Healthy pregnant woman or nursing mother
Conditions
Interventions
None listed
Sponsors
Hakodate Central General hospital
The Dai-ichi Life Insurance Co., Ltd Tech Doctor Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Subjects with no illness being treated at the time of informed consent (2) Females aged not less than 18 but less than 60 at the time of informed consent, who are in the second trimester or later of their first pregnancy (3) Subjects who have a smartphone terminal on which applications can be installed, with no plans to change the model during the research period, and who agree to the terms of use for the wearable device and application used in this research. (4) Subjects within 4 weeks before the expected delivery date or within 4 weeks after delivery (5) Subjects who have given written consent to participate in this study and to provide information for this study prior to participating in the study
Exclusion criteria
Exclusion criteria: (1) Subjects who have difficulty in health management in the perioperative period or due to infection, etc. (2) Subjects who judged by the principal investigator to have difficulty using a wearable device (3) Subjects who have any implanted device that can affect heart rate, such as a pacemaker (4) Subjects who have previously received any treatment for mental disorder such as depression (5) Subjects with a history of mental disorder such as depression (6) Subjects taking any drug that may affect heart rate (7) Subjects who may develop a skin rash due to continuous use of a wearable device (8) Others who are judged by the principal investigator to be inappropriate for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of stress-related values (heart rate variability) with the top 25% and bottom 25% of the Edinburgh Postnatal Depression Scale (EPDS) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Changes in stress-related values (heart rate variability) (2) Changes in physical activity (3) Changes in sleeping hour and sleep efficiency (4) Edinburgh Postnatal Depression Scale (EPDS) (5) Correlation coefficient between device data and scores for all information acquired via wearable device | — |
Countries
Japan
Contacts
Public ContactJun Ozawa
Satt Co.,Ltd Clinical Research Promotion Group
Outcome results
None listed