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NCT02462434 · ClinicalTrials.gov registry record · NA
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT02462434: Completed NA study, sponsored by University of Michigan.
NCT02462434 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02462434, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Mothers will complete the State-Trait Anxiety Index to assess current anxiety symptoms and trait-like anxiety symptoms (with clinical cut-off scores defined when applicable) at a prenatal follow up visit and again prior to neonatal surgery discharge.
Interventions
- BEHAVIORAL Early palliative care team consultation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-11-15 |
| Phase | NA |
What the finished NCT02462434 record still lists
NCT02462434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Early palliative care team consultation is the first listed.
NCT02462434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02462434 about?
NCT02462434 is a clinical study titled "Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology". 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 rece...
What is the current status of trial NCT02462434?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2013-04. Estimated completion is 2016-11-15.
What interventions are being tested in trial NCT02462434?
The interventions under investigation include: Early palliative care team consultation (BEHAVIORAL).
Who is sponsoring clinical trial NCT02462434?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02462434's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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