Pregnancy And Infancy Reduced Stress (PAIRS)
study.

There is accumulating evidence that prenatal maternal stress and anxiety may result in less optimal birth outcomes and has long-lasting adverse consequences on offspring’s development and behavior. Therefore, reducing maternal stress and anxiety during pregnancy is of major importance, because it will provide a fundament for a healthy
child development.



A heart rate variability (HRV) biofeedback intervention has been proven to be effective in reducing stress and to increase adaptation to stressful situations in various populations, and is expected to be also effective in stressed pregnant women. Recent research shows the importance of social support by their spouse and the major impact of the transition to parenthood for both women and men in their relationship. Therefore, we ask the spouses to participate in the intervention study as well.



Although several studies have shown that HRV-biofeedback can serve as a stress and anxiety reducing intervention, little is known about the mechanisms of this technique. One hypothesis is that blood volume is related to certain HRV-biofeedback parameters. In pregnant women, blood volume increases in a relatively short time, which makes this specific group an ideal population to study this relationship.

A possible mechanism that may contribute to the reduction of stress and anxiety via HRV-biofeedback is learning to focus and shift, i.e., regulate, your attention. To test this hypothesis, an emotional interference task is included in this study.



Primary Objective: To assess whether HRV-biofeedback can provide an additional stress reducing effect to psycho-educational coaching in pregnant women with at least moderate levels of stress, and their partners, that influences the development of the child as shown by: (a) physiological and subjective measures of stress and anxiety during pregnancy for pregnant women and their partners, (b) birth outcomes for mother and child, and (c) physical, cognitive, and social-emotional development of the infant (Study 1).



Secondary Objectives: (1) To examine the changes in HRV-biofeedback parameters across pregnancy (due to changes in total blood volume); (2) To test the effects of HRV-biofeedback on diverted attention (Study 2).

Study 1:

T1: 16 wks pregnant

T2: 26 wks pregnant

T3: 1 wk after birth

T4: infant 1 month old

T5: infant is 6 mos old

T6: infant is 12 mos old



Everyday Problem List (Daily hassles; T1 & T2); Pregnancy Related Anxieties Questionnaire-Revised (T1 & T2); Pregnancy Experience Scale (T1 & T2); Dyadic Coping Inventory (Marital satisfaction; T1 & T2); Partnership Questionnaire (T1 & T2); Penn State Worry Questionnaire (T1 & T2); Perceived Stress Scale (T1&T2, T4-T6); Depression, Anxiety, Stress Scale (T1&T2, T4-T6); Pittsburgh Sleep Quality Index (T1&T2, T4-T6); Utrecht Coping List (T1 & T2); Attentional Control Scale (T1&T2, T4-T6); Scales of Psychological Well-being (T1&T2, T4-T6); Self-Efficacy in the Nurturing Role Questionnaire (parental self-efficacy; T1&T2, T4-T6); Pregnancy complications and obstetric information (T3); Birth measures including gestational age at birth, birth weight, APGAR scores, method of delivery (spontaneously, forceps, primary/secondary caesarean section), complications at delivery (fetal distress, oxygen supply, infection, neonatal intensive care needed, time spent in incubator) (T3); Infant health including duration of feeding, infant height and weight, illnesses, and medication use (T3-T6); Infant Behavior including measures of infant crying, development of sleep/wake cycles (T4-T6); Infant Behavior Questionnaire - Revised (temperament; T5 & T6); Infant Developmental Inventory (T4-T6); Bayley Scales of Infant and Toddler Development - Third Edition (T5 & T6); General Functioning subscale of the Family Assessment Device (T6); Comprehensive Parenting Behavior Questionnaire (parenting style; T4-T6)



Study 2:

All questionnaires are filled out at three time points with six weeks intervals: pre-intervention, post-intervention and follow-up (Biofeedback-immediate condition); or two times before the intervention and ones after the intervention (Biofeedback-waitlist condition)



Perceived Stress Scale; Depression, Anxiety, Stress Scale; Everyday Problem List (Daily hassles); Pregnancy Related Anxieties Questionnaire-Revised (pregnant women only); Pittsburgh Sleep Quality Index; Utrecht Coping List; Attentional Control Scale; Scales of Psychological Well-being; Rosenberg Self Esteem Scale; Mastery Scale

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.