Infantile ColicsNCT07435948
The Effect of Thermal Heat Application on Colic in Infants
A study testing Cherry Pit Pillow Application and Warm Towel Application in people with Infantile Colics, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 12 weeks
- Conditions the study is for
- Infantile Colics
- What is being tested?
- Cherry Pit Pillow Application and Warm Towel Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants diagnosed with infantile colic. Aged 0-12 weeks. Born at term (37-42 weeks gestational age). Birth weight between 2500-4500 grams.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleymaniye Obstetrics and Gynaecology and Child Diseases Annex Building, Istanbul Training and Research Hospital
Istanbul, Zeyti̇nburnu, 34020
About this study
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.
- Conditions
- Infantile Colics
- Being tested
- Cherry Pit Pillow Application, Warm Towel Application
- Keywords
- Infantile colic, Cherry pit pillow, Warm towel, Non-pharmacological treatment
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cherry Pit Pillow ApplicationOther
Application of a heated cherry pit pillow to the infant's abdominal area to reduce colic symptoms.
Warm Towel ApplicationOther
Application of a heated warm towel to the infant's abdominal area to reduce colic symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Warm Towel Application |
| Control Group | No intervention | Infants in this group received only routine care without any specific thermal intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline (pre-test) to 2 weeks (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Apr 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University, Istanbul Training and Research Hospital
- Responsible party
- Principal investigator, Ayça Demir Yıldırım, PhD, Istanbul University - Cerrahpasa
- Investigators
- ŞEYMA ŞANLI, Principal investigator, Üsküdar UniversityÜsküdar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435948
- Sponsor's protocol ID
- Ü.Ü. EBE ŞEYMA ŞANLI
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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)
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thermal Heat Application on Colic in Infants
- ClinicalTrials.gov ID
- NCT07435948
- Acronym / sponsor ID
- Ü.Ü. EBE ŞEYMA ŞANLI
- Conditions
- Infantile Colics
- Keywords
- Infantile colic, Cherry pit pillow, Warm towel, Non-pharmacological treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Uskudar University, Istanbul Training and Research Hospital
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cherry Pit Pillow Group | Experimental | Other: Cherry Pit Pillow ApplicationInfants 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. |
| Warm Towel Group | Experimental | Other: Warm Towel ApplicationInfants 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. |
| Control Group | No intervention | –Infants in this group received only routine care without any specific thermal intervention. |
Who may qualify
- Ages
- 0 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants diagnosed with infantile colic. Aged 0-12 weeks. Born at term (37-42 weeks gestational age). Birth weight between 2500-4500 grams.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cherry Pit Pillow ApplicationApplication of a heated cherry pit pillow to the infant's abdominal area to reduce colic symptoms. | Other | Cherry Pit Pillow Group |
| Warm Towel ApplicationApplication of a heated warm towel to the infant's abdominal area to reduce colic symptoms. | Other | Warm Towel Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ŞEYMA ŞANLI principal investigator
Üsküdar UniversityÜsküdar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cherry Pit Pillow Application and Warm Towel Application in people with Infantile Colics, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daily Crying and Sleep Durations (time frame: Daily for 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.