Clinical trial NCT04474028: An Epidemiological Investigation on the Correct Wearing of Face Mask
Official title: An Epidemiological Investigation on the Prevention of Respiratory Infectious Diseases by Wearing Mask Correctly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Infectious Diseases
Lead sponsor: Fuwai Yunnan Cardiovascular Hospital
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 6000
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Those who are 7 years old or above, have the ability of autonomous behavior and language expression, are willing to take the test.

Brief summary: The purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.

Detailed description: 1. Overall design：This study uses the methods of cross-sectional survey and chance sampling.
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.

Eligibility criteria: Inclusion Criteria:

1. Healthy people with autonomous behavior ability and language expression ability who are older than or equal to 7 years old, Persons under the age of 18 need to obtain the consent of their legal guardians；
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:

1. People with a history of allergies, including those who are allergic to pollen, dust mites, etc；
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.

Primary outcomes:
measure: can or can't fell bitterness
timeFrame: Immediately after spray test
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital, Beijing
state: Beijing
city: Taizhou
country: China
facility: Taizhou Health Bureau
state: Jiangsu
city: Jinzhong
country: China
facility: Jiexiu Health Bureau
state: Shanxi
city: Yuncheng
country: China
facility: Yuanqu Health Bureau
state: Shanxi
city: Kunming
country: China
facility: Fuwai Yunnan Cardiovascular Hospital
state: Yunnan
city: Qujing
country: China
facility: Luliang Health Bureau
state: Yunnan
city: Qujing
country: China
facility: Shizong Health Bureau
state: Yunnan
city: Qujing
country: China
facility: Luoping Health Bureau
state: Yunnan
Study officials:
affiliation: Fuwai Yunnan Cardiovascular Hospital
name: Xiang-Bin Pan
role: PRINCIPAL_INVESTIGATOR
References: