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NCT04559620 · ClinicalTrials.gov registry record · NA
Mother's Recorded Voice for Preterm Infants
A NA study, sponsored by AdventHealth.
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
NCT04559620 is a NA study that has completed, run by AdventHealth. The registered enrollment target is 67 participants.
The verdict
NCT04559620, a NA study, has completed, sponsored by AdventHealth.
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
Study Summary
The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can feel tremendous guilt whenever they are unable to be present at their baby's bedside. The investigators believe that giving parents an opportunity to provide comfort in the form of the mother's voice, pre-recorded and played to her baby, will improve her feeling about her baby in the NICU. The investigators hypothesize that playing the mother's recorded voice to her extremely preterm infant while in the incubator when she cannot be present will improve the depression, anxiety and stress as well as overall feeling about her baby. The investigators will assess the change in depression, anxiety and stress with the use of a validated tool (the DASS21), as a result of the intervention. The investigators will also assess the improvement of her feelings with a questionnaire () to be administered before and after the intervention. The investigators predict that her depression, anxiety and stress as well as positive feeling will increase after the intervention. The investigators also predict that the infant's vital signs will remain stable and/or improve when the recording is played.
Interventions
- OTHER Maternal voice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2021-03-25 |
| Est. Completion | 2024-01-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04559620
The ClinicalTrials.gov registry entry for NCT04559620 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AdventHealth, which has 95 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Maternal voice is the first listed.
NCT04559620 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04559620 about?
NCT04559620 is a clinical study titled "Mother's Recorded Voice for Preterm Infants". The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can fee...
What is the current status of trial NCT04559620?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2021-03-25. Estimated completion is 2024-01-09.
What interventions are being tested in trial NCT04559620?
The interventions under investigation include: Maternal voice (OTHER).
Who is sponsoring clinical trial NCT04559620?
This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.
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