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CompletedNCT07435948Updated Feb 27, 2026

The Effect of Thermal Heat Application on Colic in Infants

An interventional study of Cherry Pit Pillow Application and Warm Towel Application in Infantile Colics, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to participants aged 0 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
0 Weeks to 12 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infantile Colics

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Keywords

  • Infantile colic
  • Cherry pit pillow
  • Warm towel
  • Non-pharmacological treatment
03

Who can participate

Ages eligible
0 Weeks to 12 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • 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

  • 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

  • No intervention
    Control Group

    Infants in this group received only routine care without any specific thermal intervention.

Interventions

  • OtherCherry Pit Pillow Application

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

  • OtherWarm Towel Application

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Daily for 2 weeks

  2. 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.

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

06

Study locations

1 site
  • Suleymaniye Obstetrics and Gynaecology and Child Diseases Annex Building, Istanbul Training and Research Hospital
    Istanbul, Zeyti̇nburnu 34020, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No — 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)

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07435948
Lead sponsor
Istanbul University - Cerrahpasa
Collaborators
Uskudar University, Istanbul Training and Research Hospital
Responsible party
Ayça Demir Yıldırım, PhD (Associate Professor, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Feb 27, 2026
Start date
Apr 15, 2025
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025
Last update
Feb 27, 2026

Study contacts

ŞEYMA ŞANLI
principal investigator · Üsküdar UniversityÜsküdar University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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