Face Mask SqueezeNCT05517629
Face Mask Habits and COVID-19 Among University Students in Cairo
An observational study of Face Mask Squeeze and COVID-19, run by Benha University at 1 site in Egypt.
Trial summary
The World Health Organization officially declared the pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a public health emergency. The virus can remain viable in aerosol form for approximately three hours before being inhaled. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Face Mask Squeeze, COVID-19, Pandemic, COVID-19
- What is being tested?
- It is an observational cross-sectional study
- How many people
- 1,455 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2021to 20 Jun 2021
- 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 28 years
- All sexes
- Adult
Study population: University students who are attending universities in Greater Cairo, Egypt
Who may be able to join
- The target population was limited to individuals aged 18 to 28 years, as those individuals can provide consent and represent the undergraduate and graduate sections.
- The participants were asked about the location of their campuses to ensure that their responses were limited only to the universities in Greater Cairo.
Who cannot join
- Individuals below the age of 18 years old are not old enough to provide consent, and individuals above the age of 28 are considered postgraduate.
- To make sure that responses arrived only from Greater Cairo universities, a question asking about the location of university campus is added to exclude responses from outside the specified area which only includes the cities of Cairo, Giza, Helwan (15th of May), Shubra El Kheima, 6th of October, Sheikh Zayed City, Badr, New Cairo (including Rehab and Fifth Settlement), New Heliopolis, Obour, Shorouk, Madinaty21.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Face Mask Habits and COVID-19: A Cross-Sectional Study of University Students During the Third Wave in Greater Cairo
The World Health Organization officially declared the pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a public health emergency. The virus can remain viable in aerosol form for approximately three hours before being inhaled. Face masks have become an essential component of the ensuing fight against coronavirus disease 2019 (COVID-19).Therefore, a multicenter cross-sectional study was conducted during the pandemic to investigate university students' face mask habits in Greater Cairo, Egypt.
Read the detailed description
Study design and participants:
This cross-sectional study is going to be carried out at a time when wearing masks in public places, transportation and universities is mandatory. The questionnaire which is designed to collect the data is targeted to college students who are attending universities in Greater Cairo, Egypt. The questionnaire will be left open for a duration of 10 days to collect the required responses.
Data collection:
The data is going to be collected from a questionnaire that we created using Google forms, consisting of 33 questions. It was written in English then translated to Arabic to be understandable to as many people as possible. The survey will be sent using a snowball sampling method to the participants through various social media applications such as: Facebook, Twitter, WhatsApp, Snapchat, and Telegram. A pilot study of the questionnaire will be pre-tested on a small sample of participants to confirm the practicability and clarity of questions to check content and face validity. In addition, the reliability will be determined by calculating Cronbach alpha. Observations of the pilot study will not be included in the final analysis.
Statistical analysis:
Dichotomous data will be expressed by numbers and frequency. Continuous variables will be expressed by means and standard deviation if within the normal distribution. Range and interquartile range will be used to express continuous data within the non-normal distribution. Data will be exported to an excel sheet from Google forms and will be analyzed by an expert using IBM SPSS Statistics program.
- Conditions
- Face Mask Squeeze, COVID-19, Pandemic, COVID-19
- Being tested
- It is an observational cross-sectional study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It is an observational cross-sectional studyOther
It is an observational cross-sectional study
| Study group | Role | What they receive |
|---|---|---|
| All the time | Students who wore face masks all the time when outside Receives: Other: It is an observational cross-sectional study | |
| Most of the time | Students who wore face masks most of the time when outside Receives: Other: It is an observational cross-sectional study | |
| Only when told to | Students who wore face masks only when they were told to when outside Receives: Other: It is an observational cross-sectional study | |
| Not At All | Students who did not wear face masks at all when outside Receives: Other: It is an observational cross-sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face Mask Habits
To evaluate participants' attitudes regarding face masks, the questions were grouped into two aspects: face mask habits (14 items) and COVID-19. Scoring Grade are four grades 1. Using face mask at all, 2. Using face mask most of time, 3. Using face mask when you are told to, and 4. Not using face mask.
Measured: April 20, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start20 Apr 2021
- Primary completion20 May 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Face Mask SqueezeStudies of the same condition, open and under way.
