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Trial record 61 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Impact of a Neonatal-Bereavement-Support DVD on Grief

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ClinicalTrials.gov Identifier: NCT01926080
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : August 20, 2013
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Grief Depressive Symptoms Other: DVD Intervention Arm Not Applicable

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'.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: End-of-Life Care in the NICU: Does Bereavement Support Make a Difference?
Study Start Date : January 2008
Actual Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Arm Intervention/treatment
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.
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.

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926080


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01926080     History of Changes
Other Study ID Numbers: 201108060
P30CA091842 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

Keywords provided by Washington University School of Medicine:
Depression
Spirituality
Neonatal death
Bereavement
Randomized controlled trial

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms