Constipation Clinical Trial
Official title:
The Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children: A Randomized Controlled Study
NCT number | NCT06353841 |
Other study ID # | 2023/435 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2023 |
Est. completion date | December 31, 2024 |
The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 24 Months |
Eligibility | Inclusion Criteria: - The infant is between 6-24 months, - The infant was born at term, - Birth weight between 2500-4500 g, - Must have been diagnosed with functional constipation by the physician according to ROMA IV criteria, - Mothers' ability to read, write and speak Turkish, - Parent's willingness to participate in the research. Exclusion Criteria: - The infant has a congenital anomaly, - The infant has any chronic disease, - Having a secondary disease that causes constipation such as cow's milk allergy, celiac disease, hypercalcemia and hypothyroidism, neurological diseases,Children with any organic or metabolic diseases - The parent has a verbal and written communication barrier. |
Country | Name | City | State |
---|---|---|---|
Turkey | Burdur Bucak State Hospital | Burdur | Bucak |
Lead Sponsor | Collaborator |
---|---|
Burdur Mehmet Akif Ersoy University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Results Follow-up Form | Weekly Bowel sounds (movements) (min) | In four weeks | |
Primary | Primary Results Follow-up Form | Number of stools and Stool density | In four weeks | |
Primary | Primary Results Follow-up Form | Height (cm) | In four weeks | |
Primary | Primary Results Follow-up Form | Weight (g) | In four weeks | |
Primary | Primary Results Follow-up Form | BMI | In four weeks | |
Primary | Primary Results Follow-up Form | Abdominal circumference (cm) | In four weeks | |
Secondary | Bristol Stool Scale | In this scoring system, stool hardness is evaluated from the hardest to the softest, according to the adhesion and cracking characteristics of the stool.
In this scoring system, stool hardness is from the hardest to the softest, according to the adhesion and cracking characteristics of the stool; is divided into seven classes: hard scattered tubers like hazelnuts:Type 1, sausage-shaped but lumpy:Type 2, like a sausage but with cracks on the surface:Type 3, smooth and soft like a sausage or snake:Type 4, soft grains with obvious cuts on the edges:Type 5, mushy stool with irregular edges and fluid pieces:Type 6, watery, with no solid pieces, and completely liquid:Type 7. Type 1 and Type 2 are difficult defecation patterns and suggest the presence of constipation, Type 3, Type 4 and Type 5 indicate normal defecation, and Type 6 and Type 7 suggest diarrhea. |
In four weeks |
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