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临床试验/NCT05302700
NCT05302700已完成不适用

The Effectiveness of Early Parental Sensitivity Intervention on Attachment, Parenting Confidence and Parental Stress of Preterm Infant Mothers

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Maternal Confidence Questionnaire

研究概览

简要总结

In Taiwan, according to the birth notification statistics of the Ministry of Health and Welfare. 164,496 newborns were born in 2020, with preterm births accounting for about 11.58%.Most preterm infants need to be hospitalized for highly specialized care, resulting in the separation of preterm infants from their parents after birth, which may have a negative impact on the healthy attachment development between parents and preterm infants. Moreover, due to the vulnerability of preterm infants, parents often lack the confidence to take care of them.

详细描述

The study was a quantitative study of a randomized controlled trial, designed by experimental research method. Using GPower 3.1.2 to estimate the number of samples, and the statistical method chosen was Repeated measures ANOVA, the sample size was 80.

The subjects were divided into two groups, The control group received general routine nursing guidance, while the experimental group received general routine nursing guidance and early parental sensitivity intervention program. Using the NICU VR Tour and Premature Infant Behavioral Clues Teaching Materials as educational tools for early parental sensitivity intervention program. The outcome used the Maternal Attachment Inventory, Maternal Confidence Questionnaire and Parental Stressor Scale: Infant Hospitalization as evaluated tools.

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

年龄范围
20 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Preterm infants:
  • Preterm infants less than 37 weeks gestation and hospitalized in the NICU
  • The birth weight is classified as VLBW and LBW, and the birth weight is between 1,000-2,499gm
  • Preterm infant mothers:
  • Children have not been hospitalized in the NICU in the past
  • At least 20 years old
  • They can speak Chinese, Taiwanese fluently and need to be literate

排除标准

  • Preterm infants :
  • Combined congenital diseases and chromosomal abnormalities
  • Immediate surgery, first aid and unstable vital signs are necessary after birth
  • The birth weight is classified as ELBW, and the birth weight is less than 1,000gm
  • Preterm infant mothers:
  • Hospitalized in the intensive care unit

结局指标

主要结局

Maternal Confidence Questionnaire

时间窗: On the fifth to seventh day after birth of preterm infant.

Using the Maternal Confidence Questionnaire to measure parenting confidence.There are 14 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 14 to 70, with higher scores indicating better parenting confidence.

Maternal Attachment Inventory

时间窗: On the fifth to seventh day after birth of preterm infant.

Using the Maternal Attachment Inventory to measure mother-infant attachment.There are 22 items on the scale,each item was scored using a 4-point Likert scale.The total score ranges from 22 to 88, with higher scores indicating better attachment.

Parental Stressor Scale: Infant Hospitalization

时间窗: On the fifth to seventh day after birth of preterm infant.

Using the Parental Stressor Scale: Infant Hospitalization to measure parental stress.There are 21 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 21 to 105, with higher scores indicating greater stress.

次要结局

  • Maternal Attachment Inventory(The first month of birth of preterm infant.)
  • Maternal Confidence Questionnaire(The first month of birth of preterm infant.)
  • Parental Stressor Scale: Infant Hospitalization(The first month of birth of preterm infant.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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