NCT05395988

Brief 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. Aim of the study is to better understand behavior change of young children.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

March 25, 2022

Last Update Submit

May 23, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    up to 3 months

Secondary Outcomes (1)

  • Sickness days of children (as recorded by kindergarten management)

    Up to one year

Study Arms (4)

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.

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.

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.

Device: Digital hand washing instructionsDevice: Digital hand washing reward

Interventions

Tablet displaying animated hand washing instructions

Instruction groupReward plus instruction-only group

Tablet displaying animated hand washing instructions and animated animals as reward

Reward groupReward plus instruction-only group

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children attending kindergarten

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Turku

Turku, 20520, Finland

Location

Otto-Friedrich-University Bamberg

Bamberg, 96047, Germany

Location

Related Publications (1)

  • 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.

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2022

First Posted

May 27, 2022

Study Start

March 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations