An Epidemiological Investigation on the Correct Wearing of Face Mask

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Infectious Diseases

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.

• Study Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai hospital, Beijing
  • Jiangsu
    • Taizhou, Jiangsu, China, 225300
      • Taizhou Health Bureau
  • Shanxi
    • Jinzhong, Shanxi, China, 032005
      • Jiexiu Health Bureau
    • Yuncheng, Shanxi, China, 043700
      • Yuanqu Health Bureau
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • Fuwai Yunnan Cardiovascular Hospital
    • Qujing, Yunnan, China, 655601
      • Luliang Health Bureau
    • Qujing, Yunnan, China, 655700
      • Shizong Health Bureau
    • Qujing, Yunnan, China, 655816
      • Luoping Health Bureau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fuwai Yunnan Cardiovascular Hospital
• Investigators: Principal Investigator: Xiang-Bin Pan, Fuwai Yunnan Cardiovascular Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 19, 2020
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: July 12, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2020-KZLXB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No