The Effect of Thermal Heat Application on Colic in Infants

This study is a randomized controlled experimental trial designed to evaluate the effectiveness of thermal heat applications-specifically cherry pit pillows and warm towels-on reducing colic symptoms in infants aged 0-3 months. The study compares infants receiving these non-pharmacological thermal interventions with a control group receiving routine care, measuring outcomes such as colic severity, crying duration, feeding, and sleep patterns.

Study Overview

• Status: Completed
• Conditions: Infantile Colics
• Intervention / Treatment: Other: Cherry Pit Pillow Application; Other: Warm Towel Application

Detailed Description

Infantile colic is a common condition characterized by recurrent and prolonged crying episodes in healthy infants. Owing to the limited effectiveness of pharmacological treatments, there is a strong need for reliable non-pharmacological methods. This pre-test, post-test randomized controlled experimental study was conducted to investigate the effects of thermal heat application on colic in infants aged 0-3 months.

The sample consists of 75 infants diagnosed with colic, who were randomly assigned into three equal groups using block randomization: a cherry pit pillow application group (n=25), a warm towel application group (n=25), and a control group (n=25). For the intervention groups, the heated materials (cherry pit pillow or warm towel) were applied to the infant's abdominal area for 15 minutes per session, three days a week, over a two-week period. The control group received routine care without any specific thermal intervention.

Data to evaluate the effectiveness of the applications were systematically collected using the Family Introduction Form, the Infantile Colic Scale (ICS), and the 24-hour Colic Baby Diary.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Zeyti̇nburnu
    • Istanbul, Zeyti̇nburnu, Turkey (Türkiye), 34020
      • Suleymaniye Obstetrics and Gynaecology and Child Diseases Annex Building, Istanbul Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Infants diagnosed with infantile colic. Aged 0-12 weeks. Born at term (37-42 weeks gestational age). Birth weight between 2500-4500 grams.

Exclusion Criteria:

Premature birth (less than 37 weeks). Presence of any chronic disease or gastrointestinal anomaly. Lactose intolerance or cow's milk protein allergy. Infants who had taken medication in the previous 24 hours.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cherry Pit Pillow Group; Infants in this group received thermal application using a cherry pit pillow. The pillow was heated in a preheated 120-degree oven for 15 minutes and applied to the infant's abdominal area for 15 minutes, 3 days a week for 2 weeks.	Other: Cherry Pit Pillow Application; Application of a heated cherry pit pillow to the infant's abdominal area to reduce colic symptoms.
Experimental: Warm Towel Group; Infants in this group received thermal application using a warm towel. A towel was preheated in a 120-degree oven for 15 minutes and wrapped around the abdominal area for 15 minutes, 3 days a week for 2 weeks.	Other: Warm Towel Application; Application of a heated warm towel to the infant's abdominal area to reduce colic symptoms.
No Intervention: Control Group; Infants in this group received only routine care without any specific thermal intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Daily Crying and Sleep Durations	The daily durations of the infants' crying, sleeping, feeding, and normal behaviors were recorded using the 24-hour Colic Baby Diary (Barr Diary). This allows for objective analysis of the effectiveness of the thermal methods on crying frequency and sleep regularity.	Daily for 2 weeks
Change in Infant Colic Scale (ICS) Scores	The scale assesses the severity of colic. It consists of 19 items and five sub-dimensions: cow's milk/soy protein allergy/intolerance, immature digestive system, immature central nervous system, difficult baby, and problematic parent-baby interaction. Items are rated on a Likert scale ranging from 1 to 6. A lower total score indicates a decrease in colic severity.	From baseline (pre-test) to 2 weeks (post-test)

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Collaborators: Istanbul Training and Research Hospital; Uskudar University
• Investigators: Principal Investigator: ŞEYMA ŞANLI, Üsküdar UniversityÜsküdar University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: February 21, 2026
• First Submitted That Met QC Criteria: February 21, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Non-pharmacological treatment; Infantile colic; Cherry pit pillow; Warm towel
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Colic
• Other Study ID Numbers: Ü.Ü. EBE ŞEYMA ŞANLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect the privacy of the infants and their families, as per the ethical approval constraints of Uskudar University (Decision No: 2024-76)

Drug and device information, study documents

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