NCT07392138 Understanding Newborn-Mother Synchrony at Home: Feasibility of Remote Monitoring
| NCT ID | NCT07392138 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Turku |
| Condition | Synchrony |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-04-13 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07392138 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, studying Synchrony. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07392138 currently recruiting?
Yes, NCT07392138 is actively recruiting participants. Contact the research team at anmaax@utu.fi for enrollment information.
Where is the NCT07392138 trial being conducted?
This trial is being conducted at Turku, Finland.
Who is sponsoring the NCT07392138 clinical trial?
NCT07392138 is sponsored by University of Turku. The trial plans to enroll 60 participants.