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临床试验/NCT04254718
NCT04254718已完成不适用

Preliminary Pilot Study of Digital Storytelling in the NICU

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年10月12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
6
试验地点
1
主要终点
Change in PROMIS Meaning and Purpose survey (short form)

研究概览

简要总结

Our long-term goal is to reduce suffering and long-term negative consequences for families in the Neonatal Intensive Care Unit (NICU). The overall purpose of this study is to test feasibility of a legacy intervention for NICU parents.

详细描述

Specific aims are:

(1) To determine the feasibility of a legacy intervention for NICU parents; and (2) to determine the feasibility of psychosocial instruments for NICU parents. We will recruit parents (N = 12) of 6 infants in the NICU who have received a palliative care consultation and expected to die by 1 year of age based on provider report. We will use a one-group pre- and post-test design. The intervention will be delivered by the PI or trained study staff conducting video-taped interviews with parents in private NICU rooms to create a digital story about their infant. The videographer will use the video and music selected by parents to create a digital story about the infant. The final digital story is provided to parents on a DVD or unlisted (private) YouTube link to keep. Parents will complete electronic psychosocial measures at enrollment (baseline/pre-intervention) and post-intervention.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Parents of infants in the NICU who have received a palliative care consult and expected to die by 1 year of age based on provider report:
  • •Parent caregivers (ages 18 years and up) of infants
  • •Parents will be defined as the legal guardians who act in the role of the infant's primary and secondary parent caregivers based on parent self-report.
  • •Able to speak and understand English
  • •Absence of cognitive impairment

排除标准

  • 未提供

研究组 & 干预措施

Digital Storytelling

Experimental

Legacy intervention via digital story for NICU parents

干预措施: Digital Storytelling (Behavioral)

结局指标

主要结局

Change in PROMIS Meaning and Purpose survey (short form)

时间窗: Baseline and 1 month

The PROMIS Meaning and Purpose survey assess one's sense of life having purpose and that there are good reasons for living. Scores range from 6-30. Higher scores indicated perceptions of hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.

Change in PROMIS Anxiety survey (short form)

时间窗: Baseline and 1 month

The PROMIS Anxiety (short form) survey measures the extent of anxiety. The range is 5-40, higher scores indicate higher anxiety

Change in Benefit Finding Scale

时间窗: Baseline and 1 month

Benefit Finding Scale measures the degree of deriving positive growth from adversity. Scores range from 17-85 with high scores indicating more positive growth.

Change in PROMIS Depression Survey (short form)

时间窗: Baseline and 1 month

The PROMIS Depression survey measures the extent of depression. The range is 5-40, with 5 being least depressed and 40 being the most depressed.

Change in PROMIS Sleep Disturbance survey (short form)

时间窗: Baseline and 1 month

The PROMIS Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Scores range from 4-20. Low scores indicate better sleep and high scores indicate worse sleep.

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

Terrah Akard

Associate Professor

Vanderbilt University

研究点 (1)

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