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Wear Your Mask, Wash Your Hands, Don't Get COVID-19

Primary Purpose

Coronavirus, Child, Only

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Training and activities
Sponsored by
Bartın Unıversity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronavirus

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bartin Ertugrul Gazi Secondary School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training and activities

Arm Description

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).

Outcomes

Primary Outcome Measures

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
"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.
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
"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.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2022
Last Updated
March 12, 2023
Sponsor
Bartın Unıversity
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05572840
Brief Title
Wear Your Mask, Wash Your Hands, Don't Get COVID-19
Official Title
Wear Your Mask, Wash Your Hands, Don't Get COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bartın Unıversity
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Child, Only

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training and activities
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Training and activities
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Description
"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.
Time Frame
6 months
Title
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
Description
"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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Bartin Ertugrul Gazi Secondary School
City
Bartın
ZIP/Postal Code
74100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Wear Your Mask, Wash Your Hands, Don't Get COVID-19

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