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临床试验/NCT04741672
NCT04741672已完成不适用

Home Support for Mothers Whose Premature Infants Discharged From the Neonatal Intensive Care Unit: A Randomized Controlled Study

Akdeniz University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年2月22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
102
试验地点
1
主要终点
State Anxiety Inventory

研究概览

简要总结

Premature births are a challenging process for parents in many ways. Especially after the treatment and care in the hospital, they are concerned about whether they will be able to provide adequate care for their baby at home. The aim of this study is to examine the effect of the guide and telephone support given to mothers whose premature infants were discharged from the neonatal intensive care unit on the perceived maternal self-efficacy and state anxiety levels.

详细描述

The study was planned as a randomized controlled trial with a single blind, pretest-posttest design. This study will be conducted between February 2021 and March 2022 with premature infants mothers. The sample of the study will be mothers (n = 102) of premature infants discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit. 51 mothers participating in the study will be given a premature infant home care guide after the discharge routine procedures are completed. In addition, mothers will be given an appointment for a phone call a week later. No intervention will be applied to the other 51 mothers after their discharge routine. Data will be collected by Mother-Infant Descriptive Information Form, Perceived Maternity Self-Efficacy Scale (PMSES), State Anxiety Inventory (SAI). Data will be collected with forms and scales immediately after discharge (pre-test) and in the 4th week after discharge (post-test). Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University. It is predicted that the new information obtained from the research data will guide the education of premature infant mothers and new researches.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The control and intervention group will be formed by randomization. The intervention and control group will be defined as group 1 and group 2 for statistical analysis. Data analysis will be evaluated and reported by the statistician. Also the statistician will be blind.

入排标准

性别
Female
接受健康志愿者

入选标准

  • The infant was born prematurely (37 weeks of gestation + 6 days earlier),
  • Does not have advanced congenital anomalies in the baby,
  • Who will carry out the primary care of the infant at home,
  • Reading and writing,
  • Can speak and understand Turkish,
  • Mothers who agreed to participate in the study

排除标准

  • Incomplete filling of the forms
  • Mothers who previously had training in newborn care

结局指标

主要结局

State Anxiety Inventory

时间窗: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)

The scale was developed to measure what has been felt for the last 7 days. It is a Likert-type scale consisting of 20 items and graded between 1 and 4. The scores obtained from the scale range from 20 to 80.

Perceived Maternity Self-Efficacy Scale

时间窗: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)

The scale, valid and reliable in our country by Kadiroglu (2018), has 19 items and three sub-dimensions.A minimum of 19 and a maximum of 76 points can be obtained on the scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arzu Akcan

Assistant Professor

Akdeniz University

研究点 (1)

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