Not Yet RecruitingNot Applicable

0-3 Months Infantile Colic The Effect of Ocean Sound on Babies

60 participantsStarted 2024-12-15

Plain-language 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. 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.

Who can participate

Age range

0 Days – 3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

listening to ocean sounds reduces colic symptoms

Timeframe: babies in the intervention group will be played the sound of the ocean when crying for a week after the first encounter

Trial details

NCT IDNCT06743971

SponsorZonguldak Bulent Ecevit University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

Contact for this trial

Özlem YÜKSEL ALTUNTAŞ

05444295701 ozlemyuksel_41@hotmail.com

View on ClinicalTrials.gov More Infantile Colic trials