NCT04497818

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 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

June 16, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

August 1, 2020

Last Update Submit

August 1, 2020

Conditions

Keywords

Fear of COVID-19 scaleCOVID-19Modified Dental anxiety scaleAerosolsNetizens

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    5th August 2020

Secondary Outcomes (4)

  • Correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection.

    5th August 2020

  • Correlation of the nearest Dental treatment seeking time and Dental Anxiety

    5th August 2020

  • Correlation of the Age and Fear of COVID-19 infection

    5th August 2020

  • Correlation of the Age and Dental Anxiety.

    5th August 2020

Study Arms (1)

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.

Other: Cross Sectional study using scientifically validated psychometric Scales

Interventions

Cross Sectional study using scientifically validated psychometric Scales (FEAR OF COVID-19, a 5 item Likert Scale \& Modified Dental Anxiety 5 item Likert Scale).

Netizens

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Bugude Shiva Shankar

Ar Rass, Al Qassim, 51921, Saudi Arabia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bugude Shiva Shankar

    College of Applied Health Sciences - Al Rass

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 1, 2020

First Posted

August 4, 2020

Study Start

June 16, 2020

Primary Completion

July 16, 2020

Study Completion

July 25, 2020

Last Updated

August 4, 2020

Record last verified: 2020-08

Locations