Anxiety, Pregnancy, Stress
Conditions
Keywords
Owlet, Pregnancy, Digital Health, Wellness
Brief summary
This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.
Detailed description
The Owlet Band is a wellness product (similar to a fitbit), it is not designed to be a medical device. The study involves women age 18 and older who are currently pregnant, at least 24 weeks' gestation or later, and who live in the USA. Up to 8,000 pregnant women are expected to participate in the study. This study will involve review of Owlet Band data and participant responses to questionnaires throughout the study. The purpose of this research is to observe if using the new Owlet Band and the associated iPhone app can help pregnant women in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant, while still maintaining their standard medical care.
Interventions
OTHEROwlet Band
The Owlet Band is a wearable fabric band pregnancy tracker made up of small sensors that are able to detect natural low-level electrical signals normally produced by the mother's heart and baby's (fetal) heart.
Sponsors
Owlet Baby Care, Inc.
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be at least 24 weeks pregnant with a singleton pregnancy * Must be at least 18 years of age * Must currently live in the United States * Must have a compatible smartphone (Apple iOS Version 13 or above) * Able to read and understand English in order to provide Informed Consent and follow study instructions
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gather information | From date of enrollment until the date of reported delivery or early termination , whichever came first, assessed up to 16 weeks | Successful collection of Owlet Band data from study participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Management of anxiety State Trait Anxiety Inventory | Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days) | Change in anxiety as assessed by State Trait Anxiety Inventory (STAI) |
| Management of stress (Perceived Stress Scale) | Participant completion of the PSS questionnaire before wearing the Owlet Band and at Day 31 and Day 52 (+3 days) | Change in perceived stress as assessed by Perceived Stress Scale (PSS) |
| Participant's experience while using the Owlet Band | Through study completion, up to 16 weeks | Self-report of bonding and connection |
| Maintenance of standard medical care | Through study completion, up to 16 weeks | Self-Report of standard medical care and unexpected or unscheduled visits |
Countries
United States
Contacts
Primary ContactMadison Kenley, BS, CCRC
Backup ContactKenneth Ward, MD
Outcome results
None listed