Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children

Constipation Clinical Trial

Official title:

The Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353841
• Other study ID #: 2023/435
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Burdur Mehmet Akif Ersoy University
• Contact: Selda Ates Besirik, PhD.
• Phone: +905076228189
• Email: seldaates07[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children.

Description:

Functional constipation (FK) is a common functional gastrointestinal disorder that affects children's quality of life. The reported prevalence of functional constipation in infants and young children varies according to diagnostic criteria between studies. Laxatives and probiotics are commonly used to treat functional constipation. Therefore, treating constipation is very costly and there is not enough reliable data on this subject. When the literature is examined, the use of non-pharmacological methods to reduce, prevent and eliminate constipation has been increasing recently. When the studies were examined, studies using different methods were found. The main methods used in the care of children with constipation are; massage, aromatherapy, probiotics, laxatives, reflexology and acupuncture. The effect of therapeutic touch is thought to have positive results, especially in newborns, infants and children.Based on the studies conducted in line with the literature, this research has a randomized controlled experimental design to determine the effect of therapeutic touch applied to infants and children diagnosed with functional constipation according to Rome IV criteria on constipation. This study is a prospective, randomized and controlled trial. The study population consisted of infants and children aged 6 to 24 months. Sample of the study consisted of a total of 60 children who met the sample selection criteria and were selected via randomization method. Children were randomized into two groups: intervention gorup (n=30) and control group (n=30). Data were collected using the Interview and Observation Form, Primary Results Follow-up Form, and Bristol stool form scale.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Children
• Constipation
• Functional Constipation
• Infants
• Therapeutic Touch

Intervention

Behavioral:
• Therapeutic Touch
Therapeutic Touch will be applied to infants for 3 consecutive days, once a day, 10 minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of 3 times a week in four weeks.

Locations

Country	Name	City	State
Turkey	Burdur Bucak State Hospital	Burdur	Bucak

Sponsors (1)

Lead Sponsor	Collaborator
Burdur Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

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