Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02462434
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2015-05-28
Brief Title:
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology Requiring Neonatal Surgery
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms coping and quality of lifefamily functioning in the care of neonates born with single ventricle physiology Half of the participants will receive early palliative care team consultation while the other half will receive usual care no or late palliative care intervention The investigators hypothesize maternal stress anxiety and depression will be lower in the palliative care intervention group compared with the control group and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment
Detailed Description:
Mothers of children with congenital heart disease are at increased risk of psychological morbidity including stress anxiety and depression In particular mothers of patients with single ventricle physiology who require neonatal surgery face a great deal of stress related to the risk of serious complications including neonatal death Previous studies have suggested that providing emotional psychosocial support may modify the development of significant psychosocial problems in parents of children with congenital heart disease The pediatric palliative care team specializes in multiple elements of psychological and spiritual care for families of such children
The purpose of this pilot study is to evaluate maternal psychological distress and to examine the potential impact of early palliative care team consultation on maternal anxiety and depression symptoms coping and quality of lifefamily functioning in the care of neonates born with single ventricle physiology Mothers will complete four questionnaires measuring anxiety depression and quality of lifefamily functioning at a prenatal follow up visit and again prior to neonatal surgical hospital stay discharge or at 30 days Infants will be randomly assigned by date of birth to receive early palliative care team consultation or usual care no or late palliative care intervention
The investigators hypothesize maternal stress anxiety and depression will be lower in the palliative care intervention group compared with the control group and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment
The purpose of this pilot study is to evaluate maternal psychological distress and to examine the potential impact of early palliative care team consultation on maternal anxiety and depression symptoms coping and quality of lifefamily functioning in the care of neonates born with single ventricle physiology Mothers will complete four questionnaires measuring anxiety depression and quality of lifefamily functioning at a prenatal follow up visit and again prior to neonatal surgical hospital stay discharge or at 30 days Infants will be randomly assigned by date of birth to receive early palliative care team consultation or usual care no or late palliative care intervention
The investigators hypothesize maternal stress anxiety and depression will be lower in the palliative care intervention group compared with the control group and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None