Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Netherlands Trial Register
Year
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2014
INTERVENTION: Study 1: Two intervention conditions are part of the study: (1) HRV‐biofeedback + psycho‐education, and (2) psycho‐education (reference condition). The psycho‐education consists of an extensive pregnancy course for couples, called 'Samen Bevallen'. Each condition consists of 9 weekly group sessions + 1 reunion session after birth of 2‐2.5 hours, starting in mid‐pregnancy. Groups consist of 6 pregnant women and their partners, led by a well‐educated midwife‐trainer. Both conditions require daily homework practices (max. 40 min.) for participants. Study 2: The heart rate variability biofeedback intervention consists of 5 weekly group sessions of 60‐90 minutes, with daily home practices (40 minutes). Groups consist of 6 participants There are two types of control in study 2: (1) a group of non‐pregnant women serves as a control for the pregnant women; (2) half of the participants of both groups are randomized into a wait‐list control group. CONDITION: Stress, Delivering women, Pregnancy, Anxiety ; ; PRIMARY OUTCOME: Study 1:; ; (a) Perceived stress, anxiety and well‐being (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 OUTCOME: Study 2: ; ; HRV biofeedback parameters (e.g. heart rate, heart rate variability, RSA); perceived stress, anxiety and well‐being assessed by means of self‐report on validated questionnaires; diverted attention 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 < 22 weeks pregnant. They should have at least moderate levels of prenatal stress, determined by a score of 22 or higher on the PSS (mean score derived from Cohen & Janicki‐Deverts, 2012), or a score of 21 or higher on the PRAQ‐R (mean score derived from unpublished data from the Generations2 study of VU university). Partners should be >18 years of age. Study 2: In order to be eligible to participate in this study, a subject must meet all of the following criteria: For pregnant women see ‘Study 1’ above. The non‐pregnant women need to have comparable ages, relevant for matching purposes, and should have at least moderate levels of stress, determined by a score of 22 or higher on the PSS (mean score derived from Cohen & Janicki‐Deverts, 2012)
Epistemonikos ID: 403bb268f2f76f71fcac6da32d83dc861bc771c7
First added on: Aug 23, 2024