- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07607717
Game-Based Handwashing Education in Preschool Children
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cahide Çevik, PhD
- Phone Number: +905055189244
- Email: cahide.cevik@afsu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
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.
|
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. |
|
No Intervention: Standard of care group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, immediately after the intervention, and 3 months after the intervention
|
|
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
|
Baseline, immediately after the intervention, and 3 months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Teacher-Reported Handwashing Behavior Score
Time Frame: Baseline, immediately after the intervention, and 3 months after the intervention
|
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
|
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
|
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.
|
Baseline, immediately after the intervention, and 3 months after the intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Afyon_Handwashing Education
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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