An Epidemiological Investigation on the Correct Wearing of Face Mask

Respiratory Infectious Diseases Clinical Trial

Official title:

An Epidemiological Investigation on the Prevention of Respiratory Infectious Diseases by Wearing Mask Correctly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474028
• Other study ID #: 2020-KZLXB-01
• Status: Completed
• Start date: June 19, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: November 2020
• Source: Fuwai Yunnan Cardiovascular Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Infectious Diseases

Locations

Country	Name	City	State
China	Fuwai hospital, Beijing	Beijing	Beijing
China	Jiexiu Health Bureau	Jinzhong	Shanxi
China	Fuwai Yunnan Cardiovascular Hospital	Kunming	Yunnan
China	Luliang Health Bureau	Qujing	Yunnan
China	Luoping Health Bureau	Qujing	Yunnan
China	Shizong Health Bureau	Qujing	Yunnan
China	Taizhou Health Bureau	Taizhou	Jiangsu
China	Yuanqu Health Bureau	Yuncheng	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fuwai Yunnan Cardiovascular Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	can or can't fell bitterness	Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face.; If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.	Immediately after spray test