Participants have at least moderate levels of stress and/or pregnancy related anxiety Stress
Conditions
Interventions
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 pregn
(2) half of the participants of both groups are randomized into a wait-list control group.
Sponsors
Faculty of Psychology & Education,
Dept. of Developmental Psychology,
VU University, Van der Boechorststraat 1, 1081
BT Amsterdam
Eligibility
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 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)
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., betablockers), (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. Study2: See exclusion criteria women of study 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactA.C. Huizink
Dept. of Developmental Psychology VU University Van der Boechorststraat 1
Outcome results
None listed