Function ConstipationNCT07233772
Effect of Motivational Interviewing Training on Mothers' Anxiety and Children's Constipation
A study testing Motivational Interview-Based Constipation Education Program in people with Function Constipation and Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Function Constipation, Anxiety
- What is being tested?
- Motivational Interview-Based Constipation Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2025to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mother of a 4-6 year old child attending preschool/kindergarten with functional constipation diagnosed per Rome IV criteria
Who cannot join
- Mothers of children with congenital anomalies or chronic gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Preschools Affiliated with the Ministry of National Education
Karaman, Centre, 70200
About this study
Official 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
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.
Read the 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.
- Conditions
- Function Constipation, Anxiety
- Being tested
- Motivational Interview-Based Constipation Education Program
- Keywords
- children, functional constipation symptoms, education program, maternal anxiety, motivational interviewing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview-Based Constipation Education ProgramOther
Structured educational sessions delivered to mothers using motivational interviewing techniques, aiming to reduce maternal anxiety and improve children's constipation symptoms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Motivational Interview-Based Constipation Education Program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defecation Frequency
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.
Measured: 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)
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.
Measured: From baseline to the end of the fourth week, with assessments conducted at the end of the first, second, third, and fourth weeks.
Secondary outcomes (1)
Trait Anxiety Inventory (STAI-T)
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.
Measured: From baseline to the end of the fourth week, with assessments conducted at the end of the first and fourth weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start3 Nov 2025
- Primary completion24 Nov 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Function ConstipationStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment model. Participants will be randomly assigned to either the intervention group, which will receive a motivational interview-based constipation education program, or the control group, which will receive no intervention. Randomization will be performed using a block randomization method to ensure balanced allocation between groups. Outcomes will be compared at the end of the intervention period
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Koçyiğit Gültepe, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233772
- Sponsor's protocol ID
- necmettineu-koçyiğitgültepe-01
- Status last verified
- Apr 2026
- First submitted
- 29 Sep 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD) in order to ensure the protection of participants' personal information and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07233772
- Acronym / sponsor ID
- necmettineu-koçyiğitgültepe-01
- Conditions
- Function Constipation, Anxiety
- Keywords
- children, functional constipation symptoms, education program, maternal anxiety, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment model. Participants will be randomly assigned to either the intervention group, which will receive a motivational interview-based constipation education program, or the control group, which will receive no intervention. Randomization will be performed using a block randomization method to ensure balanced allocation between groups. Outcomes will be compared at the end of the intervention period
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Motivational Interview-Based Constipation Education ProgramFirst, 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mother of a 4-6 year old child attending preschool/kindergarten with functional constipation diagnosed per Rome IV criteria
Key exclusion criteria (1 listed)
- Mothers of children with congenital anomalies or chronic gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interview-Based Constipation Education ProgramStructured educational sessions delivered to mothers using motivational interviewing techniques, aiming to reduce maternal anxiety and improve children's constipation symptoms | Other | Intervention Group |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD) in order to ensure the protection of participants' personal information and confidentiality.
Related trials for Function Constipation
RecruitingPhase 2
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
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Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview-Based Constipation Education Program in people with Function Constipation and Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.