Impact of a Neonatal-Bereavement-Support DVD on Grief

NCT ID: NCT01926080

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2017-08-09

Brief Summary

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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.

Detailed Description

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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'.

Conditions

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Grief Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

DVD Intervention Arm

Intervention Type OTHER

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Rosenbaum JL, Smith JR, Yan Y, Abram N, Jeffe DB. Impact of a Neonatal-Bereavement-Support DVD on Parental Grief: A Randomized Controlled Trial. Death Stud. 2015 Jan-Jun;39(1-5):191-200. doi: 10.1080/07481187.2014.946628. Epub 2014 Dec 20.

Reference Type DERIVED
PMID: 25530502 (View on PubMed)

Other Identifiers

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P30CA091842

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201108060

Identifier Type: -

Identifier Source: org_study_id

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