- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05328128
Investigation of the Effect of Toilet Training Given to Children
April 12, 2022 updated by: Hamdullah Cem Kaçmaz, Ankara City Hospital Bilkent
Investigation of the Effect of Toilet Training Given to Children Who Have no Problems in Their Social-emotional Development on the Process of Acquiring Toilet Habits
In the study, it was aimed to examine the factors affecting the toilet training of children aged 18-36 months who have no problems in social-emotional development and the effect of professional support on the toilet training process.
Study Overview
Detailed Description
Toilet training studies in Turkey and analyzes of bladder, bowel control and training completion times in these studies are limited.
In this study, training processes were examined separately, and the factors that were not studied frequently until today were investigated.
Also the effects of the professional support provided to children who did not have problems in social-emotional development on the process were examined.
Study Type
Interventional
Enrollment (Actual)
214
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cankaya
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Ankara, Cankaya, Turkey, 06800
- University of Health Sciences, Ankara City Hospital, Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- not having received toilet training
- age of the child between 18-36 months
- normal social-emotional development
- no known chronic disease
Exclusion Criteria:
- having received toilet training
- the child's age is outside the range of 18-36 months
- abnormal social-emotional development
- presence of chronic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Group
Children and families included in the study group were directed to the child development unit to receive toilet training.
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As the training model, Brazelton's child-oriented toilet training method was taken as the basis in study group.
In addition, literature studies on toilet training in Turkey were scanned and the final form of training to be given to mothers was created.
In the control group, families manage training process themselves.
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No Intervention: Control Group
The control group consisted of families who wanted to manage toilet training process themselves.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toilet training completion age
Time Frame: 6 months
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It was defined as the age at which bladder and bowel control were fully achieved.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Aysun Kara Uzun, University of Health Sciences, Ankara City Hospital, Children's Hospital
- Study Chair: Sevilay Yildiz Akkus, University of Health Sciences, Ankara City Hospital, Children's Hospital
- Study Chair: Bahar Cuhaci Cakir, Gazi University
- Study Chair: Eda Ozaydin, University of Health Sciences, Ankara City Hospital, Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
March 18, 2022
First Submitted That Met QC Criteria
April 12, 2022
First Posted (Actual)
April 14, 2022
Study Record Updates
Last Update Posted (Actual)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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