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临床试验/NCT06197100
NCT06197100尚未招募不适用

Effectiveness of Supportive Care Training Given to Mothers of Babies With Infant Colic: Randomized Controlled Study

Kirsehir Ahi Evran Universitesi2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1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
试验地点
2
主要终点
Breastfeeding Self-efficacy

研究概览

简要总结

Infantile Colic is a non-pathological condition that causes babies to cry excessively throughout their first few months of life. It has a prevalence of 15-30% and is defined by excessive sobbing for at least 3 hours per day, 3 days per week for around 3 weeks.

Excessive sobbing, blushing, parachroma around the lips, bloating in the abdomen, drawing the legs into the abdomen, coldness at the ends, and fisting of the hands are all symptoms of infantile colic. Another significant clinical aspect of Infantile Colic is its protracted, difficult to soothe, and inexplicable nature. Infantile Colic is thought to have a cicadian pain cycle that begins in the evening.

Infantile Colic is a non-pathological condition that causes babies to cry excessively throughout their first few months of life. It has a prevalence of 15-30% and is defined by excessive sobbing for at least 3 hours per day, 3 days per week for around 3 weeks.

Excessive sobbing, blushing, parachroma around the lips, bloating in the abdomen, drawing the legs into the abdomen, coldness at the ends, and fisting of the hands are all symptoms of infantile colic. Another significant clinical aspect of Infantile Colic is its protracted, difficult to soothe, and inexplicable nature. Infantile Colic is thought to have a cicadian pain cycle that begins in the evening.

Anxiety and stress that arise during the postpartum period cause a variety of issues in both the mother and the baby, and have a negative impact on the mother-baby bond as well as the mother's care and parenting skills. Sleep deprivation, sleep disturbance, and exhaustion are said to be caused by the sensation of not being able to meet the child's demands. It has been found that as parental stress levels rise, the gut flora deteriorates, and increasing cortisol in breast milk increases the baby's crying attacks. Colic and excessive crying are also risk factors for unfavorable parent-infant interactions. Infantile Colic has been shown to have a negative impact on children's health in the short and long term for all of these reasons. As a result, healthcare experts must devise therapies to lessen the painful impact of Infantile Colic on babies and their families. As a result, the purpose of this study was to see how supportive care training for parents affected the colic levels of babies with Infantile Colic, as well as mothers' perceptions of nursing and parental self-efficacy.

详细描述

Research hypotheses; Supportive care training for mothers of babies with infantile colic H1: Has an effect on the average nursing self-efficacy scores of moms of newborns with infantile colic.

H2: It affects the parental self-efficacy score averages of moms of infantile colic kids, H3: It influences the colic scores of infantile colic babies.

MATERIALS AND METHODS Type of Research Research; It was planned as a pretest-posttest randomized controlled experimental study.

Purpose of the research Research; It was planned to determine the effect of the educational supportive care program for parents on the colic levels of babies with Infantile Colic, the parenting self-efficacy of mothers and the level of mother-infant attachment.

Place and Characteristics of the Research It will be held at the Pediatrics Polyclinic of Kırşehir Ahi Evran University Training and Research Hospital. There are 6 specialist physicians working in the pediatric outpatient clinic.

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)

入排标准

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

入选标准

  • Gestational week >37, birth weight >2500g,
  • No congenital anomalies related to the digestive system or nutrition,
  • Postnatal age of 1-3 months,
  • Not receiving colic treatment,
  • Diagnosed with Infantile colic by a pediatrician,
  • Babies who are exclusively breastfed,
  • Mothers of these babies who are over 18 years old, do not use sedative or antiepileptic drugs, can understand and communicate in Turkish, have no mental disabilities, and volunteer to participate in the study will be included in the research.

排除标准

  • Gestational week ≤ 37 and birth weight ≤ 2500g,
  • Those with metabolic disease and congenital anomalies of the digestive system,
  • treated for colic,
  • not breastfed,
  • Babies whose postnatal age is less than 1 month and more than 3 months

结局指标

主要结局

Breastfeeding Self-efficacy

时间窗: before intervention/15 days after the intervention

Breastfeeding Self-efficacy Scale: It is a scale consisting of 33 items developed by Dennis (1999). It consists of two sub-dimensions to determine mothers' breastfeeding skills, beliefs and behaviors regarding breastfeeding.

Infant Colic

时间窗: before intervention/15 days after the intervention

The Infant Colic Scale was developed in 2002 by Marsha L. Cirgin Ellet and her colleagues to assist healthcare professionals in diagnosing and evaluating colic. The scale consists of 5 sub-dimensions and 22 questions: Cow's milk/soy protein allergy/intolerance, immature digestive system, immature central nervous system, difficult baby, parent-infant interaction + problem baby.

Perceived Maternal Parenting Self-Efficacy

时间窗: before intervention/15 days after the intervention

Perceived Maternal Parenting Self-Efficacy Scale: It was created in 2007 by Barnes and Adamson-Macedo to assess the degree of self-efficacy among women who had babies early. The scale yields a minimum of 18 points and a maximum of 72 points. A rise in the score signifies an increase in the mother's degree of self-efficacy.

次要结局

未报告次要终点

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Tuba KOC

Child Health and Diseases Nursing Department President

Kirsehir Ahi Evran Universitesi

研究点 (2)

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