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临床试验/NCT06743971
NCT06743971尚未招募不适用

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

Zonguldak Bulent Ecevit University0 个研究点目标入组 60 人开始时间: 2024年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
listening to ocean sounds reduces colic symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
0 Days 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

listening to ocean sounds reduces colic symptoms

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Zonguldak Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ÖZLEM YÜKSEL ALTUNTAŞ

Nurse

Zonguldak Bulent Ecevit University

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