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

NCT06743971 | Not Yet Recruiting

• 1 other identifier: OALTUNTAS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Infantile Colic

Keywords

pediatric nurse; infantil colic; cry; sleep

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

experimental

EXPERIMENTAL

Parents will let their babies listen to ocean sounds during colic cries for 1 week.

Behavioral: ocean sound concert

control

NO INTERVENTION

Parents will continue with routine care practices during the baby's colicky cries

Interventions

ocean sound concert BEHAVIORAL

intervention group listened to the ocean sound, the control group continued their daily care routines

experimental

Eligibility Criteria

• Age: 0 Days - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

MeSH Terms

Conditions

Colic; Crying

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nonverbal Communication; Communication; Behavior

Study Officials

• TÜLAY KUZLU AYYILDIZ

  ZONGULDAK BÜLENT ECEVİT ÜNİVERSİTESİ

  STUDY DIRECTOR

Central Study Contacts

Özlem YÜKSEL ALTUNTAŞ

CONTACT

05444295701; ozlemyuksel_41@hotmail.com

Özlem YÜKSEL ALTUNTAŞ

CONTACT

05444295701; ozlemyuksel.41@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: December 20, 2024
• Study Start: December 15, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12