Handwashing BehaviorNCT07607717
Game-Based Handwashing Education in Preschool Children
A study testing Game-Based Handwashing Education in people with Handwashing Behavior, run by Afyonkarahisar Health Sciences University.
Trial summary
This study aims to evaluate the effect of a game-based handwashing education program, which will be developed based on the Health Belief Model, on the handwashing behaviors of preschool children. Read more about this study
- Who is it for?
- Ages 60 to 83 monthsHealthy volunteers can take part
- Conditions the study is for
- Handwashing Behavior
- What is being tested?
- Game-Based Handwashing Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 83 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participation in at least 80% of the planned 8 game sessions (at least 7 sessions)
- Children aged 60-83 months enrolled in the preschool education institution where the research is conducted
- Children who have the cognitive ability to understand the given instructions and who do not have any physical condition preventing them from performing handwashing behavior
- Children for whom written parental consent for participation in the study has been obtained
- Children whose primary caregiver agrees to complete the parent observation form provided within the scope of the study, has Turkish literacy skills, and provides informed voluntary consent
Who cannot join
- Children outside the 60-83 months age range
- Children with a physical disability that may prevent them from performing handwashing behavior
- Children with cognitive impairments at a level that would make it difficult to understand the given instructions and actively participate in the game
- Children for whom written parental consent for participation in the study has not been obtained
- Children whose parents/caregivers do not agree to complete the parent observation form provided within the scope of the study, do not have Turkish literacy skills, or do not provide informed voluntary consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of a Game-Based Handwashing Education on Handwashing Behavior in Preschool Children
This study aims to evaluate the effect of a game-based handwashing education program, which will be developed based on the Health Belief Model, on the handwashing behaviors of preschool children. Preschool children are considered more vulnerable to respiratory and gastrointestinal infections due to their immature immune systems and close contact with peers in school settings.
Within the scope of this project, a game called "Clean Hands" will be developed and a game-based handwashing education program will be implemented. The study will be conducted using a quasi-experimental pretest-posttest control group design with children aged 60-83 months attending two preschools with similar demographic characteristics. Children will be assigned to intervention and control groups.
Read more
Children in the intervention group will participate in the developed game as a group activity once a week for eight weeks. The control group will not receive any game-based intervention during the study period; however, the same game will be provided to the control group after completion of the intervention sessions.
Data will be collected using teacher observation forms, parent observation forms, handwashing step sequencing assessment forms, and handwashing behavior discrimination assessment forms. The findings are expected to contribute to the development of effective game-based health education strategies for preschool children.
Read the detailed description
Hand hygiene is considered an important health behavior in preventing infectious diseases among preschool children. However, establishing proper handwashing behavior as a sustainable habit in this age group can be challenging. Game-based learning approaches are considered effective methods for promoting health behaviors because they support children's active participation.
The "Clean Hands" game to be developed in this study will be structured based on the Health Belief Model. The game design will incorporate the components of perceived benefits, perceived susceptibility, self-efficacy, and cues to action. The game will include cards representing daily life situations, handwashing step sequencing activities, joker cards, and reward stickers. The intervention aims to help children both recognize situations requiring handwashing and correctly perform the handwashing steps.
The study will be conducted using a quasi-experimental pretest-posttest control group design. Children in the intervention group will participate in a group game session once a week for eight weeks. Before the intervention, children will receive a brief handwashing orientation, and short reminder activities will be used throughout the intervention process. No game-based intervention will be applied to the control group during the study period.
Data will be collected using teacher and parent observation forms as well as assessment tools evaluating children's handwashing behaviors. In addition, a follow-up assessment will be conducted after the intervention to evaluate the sustainability of the intervention effects.
- Conditions
- Handwashing Behavior
- Being tested
- Game-Based Handwashing Education
- Keywords
- Hand Hygiene, Preschool Children, Game-Based Learning, Health Belief Model, Health Education, Behavior Change, School Health
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-Based Handwashing EducationBehavioural
The intervention consists of the "Clean Hands" game-based handwashing education program developed based on the Health Belief Model. The intervention is designed for preschool children and includes game activities targeting perceived benefits, perceived susceptibility, self-efficacy, and cues to action related to handwashing behavior.
The game includes daily life scenario cards, handwashing step sequencing activities, joker cards, reminder prompts, and reward stickers. Before the intervention sessions, children will receive a brief handwashing orientation supported by visual materials and video demonstrations. The intervention will be implemented as a group activity once a week for eight weeks. Short reminder activities will be used throughout the intervention process to reinforce correct handwashing behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The study will be conducted in two preschools with similar demographic characteristics. To prevent interaction between the intervention and control groups, each preschool will be assigned as a separate study group. Data collection tools will be administered to both groups at baseline. Before the intervention sessions, children in the intervention group will receive a brief handwashing orientation lasting approximately 10 minutes. Following this orientation, the developed "Clean Hands" game will be implemented as a group activity once a week for eight weeks. Short reminder activities will be used throughout the process to reinforce correct handwashing behaviors. Receives: Behavioral: Game-Based Handwashing Education |
| Standard of care group | No intervention | Participants in the control group will not receive any game-based handwashing intervention during the study period. Participants will only be included in the data collection procedures conducted at baseline, post-test, and follow-up assessments. After completion of the study, children in the control group will receive a brief handwashing education session and the "Clean Hands" game will be implemented once. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to independently and correctly sequence the steps of handwashing.
