An Epidemiological Investigation on Correct Wearing of Mask by Hood Test

NCT04497753 | Completed

• 1 other identifier: 2020-KZLXB-02-02
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 8

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.

Conditions

Respiratory Infectious Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Can't fell bitterness

1. 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, the number of sprays should be the same as that of the sensitivity test. 2. Record whether the subject feels bitterness, if there is no feeling, the test is over.

Can fell bitterness

1. 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, the number of sprays should be the same as that of the sensitivity test. 2. Record whether the subject feels bitterness, If there is a sensation, put the adhesive strip on the upper edge of the subject's mask and put on the hood to carry out the above fitness test again. 3. Record whether the subject feels bitterness, if not, the test is over. If there is any sensation, ask the subject to change to a medical surgical mask, and put an adhesive strip on the upper edge of the mask, and put on the hood to carry out the above fitness test again.

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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；
• 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；
• People who volunteered to take part in the study；
• There was no respiratory infection in nearly one month.

You may not qualify if:

• People with a history of allergies, including those who are allergic to pollen, dust mites, etc；
• People with any history of drug allergy；
• People who have participated in the experiment are not allowed to participate in this study for the second time;
• Pregnant women；
• The healer after COVID-19 's infection；
• 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；
• Those who are participating in clinical trials of other drugs / devices；
• Subjects with poor compliance or unwilling to cooperate with the operation as required；
• The researchers believe that any other situation that may affect the evaluation of the study.

Sponsors & Collaborators

• Fuwai Yunnan Cardiovascular Hospital: lead

Study Sites (8)

Fuwai hospital, Beijing

Beijing, Beijing Municipality, 100037, China

Location

Taizhou Health Bureau

Taizhou, Jiangsu, 225300, China

Location

Bin Health Wen

Jinzhong, Shanxi, 032005, China

Location

Yuanqu Health Bureau

Yuncheng, Shanxi, 043700, China

Location

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, 655601, China

Location

Luliang Health Bureau

Qujing, Yunnan, 655601, China

Location

Shizong Health Bureau

Qujing, Yunnan, 655700, China

Location

Luoping Health Bureau

Qujing, Yunnan, 655816, China

Location

Study Officials

• Lin Duo

  Fuwai Yunnan Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 4, 2020
• Study Start: June 19, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)