NCT07392138

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Apr 2026May 2026

First Submitted

Initial submission to the registry

January 12, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

18 days

First QC Date

January 12, 2026

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physiological synchrony

    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 Outcomes (3)

  • Behavioral synchrony

    24 hours

  • Correlation between mother heart rate variability and depressive symptoms

    Duration of data collection varies from 1 to 4 weeks depending on the mother's decision.

  • Correlation between mother sleep and depressive symptoms.

    Duration of data collection varies from 1 to 4 weeks, depending on the mother's decision.

Study Arms (2)

Newborn

Other: Using monitoring devices

Mother

Other: Using monitoring devices

Interventions

During the data collection, mother and newborn are using the monitoring devices listed in study description.

MotherNewborn

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population consists of mother-newborn pairs.

You may qualify if:

  • ability to participate in Finnish
  • Android smart phone available
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

RECRUITING

Central Study Contacts

Anna Axelin, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2026

First Posted

February 6, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations