- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07392138
Understanding Newborn-Mother Synchrony at Home: Feasibility of Remote Monitoring
Parents and newborns influence each other in a dynamic interaction that can be described as synchrony. Synchrony between a newborn and mother refers to the dynamic and reciprocal adaptation between the newborn and mother. In this synchrony, the mother is highly receptive and sensitive to the newborn's signals, feelings, and needs. The aim of this study is to investigate the physiological and behavioral synchrony between newborns and their mothers, and to investigate the connection between maternal heart rate variability and postpartum depression symptoms in the home environment and to evaluate the suitability of remote monitoring devices for use in the home environment.
The study participants consist of 30 newborns and 30 mothers. The inclusion criteria for newborns are: 1) informed consent from the newborn's parents/guardians 2) the newborn's health status has been confirmed as normal during hospital monitoring, and 3) the newborn is less than one month old. The inclusion criteria for mothers are: 1) ability to participate in Finnish, and 2) the mother has access to an Android smartphone.
Data collection will be carried out using the following remote monitoring methods: Emfit smart mattress, Zoundream Cry analyses technology, Polar Verity Sense sensor, and Empatica EmbracePlus sensor. In addition, data will be collected using background information forms, a maternal stress scale (PSS-4), a diary completed by the mother, a maternal depression questionnaire (EPDS), and questionnaires measuring the suitability of remote monitoring in the home environment, and a thematic interview. In addition, at the end of the data collection phase, the mothers participating in the study will try out the Companion App, which displays sample data on the well-being of newborns, and respond to a questionnaire on the usability of the app.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anna Axelin, Professor
- Phone Number: +358405029905
- Email: anmaax@utu.fi
Study Locations
-
-
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Turku, Finland
- Recruiting
- Turku University Hospital
-
Contact:
- Anna Axelin, Professor
- Phone Number: +358405029905
- Email: anmaax@utu.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria, mothers:
- ability to participate in Finnish
- Android smart phone available
Inclusion Criteria, newborns:
- received informed consent from both parents/guardians
- the newborn's health has been stated normal during hospital stay
- the newborn is < 1-month of age
Exclusion Criteria, both (mother and newborn):
Not meeting the inclusion criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Newborn
|
During the data collection, mother and newborn are using the monitoring devices listed in study description.
|
|
Mother
|
During the data collection, mother and newborn are using the monitoring devices listed in study description.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physiological synchrony
Time Frame: 24 hours
|
Measuring correlation between mother heart rate (mHR (unit: BPM)) and heart rate variability (mHRV (unit ms)) and newborn heart rate (bHR (unit: BPM)) and heart rate variability (bHRV (unit: ms)).
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral synchrony
Time Frame: 24 hours
|
Measuring the correlation between mother total sleep duration and duration of different sleep stages and newborn total sleep duration and duration of sleep stages (unit: hours and minutes).
|
24 hours
|
|
Correlation between mother heart rate variability and depressive symptoms
Time Frame: Duration of data collection varies from 1 to 4 weeks depending on the mother's decision.
|
Measuring the correlation between mother heart rate variability (mHRV (units: ms)) and depressive symptoms (points from EPDS scale).
|
Duration of data collection varies from 1 to 4 weeks depending on the mother's decision.
|
|
Correlation between mother sleep and depressive symptoms.
Time Frame: Duration of data collection varies from 1 to 4 weeks, depending on the mother's decision.
|
Measuring the correlation between the duration of mother sleep stages (unit: hours and minutes) and depressive symptoms (points from EPDS scale).
|
Duration of data collection varies from 1 to 4 weeks, depending on the mother's decision.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- #476745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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