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

NCT02119936 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-03-19

Study results available
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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

Interventions

BEHAVIORAL

Heart Rate Variability Biofeedback Tool

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.

Sponsors & Collaborators

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Samantha Meltzer-Brody, MD, MPH · UNC-Chapel Hill

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02119936 on ClinicalTrials.gov