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临床试验/NCT05521620
NCT05521620已完成不适用

What Effect Does a Father-friendly NICU Have on Children, Parents, and Staff?

Kolding Sygehus2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2011年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
2
主要终点
Nurses self-efficacy (Self-efficacy (SE))

研究概览

简要总结

An early parent-child relationship is important for a child's development, both intellectually and socially. The admission of premature or ill newborns to neonatal intensive care units (NICUs) may make the establishment of the parent-child relationship challenging due to parents' anxiety and despair.

Traditionally, most healthcare professionals have mainly focused on infants and mothers, even though fathers often feel stressed, powerless, and helpless, and find it difficult to establish a father-child relationship. The aim of this study is to investigate the effect of a father-friendly NICU on infants, parents and staff.

详细描述

An early parent-child relationship is important for a child's development, both intellectually and socially. The admission of premature or ill newborns to neonatal intensive care units (NICUs) may make the establishment of the parent-child relationship challenging due to parents' anxiety and despair.

Traditionally, most healthcare professionals have mainly focused on infants and mothers, even though fathers often feel stressed, powerless, and helpless, and find it difficult to establish a father-child relationship. The aim of this study is to investigate the effect of a father-friendly NICU on infants, parents and staff.

The study was conducted in 3 steps

  1. A baseline measurement
  2. Development and implementation of the intervention a father friendly NICU
  3. After measurement

Different questionnaires were used:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • fathers/mothers with infants admitted to the NICU were eligible
  • nurses who work in Danish NICUs

排除标准

  • fathers/mothers who did not understand verbal and written Danish
  • fathers/mothers of critically ill newborn infants
  • fathers of newborn infants whose mother was critically ill
  • fathers/mothers of newborn infants admitted to the NICU from home.
  • nurses without patient-contact, on maternity- or long-term sickness-leave

结局指标

主要结局

Nurses self-efficacy (Self-efficacy (SE))

时间窗: Before the start of the development of the intervention (August 2011) till 18 months after the implementation of the intervention (January 2015)

The primary outcome was the difference between the nurses' SE scores for father and mother questions in the intervention group in comparison with the control group The nurses were asked to evaluate own ability to guide and support the parents in different situations (Self-efficacy score). The SE score was rated on a scale ranging from 1, indicating "Not at all sure," to 10, indicating "Definitely sure".

Stress (The Parental Stressor Scale: Neonatal Intensive Care Unit)

时间窗: Measured on admission to the NICU (during the first 3 days of hospitalization), at the 14th day of hospitalization , and at the day of discharge from the NICU (up to 1/2 year)

The primary outcome was the difference in the overall stress score, determined using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) score in both the control and intervention groups. Fathers were asked to rate their stress related to particular situations on a 5-point Likert scale, ranging from 1 (not at all stressful) to 5 (extremely stressful). Fathers who had not experienced a particular situation on an item indicated this with a "not relevant" response. The maximal score was 5, a high score indicating a high level of paternal stress.

Parental Support (The Nurse Parent Support Tool)

时间窗: Measured on admission to the NICU (during the first 3 days of hospitalization), and at the day of discharge from the NICU (up to 1/2 year)

The primary outcome was the difference in fathers' perception of received staff support in the control group compared to the intervention group. The questionnaire included four dimensions of nurse support: 1) communication of information related to the infant's condition and care (nine items), 2) support mainly directed to enhance parental role (four items), 3) emotional support to help parents cope with their infant's sickness (three items), and 4) caregiving support concerning the quality of care provided to the infant (five items). For each item, the parents indicated the degree of support on a 5-point Likert scale ranging from 1 (never) to 5 (always) 19.

Self-efficacy follow-up

时间窗: After the implementation of the intervention (January 2015) to five years after (February 2021).

The primary outcome was the difference between the nurses' SE score on father and mother questions from after the implementation of the intervention to five years after. The nurses were asked to evaluate own ability to guide and support the parents in different situations (Self-efficacy score). The SE score was rated on a scale ranging from 1, indicating "Not at all sure," to 10, indicating "Definitely sure".

次要结局

未报告次要终点

研究者

发起方
Kolding Sygehus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Betty Nørgaard

Principal Investigator

Kolding Sygehus

研究点 (2)

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