Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Sickle Cell Patients: Pilot Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Patient Reported Outcomes Measurement Information System (PROMIS) Measures
研究概览
简要总结
This study will test the hypothesis that Heart Rate Variability Biofeedback (HRV-B) restores autonomic balance and reduces pain and other symptoms among patients with sickle cell disease (SCD).The specific aims of this study are to: (1) conduct a randomized, wait list controlled, pilot intervention trial to determine whether HRV-B increases HRV coherence among SCD participants (minimum N of 30, up to 50 total); (2) determine whether HRV-B reduces pain, stress, fatigue, depression or insomnia among SCD participants; and (3) determine whether increases in HRV coherence are associated improvements in pain, stress, fatigue, depression, or sleep among study participants.
详细描述
The purpose of this study is to see if Heart Rate Variability Biofeedback (HRV-B) can reduce chronic pain, stress, depression, anxiety, insomnia, loneliness, helplessness, physical limitations and pain medication dependence. HRV-B is an interactive procedure in which participants relax and breathe regularly while watching a computer screen. The computer screen provides feedback that helps people increase their heart rate variability, which is the difference from beat to beat. HRV-B is a complementary, non-pharmacologic therapy that is now being used to see if it can help sickle cell patients reduce their symptoms of pain, stress, insomnia, fatigue, or depression.
Participants will be randomly assigned to either an Intervention Group or a Comparison Group. Each group will have about 15-20 participants. The Intervention group will receive a baseline assessment including symptom questionnaires, up to six weekly HRV-B training sessions lasting about 45 minutes each, and a follow-up assessment including symptom questionnaires. There are 6-8 total visits for the intervention group and 2 for the control group. The Comparison Group will have a baseline assessment including symptom questionnaires, then six weeks with no training sessions, then a follow up assessment including symptom questionnaires. After the follow up assessment, the Comparison Group members will have the option of receiving the same treatment as the Intervention Group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCD patients
- •10 years old
- •English literate
- •Patient recruited through Greenville Health System
- •Any race or ethnicity
排除标准
- •Conditions affecting HRV (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina)
- •Medications that affect cardiac rhythm (angiotensin converting enzyme, calcium channel, or beta-adrenergic inhibitors)
- •Pacemaker or defibrillator
- •Heart transplant or by-pass surgery within 1 year
- •Active seizure disorder or use of antiseizure/anticonvulsant medication specifically for seizures
- •Moderate or severe head injury or stroke within 6 months
- •Evidence of active substance abuse
- •An uncontrolled major psychiatric disorder
- •Cognitive disability that precludes participation
- •Use of long acting (extended release) opioid medications; however, 'as needed' short acting opioid medication usage is allowable
结局指标
主要结局
Patient Reported Outcomes Measurement Information System (PROMIS) Measures
时间窗: 4-6 weeks
A comprehensive survey of physical function, anxiety, sleep disturbance, depression, fatigue, social roles, pain interference, and pain intensity are completed before the study begins and upon completion. Each domain is measured with a separate short form consisting of eight questions, with the exception of pain intensity, which is measured as a raw score of zero to ten. The scores of these surveys are combined. This number is then converted to a single PROMIS measure T score metric.
次要结局
- C-Reactive Protein in saliva(4-6 weeks)
- Sleep Quality(4-6 weeks)