Hand HygieneNCT05395988
Hand Hygiene of Kindergarten Children
A study testing Digital hand washing instructions and Digital hand washing reward in people with Hand Hygiene and Hand Washing, run by Otto-Friedrich-University Bamberg at 2 sites in 2 countries.
Trial summary
Randomized controlled trial to further assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens will see live instructions and feedback on their hand washing activity in reals-time / while washing hands. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene, Hand Washing
- What is being tested?
- Digital hand washing instructions and Digital hand washing reward
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2022to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children attending kindergarten
Who cannot join
- none
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Hand Hygiene of Kindergarten Children: Understanding the Effect of Live Feedback on Hand Washing Behavior, Self-Efficacy and Motivation of Young Children
Randomized controlled trial to further assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens will see live instructions and feedback on their hand washing activity in reals-time / while washing hands. Aim of the study is to better understand behavior change of young children.
- Conditions
- Hand Hygiene, Hand Washing
- Being tested
- Digital hand washing instructions, Digital hand washing reward
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital hand washing instructionsDevice
Tablet displaying animated hand washing instructions
Digital hand washing rewardDevice
Tablet displaying animated hand washing instructions and animated animals as reward
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group receives no screen next to the sink. |
| Instruction group | Experimental | 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. Receives: Device: Digital hand washing instructions |
| Reward group | Experimental | 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. Receives: Device: Digital hand washing reward |
| Reward plus instruction-only group | Experimental | 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. Receives: Device: Digital hand washing instructions; Device: Digital hand washing reward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handwashing motivation of children (measured as soaping time by digital system).
Motivation of children, measured as soaping time (activity level) by digital system. Activity level is used as a proxy for motivation.
Measured: up to 3 months
Handwashing motivation of children (investigated with observation questionnaire for children in kindergarten)
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.
Measured: up to 3 months
Self-efficacy of children (investigated with interviews with children)
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.
Measured: up to 3 months
Self-efficacy of children (investigated with interviews with staff)
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.
Measured: up to 3 months
Secondary outcomes (1)
Sickness days of children (as recorded by kindergarten management)
Sickness days of children, recorded by kindergarten management on a daily basis.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Mar 2022
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand HygieneStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otto-Friedrich-University Bamberg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku
- Responsible party
- Sponsor
- Investigators
- Sanna Salanterä, Prof. Dr., Principal investigator, University of TurkuJoanna Graichen, M.Sc., Principal investigator, Otto-Friedrich-University BambergAnni Pakarinen, PhD, Principal investigator, University of TurkuCarlo Stingl, M.Sc., Principal investigator, Otto-Friedrich-University BambergRiitta Mieronkoski, Principal investigator, University of TurkuGlenda Dangis, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395988
- Sponsor's protocol ID
- Hand hygiene kindergarten
- Status last verified
- May 2022
- First submitted
- 25 Mar 2022
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dangis G, Terho K, Graichen J, Gunther SA, Rosio R, Salantera S, Staake T, Stingl C, Pakarinen A. Hand hygiene of kindergarten children-Understanding the effect of live feedback on handwashing behaviour, self-efficacy, and motivation of young children: Protocol for a multi-arm cluster randomized controlled trial. PLoS One. 2023 Jan 24;18(1):e0280686. doi: 10.1371/journal.pone.0280686. eCollection 2023.
PubMed 36693062
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Hygiene of Kindergarten Children: Understanding the Effect of Live Feedback on Hand Washing Behavior, Self-Efficacy and Motivation of Young Children
- ClinicalTrials.gov ID
- NCT05395988
- Acronym / sponsor ID
- Hand hygiene kindergarten
- Conditions
- Hand Hygiene, Hand Washing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Otto-Friedrich-University BambergUniversity, hospital or other
- Collaborators
- University of Turku
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 27 May 2022 (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.
Randomized controlled trial to further assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens will see live instructions and feedback on their hand washing activity in reals-time / while washing hands. Aim of the study is to better understand behavior change of young children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group receives no screen next to the sink. |
| Instruction group | Experimental | Device: Digital hand washing instructionsThe 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. |
| Reward group | Experimental | Device: Digital hand washing rewardThe 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. |
| Reward plus instruction-only group | Experimental | Device: Digital hand washing instructions, Device: Digital hand washing rewardThe 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. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children attending kindergarten
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Digital hand washing instructionsTablet displaying animated hand washing instructions | Device | Instruction group, Reward plus instruction-only group |
| Digital hand washing rewardTablet displaying animated hand washing instructions and animated animals as reward | Device | Reward group, Reward plus instruction-only group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Sickness days of children (as recorded by kindergarten management)
Time frame: Up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 36693062Dangis G, Terho K, Graichen J, Gunther SA, Rosio R, Salantera S, Staake T, Stingl C, Pakarinen A. Hand hygiene of kindergarten children-Understanding the effect of live feedback on handwashing behaviour, self-efficacy, and motivation of young children: Protocol for a multi-arm cluster randomized controlled trial. PLoS One. 2023 Jan 24;18(1):e0280686. doi: 10.1371/journal.pone.0280686. eCollection 2023.
Related trials for Hand Hygiene
Not yet recruiting
Effect of Digital Method-Based Hand Hygiene Education on Handwashing Skills in Primary School Students
Hand Hygiene, School Health, Primary School Students, Health Education
Recruiting
Tailor VHA HH Bundle for Acute Mental Health Care
Hand Hygiene Compliance
Not yet recruitingObservational study
Hand Hygiene Compliance and Bacterial Colonization on Personal Belongings
Intensive Care Nurses, Bacterial Colonization
Not yet recruiting
Fluorescent Hand Hygiene Training and Long-Term Effects in First-Year Nursing Students
Hand Hygiene Compliance, Hand Hygiene Effectiveness
Recruiting
Effectiveness of VR on the Sustainability of Hand Hygiene Compliance: School-based RCT With 10-month Follow-up
Hand, Hygiene Practices and Knowledge
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. This study is not recruiting at the moment.
Sanna Salanterä, Prof. Dr. principal investigator
University of Turku
Joanna Graichen, M.Sc. principal investigator
Otto-Friedrich-University Bamberg
Anni Pakarinen, PhD principal investigator
University of Turku
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital hand washing instructions and Digital hand washing reward in people with Hand Hygiene and Hand Washing, run by Otto-Friedrich-University Bamberg at 2 sites in 2 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handwashing motivation of children (measured as soaping time by digital system). (time frame: up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05395988, which also lists 1 linked publication.
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 27 May 2022.