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

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

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

Study Overview

• Status: Recruiting
• Conditions: Constipation; Children; Functional Constipation; Therapeutic Touch; Infants
• Intervention / Treatment: Behavioral: Therapeutic Touch

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Selda Ateş Beşirik, PhD.; Phone Number: +905076228189; Email: seldaates07@gmail.com
• Study Contact Backup: Name: Emine Geçkil, Professor; Phone Number: +905076228189; Email: seldaates07@gmail.com

Study Locations

• Turkey
  • Bucak
    • Burdur, Bucak, Turkey, 15030
      • Recruiting
      • Burdur Bucak State Hospital
      • Contact: Selda Ateş Beşirik, PhD.; Phone Number: +905076228189; Email: seldaates07@gmail.com
      • Principal Investigator: Selda Ateş Beşirik, PhD.
      • Sub-Investigator: Emine Geçkil, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Therapeutic Touch will be applied to infants for three consecutive days, once a day, ten minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of three times in one week.	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.
No Intervention: Control group; The therapeutic touch will not be applied to the control group infants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Results Follow-up Form	Weekly Bowel sounds (movements) (min)	In four weeks
Primary Results Follow-up Form	Number of stools and Stool density	In four weeks
Primary Results Follow-up Form	Height (cm)	In four weeks
Primary Results Follow-up Form	Weight (g)	In four weeks
Primary Results Follow-up Form	BMI	In four weeks
Primary Results Follow-up Form	Abdominal circumference (cm)	In four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Burdur Mehmet Akif Ersoy University
• Investigators: Study Director: Emine Geçkil, Professor, Necmettin Erbakan University; Principal Investigator: Selda Ateş Beşirik, PhD., Burdur Mehmet Akif Ersoy University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Children; Infants; Therapeutic Touch; Functional Constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 2023/435

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No