- More trials run by Benha 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
- 1,455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Ahmed Kamal, Benha University
- Investigators
- Manar A Kamal, MBBCh, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517629
- Sponsor's protocol ID
- FMASU R 59/2021
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face Mask Habits and COVID-19: A Cross-Sectional Study of University Students During the Third Wave in Greater Cairo
- ClinicalTrials.gov ID
- NCT05517629
- Acronym / sponsor ID
- FMASU R 59/2021
- Conditions
- Face Mask Squeeze, COVID-19, Pandemic, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,455 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 26 Aug 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.
The World Health Organization officially declared the pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a public health emergency. The virus can remain viable in aerosol form for approximately three hours before being inhaled. Face masks have become an essential component of the ensuing fight against coronavirus disease 2019 (COVID-19).Therefore, a multicenter cross-sectional study was conducted during the pandemic to investigate university students' face mask habits in Greater Cairo, Egypt.
Detailed description
Study design and participants:
This cross-sectional study is going to be carried out at a time when wearing masks in public places, transportation and universities is mandatory. The questionnaire which is designed to collect the data is targeted to college students who are attending universities in Greater Cairo, Egypt. The questionnaire will be left open for a duration of 10 days to collect the required responses.
Data collection:
The data is going to be collected from a questionnaire that we created using Google forms, consisting of 33 questions. It was written in English then translated to Arabic to be understandable to as many people as possible. The survey will be sent using a snowball sampling method to the participants through various social media applications such as: Facebook, Twitter, WhatsApp, Snapchat, and Telegram. A pilot study of the questionnaire will be pre-tested on a small sample of participants to confirm the practicability and clarity of questions to check content and face validity. In addition, the reliability will be determined by calculating Cronbach alpha. Observations of the pilot study will not be included in the final analysis.
Statistical analysis:
Dichotomous data will be expressed by numbers and frequency. Continuous variables will be expressed by means and standard deviation if within the normal distribution. Range and interquartile range will be used to express continuous data within the non-normal distribution. Data will be exported to an excel sheet from Google forms and will be analyzed by an expert using IBM SPSS Statistics program.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| All the time | – | Other: It is an observational cross-sectional studyStudents who wore face masks all the time when outside |
| Most of the time | – | Other: It is an observational cross-sectional studyStudents who wore face masks most of the time when outside |
| Only when told to | – | Other: It is an observational cross-sectional studyStudents who wore face masks only when they were told to when outside |
| Not At All | – | Other: It is an observational cross-sectional studyStudents who did not wear face masks at all when outside |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Age groups
- Adult
- Study population
- University students who are attending universities in Greater Cairo, Egypt
Key inclusion criteria (2 listed)
- The target population was limited to individuals aged 18 to 28 years, as those individuals can provide consent and represent the undergraduate and graduate sections.
- The participants were asked about the location of their campuses to ensure that their responses were limited only to the universities in Greater Cairo.
Key exclusion criteria (2 listed)
- Individuals below the age of 18 years old are not old enough to provide consent, and individuals above the age of 28 are considered postgraduate.
- To make sure that responses arrived only from Greater Cairo universities, a question asking about the location of university campus is added to exclude responses from outside the specified area which only includes the cities of Cairo, Giza, Helwan (15th of May), Shubra El Kheima, 6th of October, Sheikh Zayed City, Badr, New Cairo (including Rehab and Fifth Settlement), New Heliopolis, Obour, Shorouk, Madinaty21.
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 |
|---|---|---|
| It is an observational cross-sectional studyIt is an observational cross-sectional study | Other | All the time, Most of the time, Not At All, Only when told to |
Primary outcome
Face Mask Habits
Time frame: April 20, 2021
To evaluate participants' attitudes regarding face masks, the questions were grouped into two aspects: face mask habits (14 items) and COVID-19. Scoring Grade are four grades 1. Using face mask at all, 2. Using face mask most of time, 3. Using face mask when you are told to, and 4. Not using face mask.
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 26 Aug 2022.
- Individual participant dataSharing planned: Undecided
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.
Manar A Kamal, MBBCh principal investigator
Benha 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 Face Mask Squeeze and COVID-19, run by Benha 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 2 inclusion and 2 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 26 Aug 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?
Face Mask Habits (time frame: April 20, 2021). 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 26 Aug 2022.