AnxietyNCT04460469
Anxiety Level and Oral Hygiene Practice in Dental Students During Covid-19 Pandemic
An observational study of Anxiety and Covid19, run by Cairo University at 1 site in Egypt.
Trial summary
Covid-19, the infection caused by a novel corona virus detected in December 2019 in Wuhan (Hubei province), is now a pandemic announced by World Health Organization, raising concerns of widespread panic and increasing anxiety in individuals. This outbreak results in mass quarantine in Egypt since middle of March 2020. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Covid19, Oral Hygiene
- How many people
- 1,500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The questionnaire is going to be disseminated as google form to all the Cairo university dental students via emails .
Who may be able to join
- Student of faculty of Dentistry, Cairo University
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-assessment of Anxiety Level and Oral Hygiene Practice in Dental Students of Cairo University During Covid-19 Pandemic
Covid-19, the infection caused by a novel corona virus detected in December 2019 in Wuhan (Hubei province), is now a pandemic announced by World Health Organization, raising concerns of widespread panic and increasing anxiety in individuals. This outbreak results in mass quarantine in Egypt since middle of March 2020. Brooks et al. (2019) reviewed and reported quarantine could bring "post traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma.". Many universities decided to suspend in-person classes and evacuate students in responding to the intensifying concerns surrounding Covid-19. This action can lead to negative psychological consequences among college students. Oral health related behavior and attitudes habits correlate with oral health status and can be considered to be its predictors . There is a claim of potential connection between high bacterial load in the mouth and complications associated with Covid-19 infection. Bacteria present in the meta genome of patients severely infected with Covid-19 included high reads for Prevotella, Staphylococcus, and Fusobacterium, all usually commensal organisms of the mouth. Over 80% of patients in ICU exhibited an exceptionally high bacterial load. Accordingly, the investigators assume that good oral hygiene better to be maintained during a Covid-19 outbreak in order to reduce the bacterial load in the mouth and the risk of a bacterial super infection in case of catching the infection .
While there seems to be a common belief that psychosocial stress affects oral hygiene behavior, this assumption has rarely been proved9 Dental students, as the future providers of dental care, are ex¬pected to be role models for their patients regarding the oral hygiene practice and they supposed to be aware of the importance of preserving the oral health. Thus, we intended to select them as our population to study how the level of anxiety during pandemic could affect the practice of oral hygien
Read the detailed description
A cross sectional study (survey) will be conducted among dental students in faculty of dentistry Cairo University for the duration of one month from June 2020 to July 2020.
The questionnaire has three parts. The first part included demographic details. The second part included validated general anxiety disorder scale GAD-7. Questionnaire consisting of seven questions which measures students' anxiety level score. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The third part the validated self administered, structured, and close ended 15 questions that assessed the self reported oral hygiene practices 11. The questionnaire forms were kept anonymous. The questionnaire was validated.
- Conditions
- Anxiety, Covid19, Oral Hygiene
- Keywords
- Anxiety, Covid19, Oral Hygiene Practice, Dental students, questionnaire
- Medical subject headings
- Anxiety Disorders, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
correlate between the level of anxiety and the practice of oral hygiene during covid-19 pandemic in dental students of Cairo university
By questionnaire
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jul 2020
- Primary completion1 Sep 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Zakaria Ibrahium Mohammed, Cairo University
- Investigators
- Mai Zakaria, Ph, Principal investigator, Lecturer Oral Medicine & Periodontology, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460469
- Sponsor's protocol ID
- Mai Zakaria 4
- Status last verified
- Mar 2022
- First submitted
- 4 Jul 2020
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data are not to be shared with other researchers until publication of the study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-assessment of Anxiety Level and Oral Hygiene Practice in Dental Students of Cairo University During Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04460469
- Acronym / sponsor ID
- Mai Zakaria 4
- Conditions
- Anxiety, Covid19, Oral Hygiene
- Keywords
- Anxiety, Covid19, Oral Hygiene Practice, Dental students, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 7 Jul 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.
Covid-19, the infection caused by a novel corona virus detected in December 2019 in Wuhan (Hubei province), is now a pandemic announced by World Health Organization, raising concerns of widespread panic and increasing anxiety in individuals. This outbreak results in mass quarantine in Egypt since middle of March 2020. Brooks et al. (2019) reviewed and reported quarantine could bring "post traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma.". Many universities decided to suspend in-person classes and evacuate students in responding to the intensifying concerns surrounding Covid-19. This action can lead to negative psychological consequences among college students. Oral health related behavior and attitudes habits correlate with oral health status and can be considered to be its predictors . There is a claim of potential connection between high bacterial load in the mouth and complications associated with Covid-19 infection. Bacteria present in the meta genome of patients severely infected with Covid-19 included high reads for Prevotella, Staphylococcus, and Fusobacterium, all usually commensal organisms of the mouth. Over 80% of patients in ICU exhibited an exceptionally high bacterial load. Accordingly, the investigators assume that good oral hygiene better to be maintained during a Covid-19 outbreak in order to reduce the bacterial load in the mouth and the risk of a bacterial super infection in case of catching the infection .
While there seems to be a common belief that psychosocial stress affects oral hygiene behavior, this assumption has rarely been proved9 Dental students, as the future providers of dental care, are ex¬pected to be role models for their patients regarding the oral hygiene practice and they supposed to be aware of the importance of preserving the oral health. Thus, we intended to select them as our population to study how the level of anxiety during pandemic could affect the practice of oral hygien
Detailed description
A cross sectional study (survey) will be conducted among dental students in faculty of dentistry Cairo University for the duration of one month from June 2020 to July 2020.
The questionnaire has three parts. The first part included demographic details. The second part included validated general anxiety disorder scale GAD-7. Questionnaire consisting of seven questions which measures students' anxiety level score. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The third part the validated self administered, structured, and close ended 15 questions that assessed the self reported oral hygiene practices 11. The questionnaire forms were kept anonymous. The questionnaire was validated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The questionnaire is going to be disseminated as google form to all the Cairo university dental students via emails .
Key inclusion criteria (1 listed)
- Student of faculty of Dentistry, Cairo University
Key exclusion criteria (1 listed)
- -
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
correlate between the level of anxiety and the practice of oral hygiene during covid-19 pandemic in dental students of Cairo university
Time frame: 2 months
By questionnaire
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 10 Mar 2022.
- Individual participant dataSharing planned: No. individual participant data are not to be shared with other researchers until publication of the study.
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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.
Mai Zakaria, Ph principal investigator
Lecturer Oral Medicine & Periodontology, Faculty of Dentistry, Cairo 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 Anxiety and Covid19, run by Cairo University at 1 site in Egypt.
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 1 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 10 Mar 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 Egypt. 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?
correlate between the level of anxiety and the practice of oral hygiene during covid-19 pandemic in dental students of Cairo university (time frame: 2 months). 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 10 Mar 2022.