Clinical trial NCT02119936: Feasibility of Heart Rate Variability Biofeedback With In-patient Pregnant Women
Official title: Feasibility of Heart Rate Variability Biofeedback as a Stress Reduction Tool for Hospitalized Pregnant Women at the University of North Carolina at Chapel Hill (UNC-CH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Maternal Stress
Maternal Anxiety
Maternal Health Services
Keywords: Stress
Anxiety
Mental Health
Mental Health Services
Maternal Mental Health
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2014-04-22
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: The investigators plan a feasibility study on an easily disseminated biofeedback tool to reduce stress among hospitalized and expecting mothers. Converging evident suggests that Heart Rate Variability Biofeedback (HRVB) can improve the threshold of stress management and improve executive functioning. Additionally HRVB has been shown to significantly reduce anxiety features in women suffering from perinatal depression. 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.

Participants: Expecting mothers hospitalized for pregnancy complication, who are at high risk for depression and anxiety.

Procedures: The investigators plain to use a heart rate variability biofeedback tool to measure stress reduction in hospitalized expectant mothers. This tool will be coupled with validated surveys and scales, high frequency heart rate variability, saliva samples, and qualitative interviews to quantify the reduction in stress from the HRVB tool.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Using HRVB Among Hospitalized Pregnant Women
timeFrame: Baseline, in-patient follow-up (5 to 7 days after baseline), and follow-up phone call (6 to 8 weeks post in-patient follow-up)
Secondary outcomes:
measure: Change in State-Trait Anxiety Inventory From Baseline to In-patient Follow up (5-7 Days).
timeFrame: Baseline to in-patient follow-up (5 to 7 days in between)
measure: Association Between HRVB and High-Frequency Heart Rate Variability (HF-HRV)
timeFrame: Baseline to in-patient follow-up (5 to 7 days in between)
measure: Correlation of HRVB Feedback With Varying Levels of Clinical Depression and Anxiety
timeFrame: Baseline to in-patient follow-up (5 to 7 days in between)
measure: Change in Linear Analog Self-Assessment (LASA) From Baseline to In-patient Follow up (5-7 Days).
timeFrame: Baseline to in-patient follow-up (5 to 7 days in between)
measure: Change in Warwick Edinburgh Mental Well Being Scale From Baseline to In-patient Follow up (5-7 Days).
timeFrame: Baseline to in-patient follow-up (5 to 7 days in between)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Samantha Meltzer-Brody, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beckham AJ, Greene TB, Meltzer-Brody S. A pilot study of heart rate variability biofeedback therapy in the treatment of perinatal depression on a specialized perinatal psychiatry inpatient unit. Arch Womens Ment Health. 2013 Feb;16(1):59-65. doi: 10.1007/s00737-012-0318-7. Epub 2012 Nov 25.
citation: Brandon AR, Trivedi MH, Hynan LS, Miltenberger PD, Labat DB, Rifkin JB, Stringer CA. Prenatal depression in women hospitalized for obstetric risk. J Clin Psychiatry. 2008 Apr;69(4):635-43. doi: 10.4088/jcp.v69n0417.
citation: MacMullen N, Dulski LA, Pappalardo B. Antepartum vulnerability: stress, coping, and a patient support group. J Perinat Neonatal Nurs. 1992 Dec;6(3):15-25. doi: 10.1097/00005237-199212000-00004. No abstract available.
citation: Poehlmann J, Fiese BH. The interaction of maternal and infant vulnerabilities on developing attachment relationships. Dev Psychopathol. 2001 Winter;13(1):1-11. doi: 10.1017/s0954579401001018.