from the beggining of the pandemic to time of survey)). The study lists 2 primary outcomes in all. 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 NCT05191407, which also lists 2 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 13 Jan 2022.