The Effect of Thermal Heat Application on Colic in Infants

Istanbul University - Cerrahpasa

Status: Completed

Conditions: Infantile Colics

Treatments: Other: Warm Towel Application; Other: Cherry Pit Pillow Application

Study type: Interventional

Funder types: Other

Identifiers

NCT07435948

Ü.Ü. EBE ŞEYMA ŞANLI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: Under 12 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Cherry Pit Pillow Group

Experimental group

Description:

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.

Treatment:

Other: Cherry Pit Pillow Application

Warm Towel Group

Experimental group

Description:

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.

Treatment:

Other: Warm Towel Application

Control Group

No Intervention group

Description:

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