- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233772
Effect of Motivational Interviewing Training on Mothers' Anxiety and Children's Constipation
April 6, 2026 updated by: Kübra Koçyiğit Gültepe, Necmettin Erbakan University
The Effect of a Motivational Interviewing-Based Constipation Training Program Given to Mothers on Maternal Anxiety Levels and Children's Constipation Symptoms: A Randomized Controlled Trial
Study Description (Brief Summary) Functional constipation (FC) is one of the most common gastrointestinal disorders in children.
It is a widespread bowel condition characterized by persistent difficulty, incomplete, or infrequent defecation without an organic, endocrine, or metabolic cause.
The prevalence of functional constipation in childhood ranges between 5% and 30%.
The preschool period is considered a risk factor for functional constipation, as children experience new beginnings and spend extended time away from home due to school.
During this period, mothers may experience increased anxiety.
The aim of this study is to reduce maternal anxiety and improve children's constipation symptoms through a constipation training program based on motivational interviewing delivered to mothers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Constipation is a common problem in children and can cause discomfort and anxiety for both the child and the family.
This study aims to help mothers manage their children's constipation symptoms through a training program based on motivational interviewing.
The program focuses on improving mothers' knowledge, motivation, and confidence in supporting their children's healthy bowel habits.
The study also examines whether this approach reduces mothers' anxiety levels.
The results are expected to contribute to better management of constipation in children and improved family well-being.
Study Type
Interventional
Enrollment (Actual)
50
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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-
Centre
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Karaman, Centre, Turkey (Türkiye), 70200
- Preschools Affiliated with the Ministry of National Education
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Mother of a 4-6 year old child attending preschool/kindergarten with functional constipation diagnosed per Rome IV criteria
Exclusion Criteria:
Mothers of children with congenital anomalies or chronic gastrointestinal 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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
First, the researcher will introduce herself and explain the purpose of the study to the participants.
Pre-tests will be administered to individuals who meet the inclusion criteria and agree to participate in the study.
At the pre-test stage, the Mother and Child Descriptive Information, Defecation Frequency, Bristol Stool Form Scale, and Trait Anxiety Inventory will be administered.
During follow-up assessments, Defecation Frequency and the Bristol Stool Form Scale will be used.
At the final follow-up, Defecation Frequency, the Bristol Stool Form Scale, and the Trait Anxiety Inventory will be administered.
A motivational interviewing-based intervention program will be implemented for the intervention group, and the follow-up period will last for one month.
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Structured educational sessions delivered to mothers using motivational interviewing techniques, aiming to reduce maternal anxiety and improve children's constipation symptoms
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No Intervention: Control Group
In the study, no intervention will be applied to the mothers in the control group.
As stated prior to the study, after the post-test data are collected, training will be planned for the participants in the control group and the training materials will be provided.
At the pre-test stage, the Mother and Child Descriptive Information Form, Defecation Frequency, Bristol Stool Form Scale, and Trait Anxiety Inventory will be administered.
During follow-ups, Defecation Frequency and the Bristol Stool Form Scale will be used.
At the post-test stage, Defecation Frequency, the Bristol Stool Form Scale, and the Trait Anxiety Inventory will be administered.
The follow-up period will last for one month.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Defecation Frequency
Time Frame: From baseline to the end of the fourth week, with assessments conducted at the end of the first, second, third, and fourth weeks.
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The number of defecations per week will be recorded to assess changes in bowel movement frequency during the study.
According to the Rome IV criteria, the weekly defecation frequency must be more than two times per week in order not to be classified as functional constipation.
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From baseline to the end of the fourth week, with assessments conducted at the end of the first, second, third, and fourth weeks.
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Bristol Stool Form Scale (BSFS)
Time Frame: From baseline to the end of the fourth week, with assessments conducted at the end of the first, second, third, and fourth weeks.
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Stool consistency will be assessed using the Bristol Stool Form Scale to evaluate changes over the intervention period.
Seven stool types are classified.
Types 1 and 2 (scores 1 and 2) indicate hard stools, which are associated with constipation; Types 3, 4, and 5 (scores 3, 4, and 5) represent normal stool forms; and Types 6 and 7 (scores 6 and 7) indicate loose or watery stools, typically observed in diarrhea.
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From baseline to the end of the fourth week, with assessments conducted at the end of the first, second, third, and fourth weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trait Anxiety Inventory (STAI-T)
Time Frame: From baseline to the end of the fourth week, with assessments conducted at the end of the first and fourth weeks.
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Maternal trait anxiety will be assessed using the Trait Anxiety Inventory Form.
The change in scores from baseline to post-intervention will be analyzed.
The total score obtained from the scale ranges from 20 to 80. Higher scores indicate higher levels of anxiety, whereas lower scores indicate lower levels of anxiety.
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From baseline to the end of the fourth week, with assessments conducted at the end of the first and fourth weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 3, 2025
Primary Completion (Actual)
November 24, 2025
Study Completion (Actual)
December 22, 2025
Study Registration Dates
First Submitted
September 29, 2025
First Submitted That Met QC Criteria
November 16, 2025
First Posted (Actual)
November 18, 2025
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 6, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- necmettineu-koçyiğitgültepe-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are no plans to share individual participant data (IPD) in order to ensure the protection of participants' personal information and confidentiality.
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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