- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06199804
Toy Hygiene Education For Hospitalized Mothers
Determining The Effectiveness of Toy Hygiene Education For Hospitalized Mothers: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selcuklu
-
Konya, Selcuklu, Turkey, 42100
- Selcuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
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.
|
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.
|
|
No Intervention: Control Group
The researcher did not apply anything other than the clinical routine to the control group during the first three days of hospitalization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
First measurement-First day of hospitalization
|
|
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".
|
First measurement-First day of hospitalization
|
|
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.
|
First measurement-First day of hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Toy Hygiene Information Form
Time Frame: Second measurement-Third 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". Only the second part of the form was remeasured. |
Second measurement-Third day of hospitalization
|
|
Toy Surface Cleaning Level Record Form
Time Frame: Second measurement-Third 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.
|
Second measurement-Third day of hospitalization
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: sibel küçükoğlu, Prof, Selcuk University
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SelcukUnı4235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Children, Only
-
Riphah International UniversityCompletedChildren, OnlyPakistan
-
Hospital Authority, Hong KongCompleted
-
Riphah International UniversityRecruiting
-
Semmelweis UniversityRecruitingAnesthesia | Children, OnlyHungary
-
American University of Beirut Medical CenterCompletedAnesthesia | Children, OnlyLebanon
-
University of SaskatchewanCompleted
-
T.C. ORDU ÜNİVERSİTESİUnknownAdolescent | Children, Only
-
St. Justine's HospitalCompletedChildren, Only | Anesthesia; ReactionCanada
-
McMaster UniversityHamilton-Wentworth Catholic District School Board; Start2FinishCompletedPhysical Activity | Children, OnlyCanada
-
Utah State UniversityUtah Agriculture Experiment StationCompletedChildren, Only | Raman SpectroscopyUnited States
Clinical Trials on Toy Hygiene Training
-
University of ConnecticutEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHemiplegic Cerebral PalsyUnited States
-
Istanbul Sultanbeyli State HospitalCompleted
-
Istanbul University - CerrahpasaThe Scientific and Technological Research Council of TurkeyRecruitingHospital InfectionTurkey
-
Telethon Kids InstituteUniversity of Sao Paulo; Hospital das Clínicas de São Paulo - SP; Child and Adolescent...RecruitingPerioperative AnxietyAustralia, Brazil
-
Ege UniversityCompletedAnxiety | Fear | Therapeutic PlayTurkey
-
Marmara UniversityActive, not recruiting
-
Saglik Bilimleri UniversitesiCompletedWomen in the Menopausal PeriodTurkey (Türkiye)
-
University of Toledo Health Science CampusWithdrawnBreast Cancer | Sleep HygieneUnited States
-
Inonu UniversityCompletedGenital Hygiene | Genital Hygiene Behaviors | Self-care AgencyTurkey
-
University College, LondonUniversity of California, Santa Cruz; Anna Freud National Centre for Children... and other collaboratorsUnknown