NCT05328128

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 18, 2022

Last Update Submit

April 12, 2022

Conditions

Toilet Training

Keywords

Toilet trainingSocial-emotional developmentChild

Outcome Measures

Primary Outcomes (1)

  • Toilet training completion age

    It was defined as the age at which bladder and bowel control were fully achieved.

    6 months

Study Arms (2)

Study Group

EXPERIMENTAL

Children and families included in the study group were directed to the child development unit to receive toilet training.

Behavioral: Toilet training

Control Group

NO INTERVENTION

The control group consisted of families who wanted to manage toilet training process themselves.

Interventions

Toilet trainingBEHAVIORAL

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

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • not having received toilet training
  • age of the child between 18-36 months
  • normal social-emotional development
  • no known chronic disease

You may not qualify if:

  • having received toilet training
  • the child's age is outside the range of 18-36 months
  • abnormal social-emotional development
  • presence of chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Ankara City Hospital, Children's Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Study Officials

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2022

First Posted

April 14, 2022

Study Start

January 1, 2019

Primary Completion

April 1, 2019

Study Completion

December 31, 2019

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)