Toilet TrainingNCT05328128
Investigation of the Effect of Toilet Training Given to Children
A study testing Toilet training in people with Toilet Training, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Toilet Training
- What is being tested?
- Toilet training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- not having received toilet training
- age of the child between 18-36 months
- normal social-emotional development
- no known chronic disease
Who cannot join
- having received toilet training
- the child's age is outside the range of 18-36 months
- abnormal social-emotional development
- presence of chronic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Ankara City Hospital, Children's Hospital
Ankara, Cankaya, 06800
About this study
Official title: 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.
Read the 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.
- Conditions
- Toilet Training
- Being tested
- Toilet training
- Keywords
- Toilet training, Social-emotional development, Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toilet trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Children and families included in the study group were directed to the child development unit to receive toilet training. Receives: Behavioral: Toilet training |
| Control Group | No intervention | The control group consisted of families who wanted to manage toilet training process themselves. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toilet training completion age
It was defined as the age at which bladder and bowel control were fully achieved.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Jan 2019
- Primary completion1 Apr 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toilet TrainingStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdullah Cem Kaçmaz, Ankara City Hospital Bilkent
- Investigators
- Aysun Kara Uzun, Study chair, University of Health Sciences, Ankara City Hospital, Children's HospitalSevilay Yildiz Akkus, Study chair, University of Health Sciences, Ankara City Hospital, Children's HospitalBahar Cuhaci Cakir, Study chair, Gazi UniversityEda Ozaydin, Study chair, University of Health Sciences, Ankara City Hospital, Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328128
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2022
- First submitted
- 18 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05328128
- Acronym / sponsor ID
- 1
- Conditions
- Toilet Training
- Keywords
- Toilet training, Social-emotional development, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Apr 2022 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: Toilet trainingChildren and families included in the study group were directed to the child development unit to receive toilet training. |
| Control Group | No intervention | –The control group consisted of families who wanted to manage toilet training process themselves. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- not having received toilet training
- age of the child between 18-36 months
- normal social-emotional development
- no known chronic disease
Key exclusion criteria (4 listed)
- having received toilet training
- the child's age is outside the range of 18-36 months
- abnormal social-emotional development
- presence of chronic disease
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 |
|---|---|---|
| Toilet trainingAs 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. | Behavioural | Study Group |
Primary outcome
Toilet training completion age
Time frame: 6 months
It was defined as the age at which bladder and bowel control were fully achieved.
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 14 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Toilet Training
Active, not recruiting
Bowel And Bladder Function in Infant Toilet Training
Infantile Colic, Constipation - Functional
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.
Aysun Kara Uzun study chair
University of Health Sciences, Ankara City Hospital, Children's Hospital
Sevilay Yildiz Akkus study chair
University of Health Sciences, Ankara City Hospital, Children's Hospital
Bahar Cuhaci Cakir study chair
Gazi 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 Toilet training in people with Toilet Training, run by Ankara City Hospital Bilkent 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 4 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 14 Apr 2022. 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?
Toilet training completion age (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2022.