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An Epidemiological Investigation on the Correct Wearing of Face Mask

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04474028
Recruitment Status : Completed
First Posted : July 16, 2020
Last Update Posted : November 6, 2020
Information provided by (Responsible Party):
Fuwai Yunnan Cardiovascular Hospital

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 6000 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: An Epidemiological Investigation on the Prevention of Respiratory Infectious Diseases by Wearing Mask Correctly
Actual Study Start Date : June 19, 2020
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

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.

Primary Outcome Measures :
  1. can or can't fell bitterness [ Time Frame: Immediately after spray test ]
    1. Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face.
    2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04474028

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China, Beijing
Fuwai hospital, Beijing
Beijing, Beijing, China, 100037
China, Jiangsu
Taizhou Health Bureau
Taizhou, Jiangsu, China, 225300
China, Shanxi
Jiexiu Health Bureau
Jinzhong, Shanxi, China, 032005
Yuanqu Health Bureau
Yuncheng, Shanxi, China, 043700
China, Yunnan
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China, 650000
Luliang Health Bureau
Qujing, Yunnan, China, 655601
Shizong Health Bureau
Qujing, Yunnan, China, 655700
Luoping Health Bureau
Qujing, Yunnan, China, 655816
Sponsors and Collaborators
Fuwai Yunnan Cardiovascular Hospital
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Principal Investigator: Xiang-Bin Pan Fuwai Yunnan Cardiovascular Hospital
  Study Documents (Full-Text)

Documents provided by Fuwai Yunnan Cardiovascular Hospital:
Informed Consent Form  [PDF] November 4, 2020

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Responsible Party: Fuwai Yunnan Cardiovascular Hospital Identifier: NCT04474028    
Other Study ID Numbers: 2020-KZLXB-01
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases