Infantile ColicNCT06743971
0-3 Months Infantile Colic The Effect of Ocean Sound on Babies
A study testing ocean sound concert in people with Infantile Colic, run by Zonguldak Bulent Ecevit University.
Trial summary
Infant colic is one of the most common health problems in newborns and infants. It is a syndrome of unknown cause, occurring in attacks, weakened by clenched fists, hardening of the abdomen, flatulence, pulling the legs to the abdomen, very difficult to stop and excessive crying. Read more about this study
- Who is it for?
- Ages 0 days to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Infantile Colic
- What is being tested?
- ocean sound concert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 days to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Volunteering to participate in the study
- Diagnosis of infantile colic according to Wessel criteria
- The baby is born prematurely/maturely
- The baby is between 0-3 months
- Babies must have passed the newborn hearing screening test (the sound level used during the test is set at 30 decibels)
- Otoscopic examinations of babies should be performed by a specialist physician
Show all 10Show fewer
- The baby has no diagnosis other than infantile colic on examination
- The baby does not have any chronic disease
- Mothers know how to read, write and speak Turkish
- No alternative application (massage, oil, herbal teas, etc.) should be used before the application
Who cannot join
- The baby has any acute and chronic disease
- The baby has a congenital anomaly
- The mother has diagnosed mental and psychological problems
- Diagnosis of lactose intolerance in infants by a physician
- Previously diagnosed with Infantile Colic and continuing medical treatment
- Babies have not passed the newborn hearing screening test
- Otoscopic examinations of infants not performed by a specialist physician
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Infant colic is one of the most common health problems in newborns and infants. It is a syndrome of unknown cause, occurring in attacks, weakened by clenched fists, hardening of the abdomen, flatulence, pulling the legs to the abdomen, very difficult to stop and excessive crying. Various studies have been conducted on this subject and the incidence rates in healthy babies vary between 10-40%. Significant behavioral problems may arise in sleep, rest and feeding due to frequent and prolonged periods of arrest, which are considered to be the upper point of normal crying. In these mothers, symptoms such as helplessness, fatigue, insomnia, exhaustion, loss of life, feelings of inadequacy, anxiety and crying problems may occur. In these mothers, variability is also extended. While in the womb, the fetus is attuned to the sound of the blood in the mother's arteries and the rocking motion of her abdomen. During infancy, the uterus is constantly hearing sounds at a higher frequency than a vacuum cleaner and these sounds stimulate a calming reflex in the baby. Our aim in this study was to investigate the sound of the ocean in infants with infantile colic aged 0-3 months.
Read the detailed description
Infantile colic is one of the most common health problems in the neonatal and infancy periods. It is a syndrome of unknown cause, occurring in attacks, characterized by clenched fists, abdominal hardening, flatulence, pulling the legs to the abdomen, and excessive crying that is very difficult to stop.
Although there are different definitions of colic, according to Wessel's rule of thirds definition, which is the most widely accepted and accepted as a diagnostic criterion in most studies, unexplained and uncontrollable crying spells with onset in the first weeks, usually in the first 3 months, lasting more than 3 hours a day, more than 3 days a week and at least 3 weeks, usually occurring in the afternoon and evening hours are accepted as gas pains .
Various studies have been conducted on this subject and the incidence in healthy infants has been found to be between 10-40%.
Studies have reported that colic symptoms disappeared at the end of the 4th month in 90% of cases. Important behavioral problems may arise in the baby's sleep, rest and feeding due to frequent and prolonged crying bouts of the baby, which are considered the upper point of normal crying.
This may lead to symptoms such as helplessness, fatigue, insomnia, exhaustion, loss of self-confidence, feelings of inadequacy, anxiety and breastfeeding problems. Studies have shown that the frequency of depression also increases in these mothers.
The frequency of colic does not show any difference between boys and girls, breastfed or formula-fed infants, term and preterm infants. It has been reported that colic is associated with marital problems, parental stress perception, lack of parental self-confidence during pregnancy, dissatisfaction with childbirth and family stress levels. Colic is a condition that needs to be managed well because it causes stress in the mother and physician as well as the baby, causes anxiety and depression in the mother, causes breastfeeding to be interrupted and formula to be given instead of breast milk, and increased risk of battering.
Although the causes of colic cannot be fully explained, factors such as food allergy or lactose intolerance, hypersensitivity, abnormal peristalsis or excessive gas, tension and stress in the family, bottle feeding or swallowing air during excessive crying, gastro-esophageal reflux, low birth weight, psychosocial problems in the mother are thought to cause colic. Since the cause is not known exactly, there is no definitive treatment. Some treatment methods are recommended to relieve symptoms. These symptomatic treatment methods include medication, diet and behavioral approaches.
Transition from the womb to the outside world is a very challenging situation for the child. Leaving the mother's womb, where all needs are met, and coming into the world, needing someone else to survive, can be a complete shock for the baby. While some babies adapt easily, others cannot.
