Maternal Health Services Clinical Trial
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)
Verified date | May 2017 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | October 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | UNC-Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | North Carolina Translational and Clinical Sciences Institute |
United States,
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/ — View 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. — View 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. — View Citation
Poehlmann J, Fiese BH. The interaction of maternal and infant vulnerabilities on developing attachment relationships. Dev Psychopathol. 2001 Winter;13(1):1-11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in State-Trait Anxiety Inventory From Baseline to In-patient Follow up (5-7 Days). | State-trait anxiety scores range from 40-80 with higher scores indicative of greater anxiety | Baseline to in-patient follow-up (5 to 7 days in between) | |
Secondary | Association Between HRVB and High-Frequency Heart Rate Variability (HF-HRV) | The investigators will measure HF-HRV in 1-minute segments during HRVB, and will test whether coherence score, as recorded by the HRVB device, correlates with HF-HRV. | Baseline to in-patient follow-up (5 to 7 days in between) | |
Secondary | Correlation of HRVB Feedback With Varying Levels of Clinical Depression and Anxiety | The investigators will stratify our population based on the depression screen used at the baseline visit. These groups will include those with severe, moderate, or lack of depression. The investigators will then compare these groups to the finds from the surveys on maternal mood and the difference noticed among the groups due to the HRVB tools. | Baseline to in-patient follow-up (5 to 7 days in between) | |
Secondary | Change in Linear Analog Self-Assessment (LASA) From Baseline to In-patient Follow up (5-7 Days). | The Linear Analog Self-Assessment (LASA) form measures patient quality-of-life. Scores range from 6-30 with higher scores indicative of greater well-being. | Baseline to in-patient follow-up (5 to 7 days in between) | |
Secondary | Change in Warwick Edinburgh Mental Well Being Scale From Baseline to In-patient Follow up (5-7 Days). | The Warwick Edinburgh Mental Well Being Scale is a 14 item self-report measure assessing subjective well-being (1-5 scale). Higher values represent more positive mental well being. The summary measure is a sum of the 14 questions (not a mean). Summary values therefore range from 14-70. | Baseline to in-patient follow-up (5 to 7 days in between) |
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