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临床试验/NCT05525624
NCT05525624已完成不适用

Evaluation of the Effectiveness of Transition Model-Based Discharge Training in Parents of Preterm Infants:Double Blinded A Randomized Controlled Study

Suleyman Demirel University4 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2021年1月5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
200
试验地点
4
主要终点
Effect of TRAMPRE

研究概览

简要总结

Infant and Child Monitoring Protocol prepared by the General Directorate of Mother and Child Health and Family Planning of the Ministry of Health regarding the monitoring of postpartum processes in our country. However, there is no separate recommendation for home follow-up and care of mothers and babies who gave birth preterm. In addition, there are deficiencies in the effective conduct of home visits specified in these guides. In addition to the parents' lack of knowledge about the long-term follow-up and care of these babies, the coordination between primary and secondary health care providers and senior health care providers is not at the desired level. In addition to all these, services such as training and consultancy cannot be carried out due to disruptions in many polyclinic services due to the COVID-19 pandemic worldwide. For this reason, there is a need to develop programs for home care and follow-up of preterm infants, who are a sensitive population, in terms of both reducing the patient density in hospitals and reducing the hospital return rates of preterm infants. In this context, the aim of our research is; The aim of this study is to evaluate the effectiveness of discharge training based on the Transition Model in parents with preterm infants.H1: In the group in which the interventions based on the Transition Model are applied, the information needs of the parents will be met more compared to the control group. H1: Parent-infant role development will be higher in the group in which interventions based on the Transition Model are applied. H1: The level of coping with stress will be better in the group in which interventions based on the Transition Model are applied. H1: The level of grief will be lower in the group in which interventions based on the Transition Model are applied. H1: The level of postpartum depression will be lower in the group in which interventions based on the Transition Model are applied. H1: Babies in the group in which interventions based on the Transition Model are applied will have fewer hospital admissions, except for the planned outpatient visit

详细描述

Intervention Group: The intervention protocol of the research will be based on the Transition Model. Discharge training will be applied to the participants in line with the "Preterm Baby Care Guide" at the discharge stage. Weekly telephone follow-up will be carried out for 12 weeks after discharge. Applications to be made to the initiative group are given below. Phone Follow-up/Interview: During the first 12 weeks following the discharge of the preterm baby, parents will be interviewed by phone at least once a week. During the interview, issues concerning the baby's health status (baby bed, physical conditions of the house, newborn jaundice, nutrition, etc.) will be included in the scope of the interview and suggestions will be made for the baby's growth and development in healthy conditions (safe sleep, clothing selection, etc.). Interviews will be held in line with the "Baby Care Skill Form" and each interview will be recorded in the form. The duration and number of interviews will be determined according to the needs of the parent. In addition, in this process, information such as which health institution application has been made, the degree of the institution applied (primary / secondary / tertiary health institution) will be recorded. Control Group: Participants in this group will be included in the routine neonatal clinic discharge training of the hospital where the research was conducted and no intervention will be applied. The Parents and Preterm Baby General Information Form will be applied to the parents who agreed to participate in the study at the first interview, and when the data collection process of the research is completed, these parents will be contacted by phone and the Transition Scale and Edinburgh Postnatal Depression Scale will be applied. As in the intervention group, information such as the status of application to the health institution, the reason for the application and the degree of the institution applied to (primary / secondary / tertiary health institution) will be recorded in this group. Statistical Package of Social Science (SPSS 23) package program will be used in the evaluation of the data obtained from the research. For the intervention and control groups, the Cronbach Alpha coefficient, scale score average and minimum-maximum values will be calculated for the pre-test and post-test. In order to compare the pre-test and post-test data of the intervention and control groups, the t-test for the difference of the mean of the two peer groups (t-test of two paired groups), the Wilcoxon Signed Ranks Test, and the Wilcoxon Signed Ranks Test, and the Mann Whitney-U Test for the data without normal distribution will be performed.

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 (Investigator, Outcomes Assessor)

盲法说明

The research will be conducted in a double-blind design and the data of the research will be collected by the clinical nurse. Parents participating in the research will not know that they are in the intervention or control group. Telephone support during the research process will be provided by an independent interviewer.

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • For mothers;
  • Having given birth between 340/7-366/7 weeks
  • Absence of a chronic disease that may affect physical and mental care
  • Residing within the provincial borders of Antalya
  • For babies;
  • No congenital anomalies
  • Postpartum neonatal asphyxia, respiratory distress syndrome, intraventricular hemorrhage and necrotizing enterocolitis etc. no problem
  • Postpartum Apgar score >7 Babies discharged after being followed up in
  • The neonatal clinic will be included in the study

排除标准

  • For mothers;
  • *Having a physical or mental chronic illness that may affect the baby's care process
  • For babies;
  • Neonatal asphyxia, respiratory distress syndrome, intraventricular hemorrhage and necrotizing enterocolitis etc. receiving ventilator support after delivery.
  • Babies with a problem will not be included in the study.

结局指标

主要结局

Effect of TRAMPRE

时间窗: Change from baseline effect of TRAMPRE at 3 months

TRAMPRE will be applied to the participants in line with the "Preterm Baby Care Guide" at the discharge stage. Weekly telephone follow-up will be carried out for 12 weeks after discharge. Applications to be made to the initiative group are given below. Phone Follow-up/Interview: During the first 12 weeks following the discharge of the preterm baby, parents will be interviewed by phone at least once a week.

次要结局

  • Frequency of readmission(Change from baseline Frequency of readmission at 3 months)
  • Level of postpartum depression(Change from baseline level of postpartum depression at 3 months)

研究者

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

Serife Tutar

Dr.Şerife Tutar

Suleyman Demirel University

研究点 (4)

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