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临床试验/NCT07233772
NCT07233772Enrolling By Invitation不适用

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

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
1
主要终点
Defecation Frequency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Mother of a 4-6 year old child attending preschool/kindergarten with functional constipation diagnosed per Rome IV criteria

排除标准

  • •Mothers of children with congenital anomalies or chronic gastrointestinal disease

研究组 & 干预措施

Intervention Group

Experimental

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.

干预措施: Motivational Interview-Based Constipation Education Program (Other)

Control Group

No Intervention

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.

结局指标

主要结局

Defecation Frequency

时间窗: 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.

Bristol Stool Form Scale (BSFS)

时间窗: 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.

次要结局

  • Trait Anxiety Inventory (STAI-T)(From baseline to the end of the fourth week, with assessments conducted at the end of the first and fourth weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kübra Koçyiğit Gültepe

PhD Candidate

Necmettin Erbakan University

研究点 (1)

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