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)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of Using HRVB Among Hospitalized Pregnant Women
研究概览
简要总结
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.
详细描述
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:
- To determine the feasibility of using HRVB among hospitalized pregnant women
- To measure the association between use of HRVB and maternal state anxiety.
- 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
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients are eligible for the study if they fulfill all the inclusion criteria specified below:
- •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
排除标准
- •Patients are not eligible for the study if they fulfill any of the exclusion criteria below:
- •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.
研究组 & 干预措施
Heart Rate Variability Biofeedback Tool
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.
干预措施: Heart Rate Variability Biofeedback Tool (Behavioral)
结局指标
主要结局
Feasibility of Using HRVB Among Hospitalized Pregnant Women
时间窗: 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)
The investigators will report rates of enrollment among women approached to join the study, rates of longitudinal data collection, and loss to follow-up.
次要结局
- Association Between HRVB and High-Frequency Heart Rate Variability (HF-HRV)(Baseline to in-patient follow-up (5 to 7 days in between))
- 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))
- 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))