Clinical trial NCT06353841: Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children
Official title: The Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Therapeutic Touch
Infants
Children
Constipation
Keywords: Therapeutic Touch
Functional Constipation
Infants
Children
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Results Follow-up Form
timeFrame: In four weeks
measure: Primary Results Follow-up Form
timeFrame: In four weeks
measure: Primary Results Follow-up Form
timeFrame: In four weeks
measure: Primary Results Follow-up Form
timeFrame: In four weeks
measure: Primary Results Follow-up Form
timeFrame: In four weeks
Secondary outcomes:
measure: Bristol Stool Scale
timeFrame: In four weeks
measure: Constipation discomfort
timeFrame: In four weeks
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Bucak State Hospital
state: Bucak
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Selda Ateş Beşirik, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: Emine Geçkil, Professor
role: STUDY_DIRECTOR
References: