NCT06199804

Brief Summary

The present study aims to evaluate the effectiveness of toy hygiene education given to mothers of hospitalized children on their knowledge and practices, as well as the cleanliness of toy surfaces.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

January 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

December 27, 2023

Last Update Submit

January 9, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sociodemographic Questionnaire

    Demographic data for the mother and her sick child were questioned in the form prepared by the researchers in line with the literature (Avila-Aguero et al. 2004; Merriman et al. 2002, Deshpande et al. 2020). As variables related to the mother, age, family type, number of children, education level, employment status, perception of economic situation, place of residence and the status of receiving information about toy hygiene were questioned. For the child; It was composed of questions asking age, gender, medical diagnosis, presence of chronic disease, hospitalization, room type, and hospitalization experience.

    First measurement-First day of hospitalization

  • Toy Hygiene Information Form

    The toy hygiene information form, prepared by the researchers in line with the literature (Avila-Aguero et al. 2004; Yokoe et al. 2009), was composed of two parts. In the first part, the types of toys that parents prefer to buy for their children, their preference for buying cleanable toys, the situation of cleaning toys before bringing them to the hospital, their practices to ensure toy hygiene in the hospital environment, and the difficulties they experience in ensuring toy hygiene in the hospital environment are questioned. In the second part of the form, a knowledge test consisting of 31 items was prepared to determine the knowledge level of mothers regarding toy hygiene. The second part of the form is answered as true or false. A high score from the knowledge test is interpreted as a high level of "toy hygiene knowledge".

    First measurement-First day of hospitalization

  • Toy Surface Cleaning Level Record Form

    This form was created by researchers to record the level of surface cleanliness by taking a swab from the toy surface with the 3M™ Clean-Trace™ ATP device before and after the training.

    First measurement-First day of hospitalization

Secondary Outcomes (2)

  • Toy Hygiene Information Form

    Second measurement-Third day of hospitalization

  • Toy Surface Cleaning Level Record Form

    Second measurement-Third day of hospitalization

Study Arms (2)

Experimental Group

EXPERIMENTAL

A program was created to be given to the mothers in the experimental group in line with the content of the "Toy Hygiene Guide Book" prepared by the researchers.

Behavioral: Toy Hygiene Training

Control Group

NO INTERVENTION

The researcher did not apply anything other than the clinical routine to the control group during the first three days of hospitalization.

Interventions

The training was given to the mothers in 2 sessions (morning and afternoon), each lasting approximately 30 minutes, accompanied by the Toy Hygiene Guide. The sessions were presented face to face in the mother's room in the form of explaining, showing, question and answer and power point, at a time convenient for the mother and the child, outside the morning and afternoon treatment and care hours. After the first session was completed, an appointment was made with the mother for the afternoon session. In the second session, the information in the book that was not given in the first session was presented to the mothers face to face in the mother's room, outside the treatment and care hours, at a time convenient for the mother and the child. After the training was completed, a final five-minute discussion was held with the mothers in the form of a general question and answer session. The training book was given to the mothers in the experimental group on the first day.

Experimental Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince mothers stayed with their children, only mothers were included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers with children in the play (1-3) and preschool (4-6) periods
  • Those who keep toys (plastic, metal, wooden, technological) with their children
  • Mothers who are always with their children as companions
  • Mothers whose children receive inpatient treatment for at least 3 days

You may not qualify if:

  • Mother has hearing, vision or mental problems
  • The mother has been diagnosed with OCD (Obsessive Compulsive Disorder) or has an obsession with cleaning.
  • Not being able to speak Turkish
  • Being under 18 years of age
  • Do not place the child in isolation (contact isolation, droplet isolation, respiratory isolation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Related Publications (4)

  • Deshpande A, Dunn AN, Fox J, Cadnum JL, Mana TSC, Jencson A, Fraser TG, Donskey CJ, Gordon SM. Monitoring the effectiveness of daily cleaning practices in an intensive care unit (ICU) setting using an adenosine triphosphate (ATP) bioluminescence assay. Am J Infect Control. 2020 Jul;48(7):757-760. doi: 10.1016/j.ajic.2019.11.031. Epub 2019 Dec 26.

    PMID: 31883729BACKGROUND
  • Yokoe D, Casper C, Dubberke E, Lee G, Munoz P, Palmore T, Sepkowitz K, Young JA, Donnelly JP; Center for International Blood and Marrow Transplant Research; National Marrow Donor Program; European Blood and Marrow Transplant Group; American Society of Blood and Marrow Transplantation; Canadian Blood and Marrow Transplant Group; Infectious Disease Society of America; Society for Healthcare Epidemiology of America; Association of Medical Microbiology and Infectious Diseases Canada; Centers for Disease Control and Prevention. Infection prevention and control in health-care facilities in which hematopoietic cell transplant recipients are treated. Bone Marrow Transplant. 2009 Oct;44(8):495-507. doi: 10.1038/bmt.2009.261. No abstract available.

    PMID: 19861984BACKGROUND
  • Avila-Aguero ML, German G, Paris MM, Herrera JF; Safe Toys Study Group. Toys in a pediatric hospital: are they a bacterial source? Am J Infect Control. 2004 Aug;32(5):287-90. doi: 10.1016/j.ajic.2003.10.018.

  • Merriman E, Corwin P, Ikram R. Toys are a potential source of cross-infection in general practitioners' waiting rooms. Br J Gen Pract. 2002 Feb;52(475):138-40.

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sibel Küçükoğlu, Prof

    Selcuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The population of the research consisted of mothers with children aged 1-3 and 4-6 who were treated as inpatients in the pediatric clinics of a public hospital in the central Anatolia region of Turkey between January and August 2023. Inclusion Criteria; * Mothers with children in the play (1-3) and preschool (4-6) periods * Those who keep toys (plastic, metal, wooden, technological) with their children * Mothers who are always with their children as companions * Mothers whose children receive inpatient treatment for at least 3 days Exclusion Criteria; * Mother has hearing, vision or mental problems * The mother has been diagnosed with OCD (Obsessive Compulsive Disorder) or has an obsession with cleaning. * Not being able to speak Turkish * Being under 18 years of age * Do not place the child in isolation (contact isolation, droplet isolation, respiratory isolation).
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: In this study, stratified randomization method was used to determine the intervention and control groups. It is emphasized in the literature that the variables that affect children's compliance with hospital rules are affected by the education level of the mother and the age of the child. Therefore, to ensure homogeneity in the groups, they were stratified as the mother's education level (primary school, high school, university) and age group (1-3 and 4-6). In the study, randomizer.org was used to select 6-block A and B block combinations. Eligible participants were randomly assigned to experimental and control groups using the permuted block randomization method on a 1:1 basis.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Faculty of Nursing

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 10, 2024

Study Start

January 15, 2023

Primary Completion

August 15, 2023

Study Completion

December 13, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

It will be shared after the article is published

Locations