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Completed

NCT Number: NCT04254718

Digital Storytelling in the NICU

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.

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Key information

Conditions

Bereavement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nolensville, Tennessee, 37135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Digital Storytelling

Behavioral

Creation of a digital story about the infant with video and music selected by parents

Primary outcomes

  1. Change in PROMIS Anxiety survey (short form)

    Time frame: 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

  2. Change in PROMIS Depression Survey (short form)

    Time frame: 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.

  3. Change in PROMIS Sleep Disturbance survey (short form)

    Time frame: 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.

  4. Change in PROMIS Meaning and Purpose survey (short form)

    Time frame: 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.

  5. Change in Benefit Finding Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Preliminary Pilot Study of Digital Storytelling in the NICU

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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