NCT07435948

The Effect of Thermal Heat Application on Colic in Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 0 Weeks – 12 Weeks
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Infantile Colics

Interventions

Type	Name	Description
OTHER	Cherry Pit Pillow Application	Application of a heated cherry pit pillow to the infant's abdominal area to reduce colic symptoms.
OTHER	Warm Towel Application	Application of a heated warm towel to the infant's abdominal area to reduce colic symptoms.

Timeline

• Start date: 2025-04-15
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Turkey (Türkiye)