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临床试验/NCT06299358
NCT06299358Unknown不适用

The Effect of Foot Massage and Maternal Heart Sound on Colic and Comfort Levels in Infants With Infantile Colic

Karamanoğlu Mehmetbey University2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2023年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Changes in comfort scale ratings as a result of maternal heart sound

研究概览

简要总结

Infantile colic is a developmental disorder that reduces comfort levels in infants with intense crying crises and has negative effects on the infant and family. The study is planned to measure the effect of the combination of maternal heart sound simulation, aromatic foot massage and maternal heart sound simulation and aromatic foot massage on the colic and comfort levels of infants with infantile colic. It is aimed to alleviate colic symptoms, increase comfort levels, regulate daily crying and sleep durations (increase in sleep durations, decrease in crying durations) and support the development of infants in this context by using maternal heart sound simulation, aromatic foot massage and their combined application.

详细描述

Infantile colic is a developmental disorder that occurs in the second week of extrauterine life, reaches its peak in the sixth week, continues up to four to six months, and negatively affects the infant and family in healthy infants who develop rapidly. Infantile colic is a very common disorder among functional gastrointestinal diseases. When the studies conducted to determine the prevalence of infantile colic are examined, it is seen that the prevalence varies according to the development level of the countries (prevalence increases as the development level decreases) and the average figures are %5-25.

Although there are many studies on infantile colic, there is no clear acceptance about its etiology. Regarding the etiology of infantile colic; it is mentioned that gastrointestinal, psychosocial and immature central nervous system causes may be triggering in the disease. In addition, low birth weight, lactose intolerance, food allergy (cow's milk), hypersensitivity, excessive gas, increased peristalsis, bottle feeding, swallowing excess air during crying, gastroesophageal reflux, perception of distension as pain due to immature intestinal structure, incompatibility in serotonin and melatonin circadian rhythm in the first three months, as well as factors such as family stress, anxiety and psychosocial problems in the mother may play a role in the disease.

In functional gastrointestinal disorders, the lack of a structural, anatomical or biochemical impairment that can provide an objective assessment of the disease makes the diagnostic process difficult. Considering the lack of verbal expression in infants, it is essential to use certain accepted criteria in the diagnostic process in order to make an objective diagnosis of the disease. Due to these requirements, the Wessel technique and Rome II-III-IV criteria were used in the diagnostic process of infantile colic, respectively, and the use of Wessel, Rome III-IV is still ongoing. The first description of infantile colic in infants was made by Wessel (1954). Wessel defined infantile colic as crying for more than three hours a day, for more than three days a week and for more than three weeks without any developmental or situational discomfort. The first use of a child-specific FGID diagnosis was in the Rome II criteria in 1999. The use of Rome II criteria did not meet the need due to lack of literature and evidence. Therefore, with the publication of Rome III criteria in 2006, the diagnostic process became more objective. With the studies conducted over the years, Rome III diagnostic criteria were revised in 2006 and Rome IV diagnostic criteria were started to be used in order to better understand the diseases and provide the best treatment.

Although there is no fixed treatment protocol in the treatment of infantile colic, pharmacological and non-pharmacological methods are used. Although pharmacological agents are occasionally used in treatment, dietary and behavioral treatment methods are mostly used in the treatment of the disease. Although pharmacologic treatment is occasionally used in infantile colic, studies do not support the use of any pharmacologic agent within the scope of evidence-based practice. In the pharmacologic treatment of infantile colic; Although drug groups such as anelgesics, antispasmolytics (especially simethicone, dicyclomine) and proton pump inhibitors are used, there is no evidence-based practice with usability because there is no specific treatment.

Since the foods consumed by the mother may affect the baby through milk, it is recommended to temporarily exclude foods such as citrus fruits, eggs, cola, cow's milk, chocolate, dried legumes, nuts and dairy products from the mother's diet. Herbal teas may improve the symptoms of infantile colic and may also provide sedation, but caution should be exercised because the level of evidence is not sufficient. The use of probiotics is another method that may alleviate colic symptoms because it improves the intestinal microbiota, and the use of hydrolyzed formulas with prebiotics is recommended in infants fed formula.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

In the study, interviews will be conducted at different times so that mothers or caregivers do not encounter mothers/caregivers in other groups. In this way, participant blinding will be ensured. Since the study will be conducted with newborns, no study will be conducted on other blinding techniques and biases. In order to prevent bias in the data evaluation process, each baby will be numbered by the researcher during the application and these numbers will be used by the statistical expert in statistical evaluations. The statistical expert will not learn the identity information of the participants and will only perform statistics according to the numbering.

入排标准

年龄范围
2 Weeks 至 16 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Babies crying more than three hours a day, three days a week, according to the Wessel technique,
  • Babies are between 2 and 16 weeks postpartum,
  • The baby does not have any other illness that may cause restlessness and crying,
  • The baby does not have a chronic disease,
  • Absence of any anomaly in the foot area that would prevent massage,
  • Babies have passed the hearing test,
  • Babies do not have a problem that prevents hearing,
  • Infants are not receiving pharmacologic treatment for infantile colic,
  • Infants are not receiving non-pharmacologic treatment for infantile colic,
  • Babies are not receiving any pharmacologic (analgesic/sedative) treatment that may affect pain and comfort.
  • Exclusion and

排除标准

  • Initiation of any pharmacologic treatment that may affect colic, comfort, sleep and crying times in infants included in the study,
  • Initiation of any non-pharmacologic treatment that may affect colic, comfort, sleep and crying times in infants included in the study,
  • Incomplete data.

研究组 & 干预措施

Foot massage group

Experimental

Foot massage will be performed by the researcher for 10 minutes on two consecutive days a week in the infants' own homes. In foot massage, euphlorage, petrisage and friction techniques will be used in the appropriate order.

Infants in the foot massage group will be visited five times in total, two times each in the first encounter, first and second weeks. Related forms (Infantile colic and newborn comfort behavior scale) will be filled out by the researcher three times in total, once for the first encounter and once for each week. A total of two forms related to crying and sleep, one for each week, will be completed by the mother at the end of the study. The maternal state-trait anxiety scale will be completed twice, at the first encounter and at the end of the intervention.

干预措施: Foot massage (Other)

Mother heart sound group

Experimental

For the group to listen to the mother's heart sounds, the heart sounds of the mothers of the babies will be recorded on an mp3 player in a quiet environment (in their own homes) with the help of hand-held doopes. The volume (65 decibels) and distance of the mp3 player will be determined by the researcher with the help of a decibel meter and the appropriate distance will be determined. The mother will play this sound to the infant for half an hour every day for two weeks, in coordination with the hours of the intervention in the other groups.

The infants in this group will be visited three times in total, once at the first encounter and once at the end of the first and second weekends, and the relevant forms (Infantile colic and newborn comfort behavior, state-trait anxiety scale) will be applied. Forms related to crying and sleep will be completed by the mother two times in total, one for each week.

干预措施: Mother heart sound (Other)

Foot massage and mother heart sound group (mixed group)

Experimental

For the group in which maternal heart sounds and foot massage will be applied, the heart sounds of the mothers of the babies will be recorded on an mp3 player in a quiet environment (in their own homes) with the help of hand-held doopes. The sound (65 decibels) and distance of the mp3 player will be determined by the researcher with the help of a decibel meter. The researcher will perform foot massage as in the massage group and the mother's heart sound will be played for a total of half an hour with the massage. The infants in this group will be visited five times in total, once in the first encounter and twice each in the first and second week, and the relevant forms (Infantile colic, neonatal comfort behavior scales will be applied 3 times for infants; state-trait anxiety scale will be applied twice for the mother, once at the beginning and twice at the end). A total of two forms related to crying and sleep will be completed by the mother, one for each week.

干预措施: Foot massage and maternal heart sound (Other)

结局指标

主要结局

Changes in comfort scale ratings as a result of maternal heart sound

时间窗: Two weeks

The comfort scale consists of 6 sub-dimensions.Each sub-dimension is evaluated between 1 and 5 points. Comfort is considered good if the total score is 15 or above, and inadequate if it is below.

Changes in colic scale assessments induced by foot massage

时间窗: Two weeks

The colic scale consists of 19 questions. The minimum score that can be obtained from the scale in total is 19 and the maximum score is 114. A score of 48 and above on the scale indicates the presence of colic.After 48 points, each point increase indicates an increase in the severity of colic

Changes in colic scale ratings induced by maternal heart sound

时间窗: Two weeks

The colic scale consists of 19 questions. The minimum score that can be obtained from the scale in total is 19 and the maximum score is 114. A score of 48 and above on the scale indicates the presence of colic.After 48 points, each point increase indicates an increase in the severity of colic

Changes in comfort scale assessments induced by foot massage

时间窗: Two weeks

The comfort scale consists of 6 sub-dimensions.Each sub-dimension is evaluated between 1 and 5 points. Comfort is considered good if the total score is 15 or above, and inadequate if it is below.

次要结局

未报告次要终点

研究者

发起方
Karamanoğlu Mehmetbey University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meltem Pepe

Lecturer

Karamanoğlu Mehmetbey University

研究点 (2)

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