NCT07607717

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

Hand HygienePreschool ChildrenGame-Based LearningHealth Belief ModelHealth EducationBehavior ChangeSchool Health

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    Baseline, immediately after the intervention, and 3 months after the intervention

Secondary Outcomes (2)

  • Teacher-Reported Handwashing Behavior Score

    Baseline, immediately after the intervention, and 3 months after the intervention

  • Parent-Reported Handwashing Behavior Score

    Baseline, immediately after the intervention, and 3 months after the intervention

Study Arms (2)

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.

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.

Interventions

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.

Experimental Group

Eligibility Criteria

Age60 Months - 83 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Cahide Çevik, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Public health nursing

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 26, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data could be shared in anonymized form; however, no formal data sharing plan has been established for this study.