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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey (Türkiye)
    • Centre
      • Karaman, Centre, Turkey (Türkiye), 70200
        • Preschools Affiliated with the Ministry of National Education

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Motivational Interview-Based Constipation Education Program
Structured educational sessions delivered to mothers using motivational interviewing techniques, aiming to reduce maternal anxiety and improve children's constipation symptoms
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
From baseline to the end of the fourth week, with assessments conducted at the end of the first, second, third, and fourth weeks.
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.
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.
From baseline to the end of the fourth week, with assessments conducted at the end of the first, second, third, and fourth weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
From baseline to the end of the fourth week, with assessments conducted at the end of the first and fourth weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Necmettin Erbakan University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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