Hearing is the baby's ability to distinguish sounds of different frequency, intensity and duration. It is an important sensory experience that begins in the intrauterine period and can lead to physiological and behavioral consequences throughout life.
This may lead to symptoms such as helplessness, fatigue, insomnia, exhaustion, loss of self-confidence, feelings of inadequacy, anxiety and breastfeeding problems. Studies have also shown that the frequency of depression increases in these mothers. One of these scientists, Dr. Harvey Karp, is the scientist who says that there are some things that can be done to make the baby feel as if he/she is in the womb after coming home.
While in the womb, the fetus is habituated to the sound of blood in the mother's arteries and the rocking motion of the abdomen. While in the uterus, the fetus constantly hears sounds with a frequency higher than that of a vacuum cleaner, which stimulate a calming reflex in the fetus.
Music is a natural method used in pain management because of its ease of use. The mechanism by which music therapy relieves pain is not known exactly. It is thought to have a relaxation or distraction effect. Many babies can be calmed by the sound of a fan or vacuum cleaner, tape recordings of the rumblings heard in the womb, sounds in nature or their fathers' voices.
In experiments, it was observed that newborn babies lying in a room where the sound of the uterus was played on a tape recorder fell asleep earlier than babies lying in a room where no sound was played. This is considered to be an indication that newborns begin to gain a certain sensitivity to music before they are born.
The aim of this study was to investigate the effect of ocean sound on symptoms in infants with infantile colic aged 0-3 months.
- Conditions
- Infantile Colic
- Being tested
- ocean sound concert
- Keywords
- pediatric nurse, infantil colic, cry, sleep
- Medical subject headings
- Colic, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocean sound concertBehavioural
intervention group listened to the ocean sound, the control group continued their daily care routines
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Parents will let their babies listen to ocean sounds during colic cries for 1 week. Receives: Behavioral: ocean sound concert |
| control | No intervention | Parents will continue with routine care practices during the baby's colicky cries |
What is being measured
The primary outcome is the main question the study is designed to answer.
listening to ocean sounds reduces colic symptoms
the sound of the ocean will be played to babies as an intervention. The effect of ocean sound on the infant's crying and sleep duration and infantile colic scale score will be monitored.
Measured: babies in the intervention group will be played the sound of the ocean when crying for a week after the first encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÖZLEM YÜKSEL ALTUNTAŞ, Zonguldak Bulent Ecevit University
- Investigators
- TÜLAY KUZLU AYYILDIZ, Study director, ZONGULDAK BÜLENT ECEVİT ÜNİVERSİTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743971
- Sponsor's protocol ID
- OALTUNTAS
- Status last verified
- Dec 2024
- First submitted
- 10 Jun 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 0-3 Months Infantile Colic The Effect of Ocean Sound on Babies
- ClinicalTrials.gov ID
- NCT06743971
- Acronym / sponsor ID
- OALTUNTAS
- Conditions
- Infantile Colic
- Keywords
- pediatric nurse, infantil colic, cry, sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 20 Dec 2024 (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.
Infant colic is one of the most common health problems in newborns and infants. It is a syndrome of unknown cause, occurring in attacks, weakened by clenched fists, hardening of the abdomen, flatulence, pulling the legs to the abdomen, very difficult to stop and excessive crying. Various studies have been conducted on this subject and the incidence rates in healthy babies vary between 10-40%. Significant behavioral problems may arise in sleep, rest and feeding due to frequent and prolonged periods of arrest, which are considered to be the upper point of normal crying. In these mothers, symptoms such as helplessness, fatigue, insomnia, exhaustion, loss of life, feelings of inadequacy, anxiety and crying problems may occur. In these mothers, variability is also extended. While in the womb, the fetus is attuned to the sound of the blood in the mother's arteries and the rocking motion of her abdomen. During infancy, the uterus is constantly hearing sounds at a higher frequency than a vacuum cleaner and these sounds stimulate a calming reflex in the baby. Our aim in this study was to investigate the sound of the ocean in infants with infantile colic aged 0-3 months.
Detailed description
Infantile colic is one of the most common health problems in the neonatal and infancy periods. It is a syndrome of unknown cause, occurring in attacks, characterized by clenched fists, abdominal hardening, flatulence, pulling the legs to the abdomen, and excessive crying that is very difficult to stop.
Although there are different definitions of colic, according to Wessel's rule of thirds definition, which is the most widely accepted and accepted as a diagnostic criterion in most studies, unexplained and uncontrollable crying spells with onset in the first weeks, usually in the first 3 months, lasting more than 3 hours a day, more than 3 days a week and at least 3 weeks, usually occurring in the afternoon and evening hours are accepted as gas pains .
Various studies have been conducted on this subject and the incidence in healthy infants has been found to be between 10-40%.
Studies have reported that colic symptoms disappeared at the end of the 4th month in 90% of cases. Important behavioral problems may arise in the baby's sleep, rest and feeding due to frequent and prolonged crying bouts of the baby, which are considered the upper point of normal crying.
This may lead to symptoms such as helplessness, fatigue, insomnia, exhaustion, loss of self-confidence, feelings of inadequacy, anxiety and breastfeeding problems. Studies have shown that the frequency of depression also increases in these mothers.
The frequency of colic does not show any difference between boys and girls, breastfed or formula-fed infants, term and preterm infants. It has been reported that colic is associated with marital problems, parental stress perception, lack of parental self-confidence during pregnancy, dissatisfaction with childbirth and family stress levels. Colic is a condition that needs to be managed well because it causes stress in the mother and physician as well as the baby, causes anxiety and depression in the mother, causes breastfeeding to be interrupted and formula to be given instead of breast milk, and increased risk of battering.
Although the causes of colic cannot be fully explained, factors such as food allergy or lactose intolerance, hypersensitivity, abnormal peristalsis or excessive gas, tension and stress in the family, bottle feeding or swallowing air during excessive crying, gastro-esophageal reflux, low birth weight, psychosocial problems in the mother are thought to cause colic. Since the cause is not known exactly, there is no definitive treatment. Some treatment methods are recommended to relieve symptoms. These symptomatic treatment methods include medication, diet and behavioral approaches.
Transition from the womb to the outside world is a very challenging situation for the child. Leaving the mother's womb, where all needs are met, and coming into the world, needing someone else to survive, can be a complete shock for the baby. While some babies adapt easily, others cannot.
Hearing is the baby's ability to distinguish sounds of different frequency, intensity and duration. It is an important sensory experience that begins in the intrauterine period and can lead to physiological and behavioral consequences throughout life.
This may lead to symptoms such as helplessness, fatigue, insomnia, exhaustion, loss of self-confidence, feelings of inadequacy, anxiety and breastfeeding problems. Studies have also shown that the frequency of depression increases in these mothers. One of these scientists, Dr. Harvey Karp, is the scientist who says that there are some things that can be done to make the baby feel as if he/she is in the womb after coming home.
While in the womb, the fetus is habituated to the sound of blood in the mother's arteries and the rocking motion of the abdomen. While in the uterus, the fetus constantly hears sounds with a frequency higher than that of a vacuum cleaner, which stimulate a calming reflex in the fetus.
Music is a natural method used in pain management because of its ease of use. The mechanism by which music therapy relieves pain is not known exactly. It is thought to have a relaxation or distraction effect. Many babies can be calmed by the sound of a fan or vacuum cleaner, tape recordings of the rumblings heard in the womb, sounds in nature or their fathers' voices.
In experiments, it was observed that newborn babies lying in a room where the sound of the uterus was played on a tape recorder fell asleep earlier than babies lying in a room where no sound was played. This is considered to be an indication that newborns begin to gain a certain sensitivity to music before they are born.
The aim of this study was to investigate the effect of ocean sound on symptoms in infants with infantile colic aged 0-3 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: ocean sound concertParents will let their babies listen to ocean sounds during colic cries for 1 week. |
| control | No intervention | –Parents will continue with routine care practices during the baby's colicky cries |
Who may qualify
- Ages
- 0 days to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Volunteering to participate in the study
- Diagnosis of infantile colic according to Wessel criteria
- The baby is born prematurely/maturely
- The baby is between 0-3 months
- Babies must have passed the newborn hearing screening test (the sound level used during the test is set at 30 decibels)
Key exclusion criteria (7 listed)
- The baby has any acute and chronic disease
- The baby has a congenital anomaly
- The mother has diagnosed mental and psychological problems
- Diagnosis of lactose intolerance in infants by a physician
- Previously diagnosed with Infantile Colic and continuing medical treatment
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 |
|---|---|---|
| ocean sound concertintervention group listened to the ocean sound, the control group continued their daily care routines | Behavioural | experimental |
Primary outcome
listening to ocean sounds reduces colic symptoms
Time frame: babies in the intervention group will be played the sound of the ocean when crying for a week after the first encounter
the sound of the ocean will be played to babies as an intervention. The effect of ocean sound on the infant's crying and sleep duration and infantile colic scale score will be monitored.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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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.
TÜLAY KUZLU AYYILDIZ study director
ZONGULDAK BÜLENT ECEVİT ÜNİVERSİTESİ
Questions about this trial
What is this clinical trial studying?
A study testing ocean sound concert in people with Infantile Colic, run by Zonguldak Bulent Ecevit University.
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 10 inclusion and 7 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: opening soon, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özlem YÜKSEL ALTUNTAŞ (05444295701, ozlemyuksel_41@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
listening to ocean sounds reduces colic symptoms (time frame: babies in the intervention group will be played the sound of the ocean when crying for a week after the first encounter). 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 20 Dec 2024.