Covid19NCT04497818
Correlation Fear of COVID-19 & Dental Treatment Anxiety
An observational study of Covid19 and Fear, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
Purpose: COVID-19 Pandemic has created fears, anxiety and worries among general population. COVID-19 airborne transmission is possible under circumstances in which procedures generate aerosols. Various dental treatment procedures can generate aerosols. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Fear, Dental Anxiety
- What is being tested?
- Cross Sectional study using scientifically validated psychometric Scales
- How many people
- 385 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 16 Jun 2020to 25 Jul 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and Female Human volunteer internet users who belong \&/or reside in Al Qassim province region of Saudi Arabia are the target population for this Cross sectional study. The study population belonged to the major age group. The google form questionnaire soght for the respondents compulsory declaration of age and sound mental status. The google form also sought for the respondents compulsory consent for the survey.
Who may be able to join
- Male and Female Human volunteer internet users who belong \&/or reside in Al Qassim province region of Saudi Arabia.
- Volunteers should be major by age (18 years and above).
- People who took Dental treatment earlier in their lifetime.
- People who may take the Dental treatment in near few days or weeks or months or in a year.
Who cannot join
- Minor age group (<18 years) subjects are excluded from the study.
- Internet users who have preexisting phobia and/or anxiety mental conditions are excluded from the study.
- Internet users who are currently under treatment for their preexisting phobia and/or anxiety mental conditions are excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Fear of COVID-19 Infection and Dental Treatment Anxiety Among Netizens: A Cross-sectional Study.
Purpose:
COVID-19 Pandemic has created fears, anxiety and worries among general population. COVID-19 airborne transmission is possible under circumstances in which procedures generate aerosols. Various dental treatment procedures can generate aerosols. This Cross Sectional Observational study was conducted with the following objectives: 1. Assessment of Fear of COVID-19 among netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. 2. Assessment of Dental Anxiety among netizens in Al Qassim provincen using (MDA) Modified Dental Anxiety 5 item Likert Scale.
Methods: Sample size was (n=385) estimated based on the population size in Al Qassim province (Confidence Interval 95%, Design effect 1 \& hypothesized % frequency of outcome factor of 50%). Assessment of Fear of COVID-19 was estimated using FEAR OF COVID-19, a 5 item Likert Scale. Assessment of Dental Anxiety was estimated using Modified Dental Anxiety 5 item Likert Scale. An online Survey form (Arabic \& English) was developed using Google form application. The Google form link was shared to the netizens of Al Qassim province, across Social media platforms. Statistical analysis is done using SPSS 22.00 software program.
Read the detailed description
COVID-19 Infection was characterized as a Pandemic by WHO on the 11th of March 2020. After this there were all possible worldwide efforts to increase awareness in the general population about the COVID-19 Infection signs, symptoms, mode of transmission and prevention. The information was spread across all possible mass media communication channels.
There were constant updates regarding the data of newly infected cases, deaths, and recoveries. COVID-19 Pandemic has created fears, anxiety, and worries among the general population. COVID-19 spreads from person to person through Droplet transmission within 1-meter distance. COVID-19 airborne transmission is possible under specific circumstances and settings in which procedures or support treatments that generate aerosols. Various dental treatment procedures involve the use of equipment that can generate aerosols. Aerosols contain microorganisms and remain suspended in air in the work environment. This can potentially transfer the infectious microorganisms to the working staff and/or subsequent patients attending the Dental clinics. After the advent of COVID-19 Pandemic, there is a clear paradigm shift in Healthcare services. As the Pandemic transmission is easily transmitted through droplets and aerosols, concern regarding Dental treatment has remained as an issue.
Several past cross-sectional studies have established that Dental seeking behaviour of patients is influenced by Fear and Anxiety to Dental treatment procedures.
As the world faces COVID-19 Pandemic, the Fear of COVID-19 infection and awareness regarding COVID-19 infection can majorly influence the Dental treatment seeking behavior. General population awareness regarding droplet transmission of COVID-19 can potentially influence the fear, worry, and anxiety in Dental treatment seeking patients. The research regarding the correlation of Fear of COVID-19 to Dental treatment Anxiety is very sparse.
The psychological aspects of COVID-19 Fear and Dental anxiety have to be considered and researched.
This online Observational Cross-sectional survey study was conducted among netizens in Al Qassim province of Saudi Arabia with the following objectives:
- To assess Fear of COVID-19 among netizins in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale.
- To assess Dental Anxiety among netizins in Al Qassim province using (MDA) Modified Dental Anxiety 5 item Likert Scale.
- Correlation of Fear of COVID-19 with Dental Anxiety among Netizens in Al Qassim province.
- Association of nearest Dental treatment seeking time and Fear of COVID.
- Association of nearest Dental treatment seeking time and MDA.
- Conditions
- Covid19, Fear, Dental Anxiety
- Being tested
- Cross Sectional study using scientifically validated psychometric Scales
- Keywords
- Fear of COVID-19 scale, COVID-19, Modified Dental anxiety scale, Aerosols, Netizens
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross Sectional study using scientifically validated psychometric ScalesOther
Cross Sectional study using scientifically validated psychometric Scales (FEAR OF COVID-19, a 5 item Likert Scale \& Modified Dental Anxiety 5 item Likert Scale).
| Study group | Role | What they receive |
|---|---|---|
| Netizens | Netizens of Al Qassim province of Saudi Arabia were the target population for this cross sectional study. Sample size is (n=385) estimated based on the population size in Al Qassim province (Confidence Interval 95%, Design effect 1 \& hypothesized % frequency of outcome factor of 50%). Assessment of Fear of COVID-19 was estimated using FEAR OF COVID-19, a 5 item Likert Scale. Assessment of Dental Anxiety was estimated using Modified Dental Anxiety 5 item Likert Scale. An online Survey form (Arabic 7 English) was developed using Google form application. The Google form link was shared to the netizens of Al Qassim province, across all relevant Social media platforms. Statistical analysis is done using SPSS 22.00 software program. Receives: Other: Cross Sectional study using scientifically validated psychometric Scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of COVID-19 infection
Assessed Fear of COVID-19 among netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. Descriptive statistics is used to present the data.
Measured: 5th August 2020
Dental Anxiety
Assessed Dental Anxiety among netizens in Al Qassim province using (MDA) Modified Dental Anxiety 5 item Likert Scale. Descriptive statistics is used to present the data.
Measured: 5th August 2020
Correlation of Fear of COVID-19 infection & Dental Anxiety
The survey data is statistically analyzed to check for the correlation of the Fear of COVID-19 with Dental Anxiety among Netizens in Qassim region. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.
Measured: 5th August 2020
Secondary outcomes (4)
Correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection.
The survey data is statistically analyzed to check for the correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.
Measured: 5th August 2020
Correlation of the nearest Dental treatment seeking time and Dental Anxiety
The survey data is statistically analyzed to check for the correlation of the nearest Dental treatment seeking time and Dental Anxiety. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.
Measured: 5th August 2020
Correlation of the Age and Fear of COVID-19 infection
The survey data is statistically analyzed to check for the correlation of Age and Fear of COVID-19 infection The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 will be considered statistically significant correlation of the variables analysed.
Measured: 5th August 2020
Correlation of the Age and Dental Anxiety.
The survey data is statistically analyzed to check for the correlation of the Age and Dental Anxiety. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.
Measured: 5th August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start16 Jun 2020
- Primary completion16 Jul 2020
- Study completion25 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Shiva Shankar Bugude, Qassim University
- Investigators
- Bugude Shiva Shankar, Principal investigator, College of Applied Health Sciences - Al Rass
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497818
- Sponsor's protocol ID
- QassimU2
- Status last verified
- Aug 2020
- First submitted
- 1 Aug 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Research data will be available to the Principal Investigator. On requirement the data will be shared to whomsoever after consultation with the concerned higher authorities in the College of Applied Health sciences in Ar rass. The descriptive \& analytical data will be used for scientific publication.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Fear of COVID-19 Infection and Dental Treatment Anxiety Among Netizens: A Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT04497818
- Acronym / sponsor ID
- QassimU2
- Conditions
- Covid19, Fear, Dental Anxiety
- Keywords
- Fear of COVID-19 scale, COVID-19, Modified Dental anxiety scale, Aerosols, Netizens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 4 Aug 2020 (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.
Purpose:
COVID-19 Pandemic has created fears, anxiety and worries among general population. COVID-19 airborne transmission is possible under circumstances in which procedures generate aerosols. Various dental treatment procedures can generate aerosols. This Cross Sectional Observational study was conducted with the following objectives: 1. Assessment of Fear of COVID-19 among netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. 2. Assessment of Dental Anxiety among netizens in Al Qassim provincen using (MDA) Modified Dental Anxiety 5 item Likert Scale.
Methods: Sample size was (n=385) estimated based on the population size in Al Qassim province (Confidence Interval 95%, Design effect 1 \& hypothesized % frequency of outcome factor of 50%). Assessment of Fear of COVID-19 was estimated using FEAR OF COVID-19, a 5 item Likert Scale. Assessment of Dental Anxiety was estimated using Modified Dental Anxiety 5 item Likert Scale. An online Survey form (Arabic \& English) was developed using Google form application. The Google form link was shared to the netizens of Al Qassim province, across Social media platforms. Statistical analysis is done using SPSS 22.00 software program.
Detailed description
COVID-19 Infection was characterized as a Pandemic by WHO on the 11th of March 2020. After this there were all possible worldwide efforts to increase awareness in the general population about the COVID-19 Infection signs, symptoms, mode of transmission and prevention. The information was spread across all possible mass media communication channels.
There were constant updates regarding the data of newly infected cases, deaths, and recoveries. COVID-19 Pandemic has created fears, anxiety, and worries among the general population. COVID-19 spreads from person to person through Droplet transmission within 1-meter distance. COVID-19 airborne transmission is possible under specific circumstances and settings in which procedures or support treatments that generate aerosols. Various dental treatment procedures involve the use of equipment that can generate aerosols. Aerosols contain microorganisms and remain suspended in air in the work environment. This can potentially transfer the infectious microorganisms to the working staff and/or subsequent patients attending the Dental clinics. After the advent of COVID-19 Pandemic, there is a clear paradigm shift in Healthcare services. As the Pandemic transmission is easily transmitted through droplets and aerosols, concern regarding Dental treatment has remained as an issue.
Several past cross-sectional studies have established that Dental seeking behaviour of patients is influenced by Fear and Anxiety to Dental treatment procedures.
As the world faces COVID-19 Pandemic, the Fear of COVID-19 infection and awareness regarding COVID-19 infection can majorly influence the Dental treatment seeking behavior. General population awareness regarding droplet transmission of COVID-19 can potentially influence the fear, worry, and anxiety in Dental treatment seeking patients. The research regarding the correlation of Fear of COVID-19 to Dental treatment Anxiety is very sparse.
The psychological aspects of COVID-19 Fear and Dental anxiety have to be considered and researched.
This online Observational Cross-sectional survey study was conducted among netizens in Al Qassim province of Saudi Arabia with the following objectives:
- To assess Fear of COVID-19 among netizins in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale.
- To assess Dental Anxiety among netizins in Al Qassim province using (MDA) Modified Dental Anxiety 5 item Likert Scale.
- Correlation of Fear of COVID-19 with Dental Anxiety among Netizens in Al Qassim province.
- Association of nearest Dental treatment seeking time and Fear of COVID.
- Association of nearest Dental treatment seeking time and MDA.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Netizens | – | Other: Cross Sectional study using scientifically validated psychometric ScalesNetizens of Al Qassim province of Saudi Arabia were the target population for this cross sectional study. Sample size is (n=385) estimated based on the population size in Al Qassim province (Confidence Interval 95%, Design effect 1 \& hypothesized % frequency of outcome factor of 50%). Assessment of Fear of COVID-19 was estimated using FEAR OF COVID-19, a 5 item Likert Scale. Assessment of Dental Anxiety was estimated using Modified Dental Anxiety 5 item Likert Scale. An online Survey form (Arabic 7 English) was developed using Google form application. The Google form link was shared to the netizens of Al Qassim province, across all relevant Social media platforms. Statistical analysis is done using SPSS 22.00 software program. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and Female Human volunteer internet users who belong \&/or reside in Al Qassim province region of Saudi Arabia are the target population for this Cross sectional study. The study population belonged to the major age group. The google form questionnaire soght for the respondents compulsory declaration of age and sound mental status. The google form also sought for the respondents compulsory consent for the survey.
Key inclusion criteria (4 listed)
- Male and Female Human volunteer internet users who belong \&/or reside in Al Qassim province region of Saudi Arabia.
- Volunteers should be major by age (18 years and above).
- People who took Dental treatment earlier in their lifetime.
- People who may take the Dental treatment in near few days or weeks or months or in a year.
Key exclusion criteria (3 listed)
- Minor age group (<18 years) subjects are excluded from the study.
- Internet users who have preexisting phobia and/or anxiety mental conditions are excluded from the study.
- Internet users who are currently under treatment for their preexisting phobia and/or anxiety mental conditions are excluded from the study.
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 |
|---|---|---|
| Cross Sectional study using scientifically validated psychometric ScalesCross Sectional study using scientifically validated psychometric Scales (FEAR OF COVID-19, a 5 item Likert Scale \& Modified Dental Anxiety 5 item Likert Scale). | Other | Netizens |
Primary outcome
Fear of COVID-19 infection
Time frame: 5th August 2020
Assessed Fear of COVID-19 among netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. Descriptive statistics is used to present the data.
Dental Anxiety
Time frame: 5th August 2020
Assessed Dental Anxiety among netizens in Al Qassim province using (MDA) Modified Dental Anxiety 5 item Likert Scale. Descriptive statistics is used to present the data.
Correlation of Fear of COVID-19 infection & Dental Anxiety
Time frame: 5th August 2020
The survey data is statistically analyzed to check for the correlation of the Fear of COVID-19 with Dental Anxiety among Netizens in Qassim region. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.
4 secondary outcomes
Correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection.
Time frame: 5th August 2020
Correlation of the nearest Dental treatment seeking time and Dental Anxiety
Time frame: 5th August 2020
Correlation of the Age and Fear of COVID-19 infection
Time frame: 5th August 2020
Correlation of the Age and Dental Anxiety.
Time frame: 5th August 2020
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 4 Aug 2020.
- Individual participant dataSharing planned: Undecided. The Research data will be available to the Principal Investigator. On requirement the data will be shared to whomsoever after consultation with the concerned higher authorities in the College of Applied Health sciences in Ar rass. The descriptive \& analytical data will be used for scientific publication.
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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.
Bugude Shiva Shankar principal investigator
College of Applied Health Sciences - Al Rass
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 Covid19 and Fear, run by Qassim University at 1 site in Saudi Arabia.
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 4 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 4 Aug 2020. 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 Saudi Arabia. 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 infection (time frame: 5th August 2020). The study lists 3 primary outcomes in all. 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 4 Aug 2020.