The Effect of Thermal Heat Application on Colic in Infants

NCT07435948 | Completed

• 1 other identifier: Ü.Ü. EBE ŞEYMA ŞANLI
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infantile Colics

Keywords

Infantile colic; Cherry pit pillow; Warm towel; Non-pharmacological treatment

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

Cherry Pit Pillow Group

EXPERIMENTAL

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

Warm Towel Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Cherry Pit Pillow Application OTHER

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

Cherry Pit Pillow Group

Warm Towel Application OTHER

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

Warm Towel Group

Eligibility Criteria

• Age: 0 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Uskudar University: collaborator
• Istanbul Training and Research Hospital: collaborator

Study Sites (1)

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

Istanbul, Zeyti̇nburnu, 34020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• ŞEYMA ŞANLI

  Üsküdar UniversityÜsküdar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: April 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)