- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05395988
Hand Hygiene of Kindergarten Children
Hand Hygiene of Kindergarten Children: Understanding the Effect of Live Feedback on Hand Washing Behavior, Self-Efficacy and Motivation of Young Children
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children attending kindergarten
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The control group receives no screen next to the sink.
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|
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Experimental: Instruction group
The reward group receives a screen next to each sink in kindergarten.
On the screen, hand washing instructions are shown during hand washing.
After a defined time period, the screen is removed.
|
Tablet displaying animated hand washing instructions
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Experimental: Reward group
The reward group receives a screen next to each sink in kindergarten. On the screen, hand washing instructions are shown during hand washing. If hands are washed correctly (time and soap usage), a reward (animal animation) is shown on the screen. After a defined time period, the screen is removed. |
Tablet displaying animated hand washing instructions and animated animals as reward
|
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Experimental: Reward plus instruction-only group
The reward plus instruction group receives a screen next to each sink in kindergarten. On the screen, hand washing instructions are shown during hand washing. If hands are washed correctly (time and soap usage), a reward (animal animation) is shown on the screen. After a defined time period, the screen only shows instructions, the reward is not shown anymore. After a defined time period, the screen is removed. |
Tablet displaying animated hand washing instructions
Tablet displaying animated hand washing instructions and animated animals as reward
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handwashing motivation of children (measured as soaping time by digital system).
Time Frame: up to 3 months
|
Motivation of children, measured as soaping time (activity level) by digital system.
Activity level is used as a proxy for motivation.
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up to 3 months
|
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Handwashing motivation of children (investigated with observation questionnaire for children in kindergarten)
Time Frame: up to 3 months
|
Motivation of children, investigated with observation questionnaire (covering different steps of handwashing) of children while washing hands in kindergarten.
In the observation questionnaire, each step of handwashing is rated on a scale (with highest number meaning highest compliance to handwashing instructions).
Activity level (as measured by observation questionnaire) is used as a proxy for motivation.
|
up to 3 months
|
|
Self-efficacy of children (investigated with interviews with children)
Time Frame: up to 3 months
|
Self-efficacy of children is measured in interviews with the children.
The interview questionnaires for the children are based on Bandura's concept of self-efficacy.
The scale that is used in the interview questionnaires is specially developed for our experiment.
|
up to 3 months
|
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Self-efficacy of children (investigated with interviews with staff)
Time Frame: up to 3 months
|
Self-efficacy of children is measured in interviews with the kindergarten staff.
The interview questionnaires for the staff (for evaluating children's self-efficacy) are based on Bandura's concept of self-efficacy.
The scale that is used in the interview questionnaires is specially developed for our experiment.
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sickness days of children (as recorded by kindergarten management)
Time Frame: Up to one year
|
Sickness days of children, recorded by kindergarten management on a daily basis.
|
Up to one year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sanna Salanterä, Prof. Dr., University of Turku
- Principal Investigator: Joanna Graichen, M.Sc., Otto-Friedrich-University Bamberg
- Principal Investigator: Anni Pakarinen, PhD, University of Turku
- Principal Investigator: Carlo Stingl, M.Sc., Otto-Friedrich-University Bamberg
- Principal Investigator: Riitta Mieronkoski, University of Turku
- Principal Investigator: Glenda Dangis, University of Turku
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- Hand hygiene kindergarten
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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