Digital Storytelling in the NICU

Bereavement Clinical Trial

Official title:

Preliminary Pilot Study of Digital Storytelling in the NICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254718
• Other study ID #: 191469
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bereavement

Intervention

Behavioral:
• Digital Storytelling
Creation of a digital story about the infant with video and music selected by parents

Locations

Country	Name	City	State
United States	Vanderbilt University	Nolensville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PROMIS Anxiety survey (short form)	The PROMIS Anxiety (short form) survey measures the extent of anxiety. The range is 5-40, higher scores indicate higher anxiety	Baseline and 1 month
Primary	Change in PROMIS Depression Survey (short form)	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.	Baseline and 1 month
Primary	Change in PROMIS Sleep Disturbance survey (short form)	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.	Baseline and 1 month
Primary	Change in PROMIS Meaning and Purpose survey (short form)	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.	Baseline and 1 month
Primary	Change in Benefit Finding Scale	Benefit Finding Scale measures the degree of deriving positive growth from adversity. Scores range from 17-85 with high scores indicating more positive growth.	Baseline and 1 month