An Epidemiological Investigation on the Correct Wearing of Face Mask
NCT ID: NCT04474028
Last Updated: 2020-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6000 participants
OBSERVATIONAL
2020-06-19
2020-08-31
Brief Summary
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Detailed Description
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2. Sign the Informed Consent Form.
3. Investigation on the basic situation of personnel: The gender, age and education level of the subjects were analyzed as the factors influencing whether the mask was worn correctly or not.
4. Investigation on the types of wearing masks： 1) The types of masks worn by the subjects were recorded as the basis of stratified statistics.
2\) Mask suitability testing：
1. Visual inspection whether the mask is close to the face with obvious gaps.
2. Breathing test whether it can blow the cotton wool under the eyes when the subject taking a deep breath.
3. Spray test The FT-30 qualitative fitness test system of 3M company was used to test the suitability and correctness of wearing mask.
In the spray test, all subjects underwent a sensitivity test to prove their ability to smell the bitterness of the reagent, and then were randomly divided into a hood group and a direct spray group.
In order to objectively reflect the overall situation of the subjects, it is necessary to cover many ages and educational levels of men and women.
Each subject participated in the study for about 5-6 minutes, and the total duration of this study was about 3 months.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Study Groups
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Hood group
The subject wears a mask and a hood, opens his/her mouth to breathe, and sticks out his/her tongue properly. Using the fitness test reagent to spray into the hood.
No interventions assigned to this group
Direct spray group
The subject wears a mask and his/her tongue sticks out properly. The suitability test reagent is used to spray directly to the subject from the top, bottom, left side and right side twice respectively.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. The subjects and / or their legal guardians have the ability to understand the contents of the study and to participate in all the research processes with the subjects；
3. People who volunteered to take part in the study；
4. There was no respiratory infection in nearly one month.
Exclusion Criteria
2. People with any history of drug allergy；
3. People who have participated in the experiment are not allowed to participate in this study for the second time;
4. Pregnant women；
5. The healer after COVID-19 's infection；
6. After questioning, it was found that the subjects were the factors that affected the study, such as dysosmia, or those who had decreased olfactory ability due to disease, or facial paralysis, which affected the judgment of the test；
7. Those who are participating in clinical trials of other drugs / devices；
8. Subjects with poor compliance or unwilling to cooperate with the operation as required；
9. The researchers believe that any other situation that may affect the evaluation of the study.
7 Years
ALL
Yes
Sponsors
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Fuwai Yunnan Cardiovascular Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiang-Bin Pan
Role: PRINCIPAL_INVESTIGATOR
Fuwai Yunnan Cardiovascular Hospital
Locations
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Fuwai hospital, Beijing
Beijing, Beijing Municipality, China
Taizhou Health Bureau
Taizhou, Jiangsu, China
Jiexiu Health Bureau
Jinzhong, Shanxi, China
Yuanqu Health Bureau
Yuncheng, Shanxi, China
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China
Luliang Health Bureau
Qujing, Yunnan, China
Shizong Health Bureau
Qujing, Yunnan, China
Luoping Health Bureau
Qujing, Yunnan, China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2020-KZLXB-01
Identifier Type: -
Identifier Source: org_study_id