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Completed

NCT Number: NCT07233772

Effect of Motivational Interviewing Training on Mothers' Anxiety and Children's Constipation

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.

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Key information

Conditions

Function Constipation Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Preschools Affiliated with the Ministry of National Education

Karaman, Centre, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interview-Based Constipation Education Program

Other

Structured educational sessions delivered to mothers using motivational interviewing techniques, aiming to reduce maternal anxiety and improve children's constipation symptoms

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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