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临床试验/NCT04331925
NCT04331925已完成不适用

Impact of Journal Program on Wellbeing of NICU Parents

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2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
100
试验地点
1
主要终点
Change in HADS anxiety score

研究概览

简要总结

The purpose of this study is to investigate the impact of a journaling program on rates of anxiety and depression in neonatal intensive care unit (NICU) parents.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Mother, father, and/or legal guardian of infant
  • •> 28 weeks gestation
  • •At least 5 days anticipated admission in Vanderbilt NICU

排除标准

  • •< 28 weeks gestation
  • •Expected death or discharge within 5 days of admission
  • •Primary medical team feels that participation would be disruptive or detrimental to infant's care

研究组 & 干预措施

Anxiety and depression screening

Other

Hospital Anxiety and Depression Scale (HADS) questionnaire administered at the start of the study. After two weeks or at the time of discharge, participants will complete the HADS questionnaire again

干预措施: Anxiety and depression screening (Behavioral)

Anxiety and depression screening

Other

Hospital Anxiety and Depression Scale (HADS) questionnaire administered at the start of the study. After two weeks or at the time of discharge, participants will complete the HADS questionnaire again

干预措施: Journaling (Behavioral)

Anxiety and depression screening with journaling

Experimental

Parents randomized into the intervention group be given verbal instructions to use a journal how/when they choose for the duration of the intervention period. They will also complete the HADS questionnaire before and after the intervention period of two weeks. At the end of the intervention period, these parents will also complete a survey regarding their experience with journaling

干预措施: Journaling (Behavioral)

结局指标

主要结局

Change in HADS anxiety score

时间窗: Baseline to 2-4 weeks

The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. The range of scores for anxiety is 0 to 21. A score of 0 is no anxiety. A score of 1-7 indicates some anxiety. A score of greater than or equal to 8 is the cut-off for clinical anxiety.

Change in HADS depression score

时间窗: Baseline to 2-4 weeks

The HADS is a fourteen item scale that generates: Seven of the items relate to depression and seven relate to anxiety. The range of scores for depression is 0 to 21. A score of 0 is no depression. A score of 1-7 indicates some depression. A score of greater than or equal to 8 is the cut-off for clinical depression.

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

Laura Shashy

Clinical Fellow

Vanderbilt University Medical Center

研究点 (1)

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