- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01926080
Impact of a Neonatal-Bereavement-Support DVD on Grief
August 16, 2013 updated by: Washington University School of Medicine
End-of-Life Care in the NICU: Does Bereavement Support Make a Difference?
Experts agree that neonatal death has long-term impact on parents.
Many parents experience sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child.
There are no prospective studies that evaluate the effectiveness of bereavement management and follow-up on the grief process following the death of a newborn.
The purpose of this study is to evaluate the impact of a neonatal intensive care unit (NICU) bereavement support program and the use of a newly designed family-centered bereavement DVD.
This educational DVD includes personal interviews with parents, grandparents and siblings who have experienced the lost of a baby in the NICU.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The care given to a family before and following a neonatal loss can set the stage for a family's entire grieving process.
For many parents, the support they receive from health care providers after the loss of a baby may have crucial effects on the family's ability to appropriately respond.
It is essential for nurses, practitioners, physicians, and chaplains to provide compassionate care that meets or exceeds parents' expectations.
However, supporting families following the death of an infant is particularly challenging.
There is limited bereavement intervention guidance in the literature that may benefit grieving parents.
Follow-up care is a crucial part of bereavement management of families whose babies have died.
The bereavement committee at St. Louis Children's Hospital (SLCH) is a multi-disciplinary team, which includes representation from neonatal nurses and nurse practitioners, neonatologists, social workers, chaplains, patient-care associates, and former bereaved parents.
Their role is to assist families both at the time of an infant's death and in securing their baby's personal belongings after the family leaves the hospital.
In addition to receiving bereavement materials, which is considered standard-practice of care in the NICU at SLCH following the death of an infant, half of the parents enrolled in the study will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'.
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 18 years of age
- Any parent who has experienced the death of a baby in the NICU at SLCH or has had a baby treated in the NICU who has died at home with hospice care
Exclusion Criteria:
- Babies who are at home longer than one month with hospice care will be excluded
- Those who are not English speaking or who are illiterate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: DVD Intervention Arm
Half of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'.
A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group.
|
Half of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'.
A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group.
|
No Intervention: Standard Bereavement Care
Those randomized to control group (no DVD) Standard Bereavement Care Arm receive the bereavement materials given to families as standard-practice of care in the NICU at SLCH following the death of an infant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental Grief
Time Frame: 3 and 12 months following death of a newborn
|
To characterize and describe changes in grief at 3 months and 12 months in a cohort of parents who have experienced death of a newborn infant in the NICU.
|
3 and 12 months following death of a newborn
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive Mood Symptoms
Time Frame: 3 and 12 months following death of a newborn
|
To characterize and describe changes in depressive mood symptoms at 3 months and 12 months in a cohort of parents who have experienced death of a newborn infant in the NICU.
|
3 and 12 months following death of a newborn
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
August 16, 2013
First Submitted That Met QC Criteria
August 16, 2013
First Posted (Estimate)
August 20, 2013
Study Record Updates
Last Update Posted (Estimate)
August 20, 2013
Last Update Submitted That Met QC Criteria
August 16, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201108060
- P30CA091842 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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