- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cahide Çevik, PhD
- Número de teléfono: +905055189244
- Correo electrónico: cahide.cevik@afsu.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
|
Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The ability to independently and correctly sequence the steps of handwashing.
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Teacher-Reported Handwashing Behavior Score
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Afyon_Handwashing Education
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .