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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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
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  • 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.

Özlem YÜKSEL ALTUNTAŞ contact

05444295701

ozlemyuksel_41@hotmail.com

Özlem YÜKSEL ALTUNTAŞ contact

05444295701

ozlemyuksel.41@gmail.com

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 groups in NCT06743971
Study groupRoleWhat they receive
experimentalExperimentalParents will let their babies listen to ocean sounds during colic cries for 1 week.
Receives: Behavioral: ocean sound concert
controlNo interventionParents 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.

  1. 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.

  1. First posted20 Dec 2024
  2. Study start15 Dec 2024 (estimated)
  3. Primary completion30 Jan 2025 (estimated)
  4. Study completion30 Jan 2025 (estimated)

Resources

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)
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

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.

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