Bereavement Clinical Trial
Official title:
Preliminary Pilot Study of Digital Storytelling in the NICU
NCT number | NCT04254718 |
Other study ID # | 191469 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 12, 2020 |
Est. completion date | June 30, 2021 |
Verified date | September 2021 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nolensville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
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 |
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