The ability to sequencing handwashing steps will be used as a performance-based assessment to determine the level at which children can perform handwashing behavior in the correct order and completeness. In this assessment, children will be given visual cards representing the steps of handwashing and will be asked to arrange these cards in order with the statement, "Now let's wash our hands. Which one do we do first when washing our hands? Can you arrange the cards in order?" 1 point will be given for each step in the correct order, and the total score obtained will reflect the children's handwashing skill level. The assessment will be conducted before the study, at the end of the study, and 3 months after the completion of the application. This form will be administered by the researchers.
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Children's Handwashing Behavior Discrimination Skill Score
The handwashing behavior discrimination skill of children will be evaluated using 20 picture cards containing correct and incorrect handwashing behaviors. Children will be asked whether the child in each picture is performing the behavior correctly. "Yes" responses will be scored as 1 point, while "No" and "I don't know" responses will be scored as 0 points. Total scores range from 0 to 20, with higher scores indicating better handwashing behavior discrimination skills. Assessments will be conducted at baseline, immediately after the intervention, and 3 months after the intervention
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Secondary outcomes (2)
Teacher-Reported Handwashing Behavior Score
The Teacher Observation Form was developed to evaluate children's handwashing initiation behaviors. The form includes situations that teachers can naturally observe during daily classroom routines, such as after toilet use, before meals, and after play activities. Teachers will respond to each item based on their own observations to determine in which situations children display handwashing behaviors in the school environment. The form includes the response options "yes," "no," and "not applicable." "Yes" responses will be scored as 1 point and "no" responses as 0 points. Items related to situations not encountered or not observable in the child's daily life (e.g., using school transportation or public transportation) will be marked as "not applicable" and excluded from the total score calculation. For each child, the handwashing behavior score will be calculated proportionally based on the observed items. The form will be completed by teachers at baseline, immediately after the inter
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Parent-Reported Handwashing Behavior Score
The Parent Observation Form will be used to evaluate both the situations in which children perform handwashing behaviors and how they perform these behaviors in the home environment. The form includes items related to daily life situations such as after toilet use, before/after meals, after returning home from outside, and after contact with animals. The response options are "yes," "no," and "not applicable." "Yes" responses will be scored as 1 point and "no" responses as 0 points. Items related to situations not encountered or not observable in the child's daily life (e.g., using school transportation or public transportation) will be marked as "not applicable" and excluded from the total score calculation. For each child, the handwashing behavior score will be calculated proportionally based on the observed items. The form will be completed by parents at baseline, immediately after the intervention, and 3 months after the intervention.
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Handwashing BehaviorStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either the intervention group or the control group based on the preschool they attend. The intervention group will receive the game-based handwashing education, while the control group will receive no intervention during the study period.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cahide Çevik, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607717
- Sponsor's protocol ID
- Afyon_Handwashing Education
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data could be shared in anonymized form; however, no formal data sharing plan has been established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Game-Based Handwashing Education on Handwashing Behavior in Preschool Children
- ClinicalTrials.gov ID
- NCT07607717
- Acronym / sponsor ID
- Afyon_Handwashing Education
- Conditions
- Handwashing Behavior
- Keywords
- Hand Hygiene, Preschool Children, Game-Based Learning, Health Belief Model, Health Education, Behavior Change, School Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 May 2026 (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.
This study aims to evaluate the effect of a game-based handwashing education program, which will be developed based on the Health Belief Model, on the handwashing behaviors of preschool children. Preschool children are considered more vulnerable to respiratory and gastrointestinal infections due to their immature immune systems and close contact with peers in school settings.
Within the scope of this project, a game called "Clean Hands" will be developed and a game-based handwashing education program will be implemented. The study will be conducted using a quasi-experimental pretest-posttest control group design with children aged 60-83 months attending two preschools with similar demographic characteristics. Children will be assigned to intervention and control groups.
Children in the intervention group will participate in the developed game as a group activity once a week for eight weeks. The control group will not receive any game-based intervention during the study period; however, the same game will be provided to the control group after completion of the intervention sessions.
Data will be collected using teacher observation forms, parent observation forms, handwashing step sequencing assessment forms, and handwashing behavior discrimination assessment forms. The findings are expected to contribute to the development of effective game-based health education strategies for preschool children.
Detailed description
Hand hygiene is considered an important health behavior in preventing infectious diseases among preschool children. However, establishing proper handwashing behavior as a sustainable habit in this age group can be challenging. Game-based learning approaches are considered effective methods for promoting health behaviors because they support children's active participation.
The "Clean Hands" game to be developed in this study will be structured based on the Health Belief Model. The game design will incorporate the components of perceived benefits, perceived susceptibility, self-efficacy, and cues to action. The game will include cards representing daily life situations, handwashing step sequencing activities, joker cards, and reward stickers. The intervention aims to help children both recognize situations requiring handwashing and correctly perform the handwashing steps.
