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临床试验/NCT07534748
NCT07534748已完成不适用

Short Term Neonatal and Parents Outcomes in Low and High Risk Infants Undergoing Family Care Intervention

Inonu University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Parental Care Participation

研究概览

简要总结

This study aimed to evaluate the short-term neonatal and parental outcomes in low- and high-risk infants following a single-session family care education intervention. A total of 34 parent-infant dyads were included.

All parents received a structured, family care education during hospitalization. Parental depression, anxiety, care participation, and neonatal pain were assessed on the 10th day of hospitalization and at discharge.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Infants diagnosed as neurodevelopmentally at risk.
  • Infants born between 37 and 40 gestational weeks.
  • Infants with a birth weight below 2500 grams.
  • Infants who have been admitted to the neonatal intensive care unit for at least 10 days since birth.

排除标准

  • Infants whose families declined participation in the study.
  • Infants with congenital anomalies.

研究组 & 干预措施

Family Care Intervention

Other

干预措施: Family Care Intervention (Other)

结局指标

主要结局

Parental Care Participation

时间窗: 1 year

In this study, the "Care Participation Assessment Scale for Mothers with Infants Hospitalized in the Neonatal Intensive Care Unit" was used to evaluate the level of maternal participation in the care of their infants. The scale consists of 19 items assessing caregiving practices performed by mothers. Each item is scored dichotomously (Yes/No), with "Yes" scored as 1 and "No" as 0. The total score ranges from 0 to 19, with higher scores indicating greater participation in infant care.

Edinburgh Postnatal Depression Scale

时间窗: 1 year

In this study, the Edinburgh Postnatal Depression Scale was used to assess postpartum depressive symptoms. The scale consists of 10 items, each scored on a 4-point Likert scale (0-3). The total score ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms.

State-Trait Anxiety

时间窗: 1 year

In this study, the State-Trait Anxiety Inventory was used to assess anxiety levels. The scale consists of two subscales: state anxiety (STAI-S) and trait anxiety (STAI-T), each comprising 20 items. Items are rated on a 4-point Likert scale, and total scores for each subscale range from 20 to 80, with higher scores indicating greater levels of anxiety.

Neonatal Pain

时间窗: 1 year

In this study, the Neonatal Infant Pain Scale was used to assess pain in neonates. The scale consists of 6 items evaluating facial expression, cry, breathing patterns, arm and leg movements, and state of arousal. Each item is scored between 0 and 1, except for crying, which is scored between 0 and 2. The total score ranges from 0 to 7, with higher scores indicating greater pain intensity.

次要结局

  • Neurological Risk Level(1 year)

研究者

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

Müşerref Ebru YALÇIN

Principal Investigator

Inonu University

研究点 (1)

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