A Pilot Single-center Randomized Controlled Study of the Effects of Smartphone Based Heart Rate Variability Biofeedback in People With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life
研究概览
简要总结
This is a two arm study comparing smartphone based heart rate variability biofeedback using the HeartMath app and InnerBalance sensor to waitlist control on migraine quality of life.
详细描述
The primary objective of this study is to determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life. Investigators will also look:
- To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in depression in people with migraine.
- To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in anxiety in people with migraine.
- To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in insomnia in people with migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •International Classification of Headache Disorders (ICHD) 3 criteria for migraine
- •4-20 headache days/month
- •Has not done behavioral therapy for migraine in the past year
- •Has a smartphone and willing to try HRV biofeedback using an app and ear monitor
- •English speaking
- •HS graduate or higher level of education
- •Patients must not make preventive medication changes for the course of the study. If patients just changed their preventive medication, they must wait a month before enrolling.
排除标准
- •Doing any form of behavioral therapy for pain in the past year
研究组 & 干预措施
HeartMath
干预措施: HeartMath (Behavioral)
Waitlist Control
干预措施: HeartMath (Behavioral)
Waitlist Control
干预措施: Waitlist Control (Behavioral)
结局指标
主要结局
To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life
时间窗: 8 Weeks
Measured by comparing the slope of reduction in MSQv2 scores
次要结局
- Change insomnia(8 Weeks)
- Change in anxiety(8 Weeks)
- Change in depression(8 Weeks)