- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05572840
Wear Your Mask, Wash Your Hands, Don't Get COVID-19
The aim of this project is to determine the effect of training given to children aged 11-14 on hand hygiene and mask use. In line with this general purpose, the hypotheses of the research are as follows:
H0= Education given to children aged 11-14 on hand hygiene and mask use has no effect on children's hand hygiene and mask use behaviors.
H1= With the education given to children aged 11-14 on hand hygiene and mask use, children will exhibit more correct hand hygiene and mask use behaviors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The universe of the research will consist of 273 secondary school students between the ages of 11-14 according to the education and training of Bartın Ertuğrul Gazi Secondary School. The children's inclusion criteria are as follows:
- Being between the ages of 11-14,
- Being a student of Bartın Ertuğrul Gazi Secondary School,
- The child and his parents agree to participate in the project,
- The child's speech and visual impairment do not have any handicap that would force or hinder communication.
Intervention: Once enrolled and consent is documented, eligible subjects will participate in the study for approximately three months. Participants will be expected to attend 2 training sessions and 2 activities (wearing masks and hygienic hand washing), each is up to one hour in length. Follow-up will be made at the beginning of the training, right after the last training. Data analysis will begin once all trainings and activities have been completed. Investigators anticipate completing the study, including primary analyses, within six months from the date recruitment begins.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bartın, Turkey, 74100
- Bartin Ertugrul Gazi Secondary School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being between the ages of 11-14,
- Being a student of Bartın Ertuğrul Gazi Secondary School,
- The child and his parents agree to participate in the project,
- The child's speech and visual impairment do not have any handicap that would force or hinder communication.
Exclusion Criteria:
- Not to be between the ages of 11-14,
- Not being a student of Bartın Ertuğrul Gazi Secondary School,
- The child and his parents do not agree to participate in the project,
- The child's speech and vision impairment, or any disability that would force or hinder communication.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training and activities
The training program consists of two modules.
The 1st module consists of a theoretical lecture (PowerPoint presentation) and an activity (application of hygienic handwashing by the researcher) explaining what to do for hygienic handwashing.
The 2nd module consists of the theoretical explanation (PowerPoint presentation) in which the correct mask usage is explained and the activity (the "make your own mask" activity by painting the masks).
|
The training program consists of two modules.
The 1st module consists of a theoretical lecture (powerpoint presentation) and an activity (application of hygienic handwashing by the researcher) explaining what to do for hygienic handwashing.
The 2nd module consists of the theoretical explanation (powerpoint presentation) in which the correct mask usage is explained and the activity (the "make your own mask" activity by painting the masks).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the mean scores obtained by the children in the intervention group from the "Hand Hygiene Behavior Form" before and after the trainings and activities
Time Frame: 6 months
|
"Hand Hygiene Behavior Form" will be completed before the training and activities that gather quantitative data that will address hand hygiene behavior in children.
A minimum of 0 points and a maximum of 42 points can be obtained from the form.
The higher scores mean the higher proper hand hygien behaviors.
This scale will also be completed after the training and activities.
The quantitative data will be used to measure the change in the children's hand hygiene behavior before, and after the proposed intervention.
Data will be analyzed using Statistical Package for the Social Sciences package program.
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6 months
|
Change of the mean scores obtained by the children in the intervention group from the "Behavior Form for Using Masks" before and after the trainings and activities
Time Frame: 6 months
|
"Behavior Form for Using Masks" will be completed before the training and activities that gathers quantitative data that will address using masks behavior in children.
A minimum of 0 points and a maximum of 42 points can be obtained from the form.
The higher scores mean the higher proper using masks behaviors.
This scale will also be completed after the training and activities.
The quantitative data will be used to measure the change in the children's using masks behavior before, and after the proposed intervention.
Data will be analyzed using Statistical Package for the Social Sciences package program.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-SBB-0209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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