<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04497818</url>
  </required_header>
  <id_info>
    <org_study_id>QassimU2</org_study_id>
    <nct_id>NCT04497818</nct_id>
  </id_info>
  <brief_title>Correlation Fear of COVID-19 &amp; Dental Treatment Anxiety</brief_title>
  <official_title>Correlation of Fear of COVID-19 Infection and Dental Treatment Anxiety Among Netizens: A Cross-sectional Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qassim University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qassim University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose:&#xD;
&#xD;
      COVID-19 Pandemic has created fears, anxiety and worries among general population. COVID-19&#xD;
      airborne transmission is possible under circumstances in which procedures generate aerosols.&#xD;
      Various dental treatment procedures can generate aerosols. This Cross Sectional Observational&#xD;
      study was conducted with the following objectives: 1. Assessment of Fear of COVID-19 among&#xD;
      netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. 2. Assessment&#xD;
      of Dental Anxiety among netizens in Al Qassim provincen using (MDA) Modified Dental Anxiety 5&#xD;
      item Likert Scale.&#xD;
&#xD;
      Methods: Sample size was (n=385) estimated based on the population size in Al Qassim province&#xD;
      (Confidence Interval 95%, Design effect 1 &amp; hypothesized % frequency of outcome factor of&#xD;
      50%). Assessment of Fear of COVID-19 was estimated using FEAR OF COVID-19, a 5 item Likert&#xD;
      Scale. Assessment of Dental Anxiety was estimated using Modified Dental Anxiety 5 item Likert&#xD;
      Scale. An online Survey form (Arabic &amp; English) was developed using Google form application.&#xD;
      The Google form link was shared to the netizens of Al Qassim province, across Social media&#xD;
      platforms. Statistical analysis is done using SPSS 22.00 software program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 Infection was characterized as a Pandemic by WHO on the 11th of March 2020. After&#xD;
      this there were all possible worldwide efforts to increase awareness in the general&#xD;
      population about the COVID-19 Infection signs, symptoms, mode of transmission and prevention.&#xD;
      The information was spread across all possible mass media communication channels.&#xD;
&#xD;
      There were constant updates regarding the data of newly infected cases, deaths, and&#xD;
      recoveries. COVID-19 Pandemic has created fears, anxiety, and worries among the general&#xD;
      population. COVID-19 spreads from person to person through Droplet transmission within&#xD;
      1-meter distance. COVID-19 airborne transmission is possible under specific circumstances and&#xD;
      settings in which procedures or support treatments that generate aerosols. Various dental&#xD;
      treatment procedures involve the use of equipment that can generate aerosols. Aerosols&#xD;
      contain microorganisms and remain suspended in air in the work environment. This can&#xD;
      potentially transfer the infectious microorganisms to the working staff and/or subsequent&#xD;
      patients attending the Dental clinics. After the advent of COVID-19 Pandemic, there is a&#xD;
      clear paradigm shift in Healthcare services. As the Pandemic transmission is easily&#xD;
      transmitted through droplets and aerosols, concern regarding Dental treatment has remained as&#xD;
      an issue.&#xD;
&#xD;
      Several past cross-sectional studies have established that Dental seeking behaviour of&#xD;
      patients is influenced by Fear and Anxiety to Dental treatment procedures.&#xD;
&#xD;
      As the world faces COVID-19 Pandemic, the Fear of COVID-19 infection and awareness regarding&#xD;
      COVID-19 infection can majorly influence the Dental treatment seeking behavior. General&#xD;
      population awareness regarding droplet transmission of COVID-19 can potentially influence the&#xD;
      fear, worry, and anxiety in Dental treatment seeking patients. The research regarding the&#xD;
      correlation of Fear of COVID-19 to Dental treatment Anxiety is very sparse.&#xD;
&#xD;
      The psychological aspects of COVID-19 Fear and Dental anxiety have to be considered and&#xD;
      researched.&#xD;
&#xD;
      This online Observational Cross-sectional survey study was conducted among netizens in Al&#xD;
      Qassim province of Saudi Arabia with the following objectives:&#xD;
&#xD;
        1. To assess Fear of COVID-19 among netizins in Al Qassim province using FEAR OF COVID-19,&#xD;
           a 5 item Likert Scale.&#xD;
&#xD;
        2. To assess Dental Anxiety among netizins in Al Qassim province using (MDA) Modified&#xD;
           Dental Anxiety 5 item Likert Scale.&#xD;
&#xD;
        3. Correlation of Fear of COVID-19 with Dental Anxiety among Netizens in Al Qassim&#xD;
           province.&#xD;
&#xD;
        4. Association of nearest Dental treatment seeking time and Fear of COVID.&#xD;
&#xD;
        5. Association of nearest Dental treatment seeking time and MDA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">July 25, 2020</completion_date>
  <primary_completion_date type="Actual">July 16, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fear of COVID-19 infection</measure>
    <time_frame>5th August 2020</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dental Anxiety</measure>
    <time_frame>5th August 2020</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of Fear of COVID-19 infection &amp; Dental Anxiety</measure>
    <time_frame>5th August 2020</time_frame>
    <description>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 &lt;0.05 is considered statistically significant correlation of the variables analysed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection.</measure>
    <time_frame>5th August 2020</time_frame>
    <description>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 &lt;0.05 is considered statistically significant correlation of the variables analysed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the nearest Dental treatment seeking time and Dental Anxiety</measure>
    <time_frame>5th August 2020</time_frame>
    <description>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 &lt;0.05 is considered statistically significant correlation of the variables analysed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the Age and Fear of COVID-19 infection</measure>
    <time_frame>5th August 2020</time_frame>
    <description>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 &lt;0.05 will be considered statistically significant correlation of the variables analysed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the Age and Dental Anxiety.</measure>
    <time_frame>5th August 2020</time_frame>
    <description>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 &lt;0.05 is considered statistically significant correlation of the variables analysed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">385</enrollment>
  <condition>Covid19</condition>
  <condition>Fear</condition>
  <condition>Dental Anxiety</condition>
  <arm_group>
    <arm_group_label>Netizens</arm_group_label>
    <description>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 &amp; 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cross Sectional study using scientifically validated psychometric Scales</intervention_name>
    <description>Cross Sectional study using scientifically validated psychometric Scales (FEAR OF COVID-19, a 5 item Likert Scale &amp; Modified Dental Anxiety 5 item Likert Scale).</description>
    <arm_group_label>Netizens</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and Female Human volunteer internet users who belong &amp;/or reside in Al Qassim province&#xD;
        region of Saudi Arabia are the target population for this Cross sectional study. The study&#xD;
        population belonged to the major age group. The google form questionnaire soght for the&#xD;
        respondents compulsory declaration of age and sound mental status. The google form also&#xD;
        sought for the respondents compulsory consent for the survey.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and Female Human volunteer internet users who belong &amp;/or reside in Al Qassim&#xD;
             province region of Saudi Arabia.&#xD;
&#xD;
          -  Volunteers should be major by age (18 years and above).&#xD;
&#xD;
          -  People who took Dental treatment earlier in their lifetime.&#xD;
&#xD;
          -  People who may take the Dental treatment in near few days or weeks or months or in a&#xD;
             year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor age group (&lt;18 years) subjects are excluded from the study.&#xD;
&#xD;
          -  Internet users who have preexisting phobia and/or anxiety mental conditions are&#xD;
             excluded from the study.&#xD;
&#xD;
          -  Internet users who are currently under treatment for their preexisting phobia and/or&#xD;
             anxiety mental conditions are excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bugude Shiva Shankar</last_name>
    <role>Principal Investigator</role>
    <affiliation>College of Applied Health Sciences - Al Rass</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr Bugude Shiva Shankar</name>
      <address>
        <city>Ar Rass</city>
        <state>Al Qassim</state>
        <zip>51921</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Qassim University</investigator_affiliation>
    <investigator_full_name>Dr Shiva Shankar Bugude</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Fear of COVID-19 scale</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Modified Dental anxiety scale</keyword>
  <keyword>Aerosols</keyword>
  <keyword>Netizens</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>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 &amp; analytical data will be used for scientific publication.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>August 9, 2020</submitted>
    <returned>August 21, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04497818
org study id: QassimU2
nct id: NCT04497818
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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:

