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临床试验/NCT07392138
NCT07392138招募中不适用

Understanding Newborn-Mother Synchrony at Home: Feasibility of Remote Monitoring

University of Turku1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Physiological synchrony

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • , both (mother and newborn):
  • Not meeting the inclusion criteria

研究组 & 干预措施

Newborn

干预措施: Using monitoring devices (Other)

Mother

干预措施: Using monitoring devices (Other)

结局指标

主要结局

Physiological synchrony

时间窗: 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)).

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Axelin

Professor

University of Turku

研究点 (1)

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