Children, OnlyNCT06199804
Toy Hygiene Education For Hospitalized Mothers
A study testing Toy Hygiene Training in people with Children, Only and Educational Problems, run by Sibel Küçükoğlu at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Children, Only, Educational Problems, Hospital Infection
- What is being tested?
- Toy Hygiene Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 13 Dec 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining The Effectiveness of Toy Hygiene Education For Hospitalized Mothers: Randomized Controlled Trial
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.
Read the detailed description
While studies show that toys contain significant amounts of pathogenic microorganisms and may be effective in the spread of hospital-acquired infections, it appears that the literature and hospital practices on the disinfection of these toys are quite limited. Additionally, there is no routine practice to ensure toy hygiene in most health institutions. Therefore, in order to prevent the transfer of infectious agents through toys, policies and guidelines regarding toy cleaning methods and frequency should be established in hospitals. At the same time, families should be educated about the fact that toys can be a source of infection, and correct behavioral changes regarding toy hygiene should be created. When the literature was examined, it was determined that there were no routine hygiene practices regarding the cleaning of toys in children's clinics in Turkey. For this reason, the study will examine the effect of the toy hygiene education created by the researchers on the knowledge levels and practices of mothers and the surface cleaning of toys. It is thought that the results of the study will be a basis for creating clinical guidelines.
- Conditions
- Children, Only, Educational Problems, Hospital Infection
- Being tested
- Toy Hygiene Training
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toy Hygiene TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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.
Measured: First measurement-First day of hospitalization
Secondary outcomes (2)
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".
Only the second part of the form was remeasured.
Measured: Second measurement-Third 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.
Measured: Second measurement-Third day of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Jan 2023
- Primary completion15 Aug 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Children, OnlyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel Küçükoğlu
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor-investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Küçükoğlu, Prof, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199804
- Sponsor's protocol ID
- SelcukUnı4235
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published
Publications
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.
PubMed 31883729Yokoe 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.
PubMed 19861984Avila-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.
PubMed 15292894Merriman 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.
PubMed 11885823Aksay O, Kucukoglu S. Improving toy hygiene in pediatric hospital settings through maternal education: A randomized controlled study. Am J Infect Control. 2026 Mar;54(3):287-294. doi: 10.1016/j.ajic.2025.10.011. Epub 2025 Oct 25.
PubMed 41761745
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining The Effectiveness of Toy Hygiene Education For Hospitalized Mothers: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06199804
- Acronym / sponsor ID
- SelcukUnı4235
- Conditions
- Children, Only, Educational Problems, Hospital Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sibel KüçükoğluUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 10 Jan 2024 (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.
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.
Detailed description
While studies show that toys contain significant amounts of pathogenic microorganisms and may be effective in the spread of hospital-acquired infections, it appears that the literature and hospital practices on the disinfection of these toys are quite limited. Additionally, there is no routine practice to ensure toy hygiene in most health institutions. Therefore, in order to prevent the transfer of infectious agents through toys, policies and guidelines regarding toy cleaning methods and frequency should be established in hospitals. At the same time, families should be educated about the fact that toys can be a source of infection, and correct behavioral changes regarding toy hygiene should be created. When the literature was examined, it was determined that there were no routine hygiene practices regarding the cleaning of toys in children's clinics in Turkey. For this reason, the study will examine the effect of the toy hygiene education created by the researchers on the knowledge levels and practices of mothers and the surface cleaning of toys. It is thought that the results of the study will be a basis for creating clinical guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Toy Hygiene TrainingA 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| Toy Hygiene TrainingThe 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. | Behavioural | Experimental Group |
Primary outcome
Sociodemographic Questionnaire
Time frame: First measurement-First day of hospitalization
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.
Toy Hygiene Information Form
Time frame: First measurement-First day of hospitalization
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".
Toy Surface Cleaning Level Record Form
Time frame: First measurement-First day of hospitalization
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.
2 secondary outcomes
Toy Hygiene Information Form
Time frame: Second measurement-Third day of hospitalization
Toy Surface Cleaning Level Record Form
Time frame: Second measurement-Third day of hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 31883729Deshpande 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.
- Background: PubMed 19861984Yokoe 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.
- Results publication: PubMed 15292894Avila-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.
- Results publication: PubMed 11885823Merriman 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.
- Derived from this study: PubMed 41761745Aksay O, Kucukoglu S. Improving toy hygiene in pediatric hospital settings through maternal education: A randomized controlled study. Am J Infect Control. 2026 Mar;54(3):287-294. doi: 10.1016/j.ajic.2025.10.011. Epub 2025 Oct 25.
- Individual participant dataSharing planned: No. It will be shared after the article is published
Related trials for Children, Only
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
Myopia, Myopia Progression
RecruitingPhase 2
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
High Grade Glioma, CNS Tumor
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.
Sibel Küçükoğlu, Prof study director
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toy Hygiene Training in people with Children, Only and Educational Problems, run by Sibel Küçükoğlu at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sociodemographic Questionnaire (time frame: First measurement-First day of hospitalization). The study lists 3 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 NCT06199804, which also lists 5 linked publications.
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 10 Jan 2024.