        1. To assess Fear of COVID-19 among netizins in Al Qassim province using FEAR OF COVID-19,
           a 5 item Likert Scale.

        2. To assess Dental Anxiety among netizins in Al Qassim province using (MDA) Modified
           Dental Anxiety 5 item Likert Scale.

        3. Correlation of Fear of COVID-19 with Dental Anxiety among Netizens in Al Qassim
           province.

        4. Association of nearest Dental treatment seeking time and Fear of COVID.

        5. Association of nearest Dental treatment seeking time and MDA.
observational model: Other
time perspective: Prospective
measure: Fear of COVID-19 infection
time frame: 5th August 2020
description: 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.
measure: Dental Anxiety
time frame: 5th August 2020
description: 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.
measure: Correlation of Fear of COVID-19 infection & Dental Anxiety
time frame: 5th August 2020
description: 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.
measure: Correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection.
time frame: 5th August 2020
description: 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.
measure: Correlation of the nearest Dental treatment seeking time and Dental Anxiety
time frame: 5th August 2020
description: 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.
measure: Correlation of the Age and Fear of COVID-19 infection
time frame: 5th August 2020
description: 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.
measure: Correlation of the Age and Dental Anxiety.
time frame: 5th August 2020
description: 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.
arm group label: Netizens
description: 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.
intervention type: Other
intervention name: Cross Sectional study using scientifically validated psychometric Scales
description: Cross Sectional study using scientifically validated psychometric Scales (FEAR OF COVID-19, a 5 item Likert Scale & Modified Dental Anxiety 5 item Likert Scale).
arm group label: Netizens
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bugude Shiva Shankar
role: Principal Investigator
affiliation: College of Applied Health Sciences - Al Rass
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Qassim University
investigator full name: Dr Shiva Shankar Bugude
investigator title: Assistant Professor
mesh term: COVID-19
mesh term: Anxiety Disorders
sharing ipd: Undecided
ipd description: 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.
submitted: August 9, 2020
returned: August 21, 2020