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

NCT06353841 | Completed

• 1 other identifier: 2023/435
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Constipation; Therapeutic Touch; Infants; Children; Constipation

Keywords

Therapeutic Touch; Functional Constipation; Infants; Children

Outcome Measures

Primary Outcomes (5)

• Primary Results Follow-up Form

  Weekly Bowel sounds (movements) (min)

  In four weeks

• Primary Results Follow-up Form

  Number of stools

  In four weeks

• Primary Results Follow-up Form

  Stool density

  In four weeks

• Primary Results Follow-up Form

  Weight (g)

  In four weeks

• Primary Results Follow-up Form

  Abdominal circumference (cm)

  In four weeks

Secondary Outcomes (2)

• Bristol Stool Scale

  In four weeks

• Constipation discomfort

  In four weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Therapeutic Touch 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.

Intervention Group

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Bucak State Hospital

Burdur, Bucak, 15030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Selda Ateş Beşirik, PhD.

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

• Emine Geçkil, Professor

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data analyst will be blinded to the procedure and results of randomization, group allocation, and intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 9, 2024
• Study Start: May 3, 2023
• Primary Completion: December 26, 2024
• Study Completion: December 31, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

TU (1)