ClinicalTrials.Veeva

Menu

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

B

Burdur Mehmet Akif Ersoy University

Status

Completed

Conditions

Functional Constipation
Therapeutic Touch
Children
Infants
Constipation

Treatments

Behavioral: Therapeutic Touch

Study type

Interventional

Funder types

Other

Identifiers

NCT06353841
2023/435

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

6 to 24 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Intervention Group
Experimental group
Description:
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.
Treatment:
Behavioral: Therapeutic Touch
Control group
No Intervention group
Description:
The therapeutic touch will not be applied to the control group infants.

Trial contacts and locations

1

Loading...

Central trial contact

Selda Ateş Beşirik, PhD.; Emine Geçkil, Professor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems