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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05572840
Other study ID # 2022-SBB-0209
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date March 10, 2023

Study information

Verified date March 2023
Source Bartin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 273
Est. completion date March 10, 2023
Est. primary completion date March 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility Inclusion Criteria: - Being between the ages of 11-14, - Being a student of Bartin Ertugrul 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 Bartin Ertugrul 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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).

Locations

Country Name City State
Turkey Bartin Ertugrul Gazi Secondary School Bartin

Sponsors (2)

Lead Sponsor Collaborator
Bartin University The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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. 6 months
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