An Epidemiological Investigation on Correct Wearing of Mask by Direct Spray Test

NCT ID: NCT04497675

Last Updated: 2020-10-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-19

Study Completion Date

2020-08-31

Brief Summary

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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

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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 Are there any obvious gaps or whether the cotton around the mask is blown 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, sensitive subjects can participate in the direct spray test.

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.

Conditions

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Respiratory Infectious Diseases

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Can't fell bitterness

1. 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, and the subject can stop the spray as soon as he/she smells bitterness.
2. Record whether the subject feels bitterness, if not, let the subject puts on the hood, carry out the fitness test again and record the results.

No interventions assigned to this group

Can fell bitterness

1. 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, and the subject can stop the spray as soon as he/she smells bitterness.
2. If the subject feels bitterness, stick the adhesive strip on the upper edge of the subject's mask and perform the direct spray test again. Record whether the subject feels bitterness, if not, ask the subject to put on the hood, carry out the fitness test again and record it. If there is a feeling, ask the subject to change to a medical surgical mask and put an adhesive strip on the upper edge of the mask, then conduct the direct spray test again, and record the test results.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fuwai Yunnan Cardiovascular Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duo lin

Role: PRINCIPAL_INVESTIGATOR

Fuwai Yunnan Cardiovascular Hospital

Locations

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Fuwai hospital, Beijing

Beijing, Beijing Municipality, China

Site Status

Taizhou Health Bureau

Taizhou, Jiangsu, China

Site Status

Jiexiu Health Bureau

Jinzhong, Shanxi, China

Site Status

Yuanqu Health Bureau

Yuncheng, Shanxi, China

Site Status

Shizong Health Bureau

Qujing, Yunnan, China

Site Status

Lin Health Duo

Qujing, Yunnan, China

Site Status

Luliang Health Bureau

Qujing, Yunnan, China

Site Status

Luoping Health Bureau

Qujing, Yunnan, China

Site Status

Countries

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China

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2020-KZLXB-02-01

Identifier Type: -

Identifier Source: org_study_id

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