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Pregnancy And Infancy Reduced Stress study

Pregnancy And Infancy Reduced Stress study - PAIRS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40370
Enrollment
560
Registered
2014-03-19
Start date
2014-05-19
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Verhoogd risico op stress en stressgerelateerde klachten Stress tension

Interventions

Study 1: Two intervention conditions are part of the study: (1) HRV-biofeedback + psycho-education, and (2) psycho-education (reference condition). Each condition will consist of 9 weekly group ses

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Study 1: In order to be eligible to participate in this study, a subject must meet all of the following criteria: The pregnant women should be >18 years of age, and

Exclusion criteria

Exclusion criteria: Study 1 A potential subject (pregnant woman) who meets any of the following criteria will be excluded from participation in this study: (1) chronic medical conditions such as Diabetes, (2) use of medication which is known to affect cardiovascular stress reactivity measures (e.g., * blockers), (3) substance abuse, (4) insufficient command of the Dutch language required to fill out questionnaires, (5) a score of 16 or higher on the depression scale of the HADS (cut-off score for severe depression), and (6) presence of a history of other severe mental disorders, such as Bipolar disorder or Schizophrenia.;If the partner of the pregnant woman meets any of the following criteria, the couple will be excluded from participation in this study: (1) presence of a history of other severe mental disorders, such as Bipolar disorder or Schizophrenia, (2) substance abuse, (3) insufficient command of the Dutch language required to fill out questionnaires.;Study 2 See exclusion criteria women of study 1.

Design outcomes

Primary

MeasureTime frame
Numbering corresponds to numbering *Primary Objective* (a) Perceived stress and anxiety (pregnant women and their partners) assessed by means of self-report on validated questionnaires; stress physiology of parameters of the autonomic nervous system (e.g. heart rate, heart rate variability, pre-ejection period, respiratory sinus arrhythmia, skin conductance responses) as measured by basal functioning and by responses to a standardized stress task; (b) Medical complications during pregnancy; birth outcomes for the mother and child with regard to: gestational age, birth weight, APGAR scores (1-5 minutes), method of delivery, complications; (c) Infant behaviour and development: sleep patterns, feeding patterns, crying, infant temperament, motor and mental development.

Secondary

MeasureTime frame
Numbering corresponds to numbering *Secundary Objectives* (1) HRV-biofeedback parameters (related to changes in total blood volume). (2) Usability and validity of the DTI-2. (3) Diverted attention, using an emotional interference task.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)