Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventr… (NCT02462434) | Clinical Trial Compass
CompletedNot Applicable
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
United States40 participantsStarted 2013-04
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in maternal State-Trait Anxiety Index scores
Timeframe: Up to 4 weeks
2
Change in maternal Beck Depression Index II scores
Timeframe: Up to 4 weeks
3
Change in maternal Brief Cope Inventory survey scores
Timeframe: Up to 4 weeks
4
Change in maternal PedsQL Family Impact Module survey scores