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

NCT02119936 | Terminated Results

• 1 other identifier: 13-2051
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Stress; Maternal Anxiety; Maternal Health Services

Keywords

Stress; Anxiety; Mental Health; Mental Health Services; Maternal Mental Health

Outcome Measures

Primary Outcomes (1)

• Feasibility of Using HRVB Among Hospitalized Pregnant Women

  The investigators will report rates of enrollment among women approached to join the study, rates of longitudinal data collection, and loss to follow-up.

  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 (5)

• Change in State-Trait Anxiety Inventory From Baseline to In-patient Follow up (5-7 Days).

  Baseline to in-patient follow-up (5 to 7 days in between)

• Association Between HRVB and High-Frequency Heart Rate Variability (HF-HRV)

  Baseline to in-patient follow-up (5 to 7 days in between)

• Correlation of HRVB Feedback With Varying Levels of Clinical Depression and Anxiety

  Baseline to in-patient follow-up (5 to 7 days in between)

• Change in Linear Analog Self-Assessment (LASA) From Baseline to In-patient Follow up (5-7 Days).

  Baseline to in-patient follow-up (5 to 7 days in between)

• Change in Warwick Edinburgh Mental Well Being Scale From Baseline to In-patient Follow up (5-7 Days).

  Baseline to in-patient follow-up (5 to 7 days in between)

Study Arms (1)

Heart Rate Variability Biofeedback Tool

EXPERIMENTAL

Intervention: Participants will be taught how to use the Heart Rate Variability Biofeedback tool (emWave 2) as a mechanism to reduce stress and anxiety, then use the tool, coupled with deep breathing exercises, to visualize their stress reduction.

Behavioral: Heart Rate Variability Biofeedback Tool

Interventions

Heart Rate Variability Biofeedback Tool BEHAVIORAL

The Heart Rate Variability Biofeedback tool (emWave 2) will capture heart rate variability (HRV) before and after deep breathing exercises are used among participants. Participants will be able to visualize changes in their HRV and then fill-out self-reported anxiety measures to determine if the breathing exercises and visualization of HRV affected anxiety.

Also known as: emWave 2 (Heartmath)

Heart Rate Variability Biofeedback Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has signed the informed consent before any study specific procedures are performed.
• Patient is a pregnant female over 18 years of age that is an in-patient on the UNC Women's Hospital antepartum floor.
• Patient agrees to adhere to study requirements

You may not qualify if:

• Does not speak English.
• Patient is not expected be on the antepartum floor of UNC Women's Hospital for at least 7 days.
• Patient's healthcare provider does not want the patient to participate for medical safety purposes.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27510, United States

Location

Related Publications (4)

• 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.

  PMID: 23179141 RESULT

• 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.

  PMID: 18312059 RESULT

• 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.

  PMID: 1295961 RESULT

• 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.

  PMID: 11346045 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Results Point of Contact

• Title: Holly Krohn
• Organization: UNC Chapel Hill

holly_krohn@med.unc.edu

919-445-0218

Study Officials

• Samantha Meltzer-Brody, MD, MPH

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 22, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 19, 2018
• Results First Posted: March 19, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)