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临床试验/NCT05489861
NCT05489861Unknown不适用

The Effect of Affirmation and Massage on Babies on Sleep Quality and Maternal-Paternal Attachment: Randomized Controlled Experimental Study

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Examining the infant's sleep quality of infant massage and affirmation

研究概览

简要总结

The research was designed as a randomized controlled trial model to examine the effects of affirmation and infant massage taught to the parents of 0-6 month-old infants registered in a Family Health Center and a Private Medical Center in Istanbul, on the sleep quality of their infants and mother-father-infant attachment. The research will be carried out between August and October 2022 by including the parents of the babies in the scope of the study. The Mother-Father and Infant Information Form and the Extended Infant Short Sleep Questionnaire, the Maternal Attachment Scale, and the Father-Infant Attachment Scale will be used to collect the data.

详细描述

This study was designed as a randomized controlled experimental study with the aim of examining the effect of affirmation and massage applied by mothers and fathers to their infants on their infants' sleep quality and maternal-paternal attachment. Infants aged 0-6 months will be included in the study. In the study, 15 babies (d=0.80, G=0.80, p=0.05) will be randomly selected for each group, Experimental Group 1: The Group To which the Mother Applies Affirmation and Massage (A), Experimental Group 2: The Group To which the Father Applies Affirmation and Massage (B) and Control Group (C) will be determined as three groups. Some criteria will be considered in infants selected and not selected into groups.

Experimental Group 1: Mothers in Group (A) Affirmation and Massage, Experimental Group 2: Fathers in Group (B) Affirmation and Massage, 3 days a week for 15 minutes, will be taught to apply affirmation and massage. Affirmation and massage applications will be shown once in the practice hall of the center as an example for the mother and father to be applied to their baby. Afterwards, affirmation and massage applications will be applied by the mother and father at the baby's home. After 5 weeks, the experimental and control groups will be invited to the center and the results will be compared by measuring with the data collection tools again.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Healthy infants
  • Non-pregnant mothers
  • Mothers and fathers who agree to participate in the study
  • Who do not have communication problems
  • Who does not have a chronic and mental disease

排除标准

  • Babies with any disease
  • Diagnosed with sleep a disorder

结局指标

主要结局

Examining the infant's sleep quality of infant massage and affirmation

时间窗: 5. week

The extended Infant Short Sleep Questionnaire will be used. At the beginning and end of the research. It will apply to both mothers and fathers. This scale does not have a score. The questionnaire has 13 items based on parents' reports of the baby's sleep patterns.

Effect on maternal attachment

时间窗: 5. weeks

The Maternal Attachment Inventory will be used. At the beginning and end of the research. Cronbach's alpha values are 0.77 in the first month and 0.82 in the 4th month for mothers. It will only apply to mothers. It is a 26-item scale. this scale's high point is 104 and the low point is 98. A high score on the scale indicates high maternal attachment

Effect on paternal attachment

时间窗: 5. weeks

The paternal-infant attachment scale will be used. At the beginning and end of the research. It will only apply to fathers. It is a 19-item scale. this scale's high point is 90 and the low point is 18. Each item of the scale is scored between one and five points. Higher scores indicate higher attachment.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nilay Şener Özovalı

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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