Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
Completed · Not applicable
Conditions studied: Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Single Ventricle Defect, Stress, Psychological
In brief
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 life/family 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.
Key facts
- Study ID
- NCT02462434
- Run by
- University of Michigan
- People needed
- 40
- Starts
- 2013-04-01
- Expected to finish
- 2016-11-15
- Last updated by the study team
- 2017-04-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Mothers pregnant with fetuses with single ventricle physiology who are planned to undergo staged single ventricle palliative surgery with the first surgery occurring in the neonatal period.
You may not qualify if…
- Mothers with neonates born at a gestational age of less than 32 weeks requiring admission and management in the Neonatal Intensive Care Unit.
- Mothers with neonates diagnosed with major non-cardiac congenital anomalies requiring additional surgical management beyond cardiac surgery in the neonatal period.
- Non-English-speaking mothers who are unable to adequately comprehend and respond to survey questions administered as part of this study.
Where it is running
- University of Michigan C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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