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NCT Number: NCT07435948

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.

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Key information

Conditions

Infantile Colics Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

0 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suleymaniye Obstetrics and Gynaecology and Child Diseases Annex Building, Istanbul Training and Research Hospital

Istanbul, Zeyti̇nburnu, 34020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cherry Pit Pillow Application

Other

Application of a heated cherry pit pillow to the infant's abdominal area to reduce colic symptoms.

Warm Towel Application

Other

Application of a heated warm towel to the infant's abdominal area to reduce colic symptoms.

Primary outcomes

  1. Change in Daily Crying and Sleep Durations

    Time frame: Daily for 2 weeks

    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.

  2. Change in Infant Colic Scale (ICS) Scores

    Time frame: From baseline (pre-test) to 2 weeks (post-test)

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Istanbul Training and Research Hospital
  • Uskudar University

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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