Department of Neuromedicine and Movement Science, NTNU Norwegian University of Science and Technology, Trondheim, Norway.
National Advisory Unit on Headaches, Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.
Headache. 2020 May;60(5):889-901. doi: 10.1111/head.13772. Epub 2020 Feb 13.
The objective of this study was to develop and investigate the usability of a biofeedback treatment smartphone app for adolescent migraine sufferers.
Biofeedback is effective in treating pediatric migraine. However, biofeedback is not widely used due to the necessity of a trained therapist and specialized equipment. Emerging digital technology, including smartphones and wearables, enables new ways of administering biofeedback.
In a prospective open-label development and usability study, 10 adolescent migraine sufferers used a newly developed biofeedback app with wearable sensors that measured their muscle tension, finger temperature, and heart rate. Three iterative rounds of usability testing, including a 2-week home testing period, were completed. A biofeedback algorithm, combining and optimizing the 3 physiological modalities, and several algorithms for sham-treatment were created. Usability was evaluated statistically and summarized thematically.
Five of ten participants completed all 3 rounds of usability testing. A total of 72 biofeedback sessions were completed. Usability scoring was consistently high, with median scores ranging from 3.5 to 4.5 on a 5-point scale. The biofeedback optimization algorithm correlated excellently to the raw physiological measurements (r = 0.85, P < .001). The intervention was safe and tolerable.
We developed an app for young migraine sufferers to receive therapist-independent biofeedback. The app underwent a rigorous development process as well as usability and feasibility testing. It is now ready for clinical trials.
本研究旨在开发并研究一种适用于青少年偏头痛患者的生物反馈治疗智能手机应用的可用性。
生物反馈在治疗儿童偏头痛方面是有效的。然而，由于需要经过培训的治疗师和专门设备，生物反馈并未得到广泛应用。新兴的数字技术，包括智能手机和可穿戴设备，为生物反馈的实施提供了新途径。
在一项前瞻性、开放性的开发和可用性研究中，10 名青少年偏头痛患者使用了一种新开发的生物反馈应用程序，该应用程序配备了可测量肌肉紧张度、手指温度和心率的可穿戴传感器。完成了三轮迭代的可用性测试，包括为期两周的家庭测试期。创建了一种生物反馈算法，结合和优化了 3 种生理模式，以及几种用于假治疗的算法。通过统计方法评估了可用性，并进行了主题总结。
共有 10 名参与者中的 5 名完成了所有 3 轮可用性测试。共完成了 72 次生物反馈治疗。可用性评分一直很高，在 5 分制中中位数评分为 3.5 至 4.5 分。生物反馈优化算法与原始生理测量值相关性极好（r = 0.85，P <.001）。干预措施安全且耐受良好。
我们为年轻的偏头痛患者开发了一款可接受独立治疗师的生物反馈应用程序。该应用程序经过了严格的开发过程以及可用性和可行性测试，现已准备好进行临床试验。
