Feasibility of Heart Rate Variability Biofeedback With In-patient Pregnant Women

Background and Significance: Hospitalization during pregnancy is an unexpected interruption
in the prenatal period that causes increased maternal anxiety and stress(MacMullen 1992). In
a study of 129 women hospitalized for pregnancy complications, 25 met criteria for major
depressive disorder(Brandon 2008). Such maternal depression is a risk factor for perinatal
complications ranging from morbidity and mortality to neuropsychological developmental delays
in the offspring(Poehlmann 2001). To date, however, few easily disseminated strategies have
been identified to reduce stress among pregnant women.

To address this gap, the investigators plan a feasibility study of an easily-disseminated
biofeedback tool to reduce stress among hospitalized expecting mothers(Beckham 2013).
Converging evidence suggests that Heart Rate Variability Biofeedback (HRVB) can improve
stress management and executive functioning (Association for Applied Psychophysiology and
Biofeedback Inc 2011). Additionally, HRVB has recently been shown to reduce anxiety features
in women suffering from perinatal depression at UNC (Beckham 2013). The investigators
hypothesize that HRVB will reduce stress levels among expecting mothers hospitalized for
pregnancy complications, who are at high risk for depression and anxiety(Brandon 2008).

Objectives:

1. To determine the feasibility of using HRVB among hospitalized pregnant women

2. To measure the association between use of HRVB and maternal state anxiety.

3. To measure the association between use of HRVB, biological markers of stress, indexed by
salivary cortisol and oxytocin, and high frequency heart rate variability, measured
using research-quality instruments

4. To measure the effectiveness of HRVB in women with varying levels of clinical depression
and anxiety

Study Design & Methods: The investigators plan a pilot study to recruit 30 pregnant women who
are receiving care on the antepartum floor of the North Carolina Women's Hospital.

At the baseline session,the investigators will consent each participant and then screen her
for depression or anxiety. This screen will involve using the M.I.N.I Depression Module and
the Edinburgh Postnatal Depression Screen (EPDS). Both assessments will be scored at baseline
to determine if the participant has severe, moderate, or no clinical depression or anxiety.
The investigators will also record if the participant is on anxiety or depression medication
as apart of our screen. The investigators will also notes any medications given for other
mental illness.

Once this screen is complete, the investigators will collect sociodemographic information and
then proceed teach all the participants about biofeedback, how to use the HRVB device,
coupled with deep breathing techniques to detach from stressful thoughts. The HRVB
intervention will be administered by Carole Swanson, a registered nurse with extensive
experience in maternity care, will complete the HeartMath® Interventions Certification
Program(HeartMath LLC 2013). The certification provides detailed instruction on use of HRV
Biofeedback for clinical care. The HeartMath device, the EmWave2, uses a heart rate sensor on
the patient's earlobe to detect beat-to-beat variability, which is an index of vagal tone.
The device is attached to a laptop computer to allow the user to view visual cues for deep
breathing. The EmWave2 is currently used in clinical care in the inpatient psychiatry units
at UNC hospitals.

Before and after each HRVB session, participants will complete three measures of current
psychological distress (Spielberger State Anxiety Scale, Linear Analog Self Assessment,
Warwick-Edinburgh Mental Well-Being scale). To measure biologic markers of stress, the
investigators will collect saliva samples and measure blood pressure before and after
administering HRVB. In addition information on the participants' high frequency heart rate
variability will also be collected using the Single Channel 3991x Biolog, a research-quality
measure of heart rate variability.

Participants will then be instructed to practice their deep breathing exercises for
approximately ten minutes each day until the follow-up session and complete a brief log of
these exercises. During this period participants will also be asked to complete validated
inventories on perceived social support and life experiences (MOS Social Support Scale,
Maternal Antenatal Attachment Scale and Adverse Childhood Experiences). At the follow up
visit, approximately 5 to 7 days following the baseline session, administration of HRVB
inventories on maternal mood, the saliva sample and measurement of high frequency heart rate
variability will be repeated. The saliva sample will be used to measure salivary one or all
of the following: oxytocin, alpha-amylase, and cortisol.

Finally the investigators will attempt a follow-up call with each participant six to eight
weeks following discharge to measure continued use of HRVB techniques and satisfaction
qualitative information on HRVB feasibility.

Inclusion Criteria: Patients are eligible for the study if they fulfill all the inclusion
criteria specified below:

1. Patient has signed the informed consent before any study specific procedures are
performed.

2. Patient is a pregnant female over 18 years of age that is an in-patient on the UNC
Women's Hospital antepartum floor.

3. Patient agrees to adhere to study requirements

Exclusion Criteria: Patients are not eligible for the study if they fulfill any of the
exclusion criteria below:

1. Does not speak English.

2. Patient is not expected be on the antepartum floor of UNC Women's Hospital for at
least 7 days.

3. Patient's healthcare provider does not want the patient to participate for medical
safety purposes.