The study will be conducted using a quasi-experimental pretest-posttest control group design. Children in the intervention group will participate in a group game session once a week for eight weeks. Before the intervention, children will receive a brief handwashing orientation, and short reminder activities will be used throughout the intervention process. No game-based intervention will be applied to the control group during the study period.
Data will be collected using teacher and parent observation forms as well as assessment tools evaluating children's handwashing behaviors. In addition, a follow-up assessment will be conducted after the intervention to evaluate the sustainability of the intervention effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to either the intervention group or the control group based on the preschool they attend. The intervention group will receive the game-based handwashing education, while the control group will receive no intervention during the study period.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Game-Based Handwashing EducationThe study will be conducted in two preschools with similar demographic characteristics. To prevent interaction between the intervention and control groups, each preschool will be assigned as a separate study group. Data collection tools will be administered to both groups at baseline. Before the intervention sessions, children in the intervention group will receive a brief handwashing orientation lasting approximately 10 minutes. Following this orientation, the developed "Clean Hands" game will be implemented as a group activity once a week for eight weeks. Short reminder activities will be used throughout the process to reinforce correct handwashing behaviors. |
| Standard of care group | No intervention | –Participants in the control group will not receive any game-based handwashing intervention during the study period. Participants will only be included in the data collection procedures conducted at baseline, post-test, and follow-up assessments. After completion of the study, children in the control group will receive a brief handwashing education session and the "Clean Hands" game will be implemented once. |
Who may qualify
- Ages
- 60 to 83 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participation in at least 80% of the planned 8 game sessions (at least 7 sessions)
- Children aged 60-83 months enrolled in the preschool education institution where the research is conducted
- Children who have the cognitive ability to understand the given instructions and who do not have any physical condition preventing them from performing handwashing behavior
- Children for whom written parental consent for participation in the study has been obtained
- Children whose primary caregiver agrees to complete the parent observation form provided within the scope of the study, has Turkish literacy skills, and provides informed voluntary consent
Key exclusion criteria (5 listed)
- Children outside the 60-83 months age range
- Children with a physical disability that may prevent them from performing handwashing behavior
- Children with cognitive impairments at a level that would make it difficult to understand the given instructions and actively participate in the game
- Children for whom written parental consent for participation in the study has not been obtained
- Children whose parents/caregivers do not agree to complete the parent observation form provided within the scope of the study, do not have Turkish literacy skills, or do not provide informed voluntary consent
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 |
|---|---|---|
| Game-Based Handwashing EducationThe intervention consists of the "Clean Hands" game-based handwashing education program developed based on the Health Belief Model. The intervention is designed for preschool children and includes game activities targeting perceived benefits, perceived susceptibility, self-efficacy, and cues to action related to handwashing behavior. The game includes daily life scenario cards, handwashing step sequencing activities, joker cards, reminder prompts, and reward stickers. Before the intervention sessions, children will receive a brief handwashing orientation supported by visual materials and video demonstrations. The intervention will be implemented as a group activity once a week for eight weeks. Short reminder activities will be used throughout the intervention process to reinforce correct handwashing behaviors. | Behavioural | Experimental Group |
Primary outcome
The ability to independently and correctly sequence the steps of handwashing.
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
The ability to sequencing handwashing steps will be used as a performance-based assessment to determine the level at which children can perform handwashing behavior in the correct order and completeness. In this assessment, children will be given visual cards representing the steps of handwashing and will be asked to arrange these cards in order with the statement, "Now let's wash our hands. Which one do we do first when washing our hands? Can you arrange the cards in order?" 1 point will be given for each step in the correct order, and the total score obtained will reflect the children's handwashing skill level. The assessment will be conducted before the study, at the end of the study, and 3 months after the completion of the application. This form will be administered by the researchers.
Children's Handwashing Behavior Discrimination Skill Score
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
The handwashing behavior discrimination skill of children will be evaluated using 20 picture cards containing correct and incorrect handwashing behaviors. Children will be asked whether the child in each picture is performing the behavior correctly. "Yes" responses will be scored as 1 point, while "No" and "I don't know" responses will be scored as 0 points. Total scores range from 0 to 20, with higher scores indicating better handwashing behavior discrimination skills. Assessments will be conducted at baseline, immediately after the intervention, and 3 months after the intervention
2 secondary outcomes
Teacher-Reported Handwashing Behavior Score
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
Parent-Reported Handwashing Behavior Score
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. Individual participant data could be shared in anonymized form; however, no formal data sharing plan has been established for this study.
Related trials for Handwashing Behavior
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Effect of Digital Method-Based Hand Hygiene Education on Handwashing Skills in Primary School Students
Hand Hygiene, School Health, Primary School Students, Health Education
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.
Questions about this trial
What is this clinical trial studying?
A study testing Game-Based Handwashing Education in people with Handwashing Behavior, run by Afyonkarahisar Health Sciences University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cahide Çevik, PhD (+905055189244, cahide.cevik@afsu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability to independently and correctly sequence the steps of handwashing. (time frame: Baseline, immediately after the intervention, and 3 months after the intervention). 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 26 May 2026.