Pregnancy And Infancy Reduced Stress 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 several populations, and is expected to be effective in stressed pregnant
women as well. 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 examine the effect of stress reduction through heart rate variability (HRV)
biofeedback + psycho-education (condition 1) in pregnant women with at least
moderate levels of stress, and their partners, as compared to
psycho-educational coaching only (reference condition), on: (a) physiological
and subjective measures of stress, anxiety and well-being for pregnant women
and their partners, (b) birth outcomes for mother and child, and (c) infant
behaviour, development, and well-being (study 1).

Secundary objectives:
(1) To examine the changes in HRV-biofeedback parameters across pregnancy (due
to changes in total blood volume)(study 2).
(2) To test and validate a device for ambulatory monitoring of stress
physiology against the well-validated and commonly used VU-AMS research device
(study 1).
(3) To test the effects of HRV-biofeedback on diverted attention (study 2).

This study consists of two randomized controlled trails.

Study 1:
Pregnant women, together with their partners or a significant other, are
randomized to either (1) HRV-biofeedback + psycho-educational training or (2)
psycho-education training only (reference condition). Our study further
includes repeated measures of determinants and outcomes during pregnancy and
the first year of life of the infant. In short, repeated measures of outcomes
during pregnancy (stress indices, medical complications, sleep quality; T1 and
T2), at birth (T3: gestational age, birth weight, delivery and birth
complications) and the first year of life at 1 (T4; parental adaptation and
stress indices), 6 & 12 months (T5 & T6: infant behaviour, development,
emotional well-being; parental adaptation and family functioning) will be
conducted. Participation in the study will, therefore, take about 1.5 years.

Study 2:
Pregnant and non-pregnant women are randomized to either a
Biofeedback-immediate group, or a Biofeedback-waitlist group (reference
condition), resulting in four groups: (1) Biofeedback-immediate, pregnant; (2)
Biofeedback-immediate, non-pregnant; (3) Biofeedback-waitlist, pregnant; and
(4) Biofeedback-waitlist, non-pregnant. The study further includes repeated
measures of stress indices, sleep quality and attention. In the
Biofeedback-immediate condition these measurements take place before and after
the training, and six weeks later (follow-up). In the Biofeedback-waitlist
condition, the first two measurements take place before the training, with a
six week period in between, and the third measurement takes place after the
training.

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 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 will 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.

Study 1:
There are no risks anticipated for women, partners, and their (unborn) child
with the study. Burden for the pregnant women and their partners consists of
participating in the intervention, filling out questionnaires, and
physiological measurements. Burden for the child consists of mental and
physical development measurements.

During the intervention, the pregnant women and their partners are asked to
come to our research facility in Amsterdam for nine weekly group sessions of
2-2.5 hours each, with max. 40 min/day of home practice and diary reports
during these weeks.
Both the pregnant women and their partners are asked to fill out questionnaires
twice during pregnancy (approx. 60 minutes per set of questionnaires) and three
times during the first year following birth (approx. 30-40 minutes per set of
questionnaires). Questionnaires can be filled out at home.

For the physiological measurements during pregnancy, the pregnant women and
their partners are asked to visit our research facility in Amsterdam twice. It
will take about 60-90 minutes to complete these measurements.

The child born from this pregnancy is tested two times on mental and physical
development during the first year (at 6 months and 1 year; 45-60 minutes for
each measurement). For these measurements, at least one of the parents is asked
to visit our research facility in Amsterdam with the child.

Study 2:
There are no risks anticipated for the participants. Burden for the
participants consists of participating in the intervention, filling out
questionnaires, and physiological measurements.

During the intervention, participants are asked to come to our research
facility in Amsterdam for five weekly group sessions of 60-90 minutes each,
with 30-40 min/day of home practice and diary reports during these weeks.
Participants will be asked to fill out questionnaires three times (approx.
25-40 minutes for each set of questionnaires). This can be done at home. For
the measurements of the HRV parameters, the participants are asked to visit our
research facility in Amsterdam. It will take about 30-40 minutes to complete
these measurements. Furthermore, an emotional interference tasks is applied
three times, when participants are at our research facility. In this task,
participants are presented with pictures from the widely used International
Affective Picture System (IAPS), and some of the pictures contain an image that
can be experienced as unpleasant (e.g., accidents). This task will take about
15 minutes to complete.