CoronavirusNCT05572840
Wear Your Mask, Wash Your Hands, Don't Get COVID-19
A study testing Training and activities in people with Coronavirus and Child, Only, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, Child, Only
- What is being tested?
- Training and activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bartin Ertugrul Gazi Secondary School
Bartın, 74100
About this study
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.
Read the 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.
- Conditions
- Coronavirus, Child, Only
- Being tested
- Training and activities
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and activitiesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Training and activities | Experimental | 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). Receives: Other: Training and activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
"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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Oct 2022
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Aylin Kurt, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572840
- Sponsor's protocol ID
- 2022-SBB-0209
- Status last verified
- Mar 2023
- First submitted
- 5 Oct 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wear Your Mask, Wash Your Hands, Don't Get COVID-19
- ClinicalTrials.gov ID
- NCT05572840
- Acronym / sponsor ID
- 2022-SBB-0209
- Conditions
- Coronavirus, Child, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training and activities | Experimental | Other: Training and activitiesThe 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). |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training and activitiesThe 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). | Other | Training and activities |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training and activities in people with Coronavirus and Child, Only, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.