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

NCT ID: NCT06353841

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2024-12-31

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.

Conditions

Functional Constipation; Therapeutic Touch; Infants; Children; Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapeutic Touch

Intervention Type: BEHAVIORAL

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.

Control group

The therapeutic touch will not be applied to the control group infants.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Burdur Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Selda Ateş Beşirik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selda Ateş Beşirik, PhD.

Role: PRINCIPAL_INVESTIGATOR

Burdur Mehmet Akif Ersoy University

Emine Geçkil, Professor

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

Burdur Bucak State Hospital

Burdur, Bucak, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/435

Identifier Type: -

Identifier Source: org_study_id