跳至主要内容
临床试验/NCT04389372
NCT04389372已完成4 期

Feasibility and Effectiveness of Mindfulness Program by Smartphone for Patients with Chronic Migraine and Medication Overuse During Covid-19 Emergency

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年12月15日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Efficacy of Mindfullness by Smartphone

研究概览

简要总结

Chronic Migraine is a disabling condition that affects the 2% of migraine population. It is often associated with medication overuse that makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse but it is also confirmed that patients have to be carefully followed in the last period after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. It has been also reported how the clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. Generally patients after withdrawal follow a specific prophylaxis for migraine, but also come weekly to the hospital for practicing mindfulness for 6 sessionsAs the emergency situation due to the Corona-virus pandemic phenomenon in Italy, patients will miss the possibility to come for the regular practice to the hospital: for this reason the investigator propose a small pilot study to enforce the use of technology for our patients so that they can continue to be followed in their therapeutic process. This preliminary study will be conducted on 25 patients that have been submitted to a withdrawal according to the standard procedure at our hospital and they will practice mindfulness daily by a standard session of 12 minutes on their smartphone recorded by the expert who generally manage their sessions at the hospital and also a weekly video-call to evaluate the clinical condition and to encourage to use strategies for pain management. This modality will allow the patients to continue their therapeutic process and to be followed regularly during the one year after withdrawal

详细描述

Background and significance Chronic Migraine is a disabling condition that affects the 2% of migraine population. It is often associated with medication overuse that makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse. Also, patients need to be carefully followed after withdrawal to avoid relapses in overuse and to improve the clinical benefit. It has been also reported that the clinical results can be improved if traditional therapies are combined with behavioral approaches in particular mindfulness, that help patients to become more conscious about their symptoms and able to manage pain without medication.

This preliminary study will be performed because the emergency for Covid-19 with the restrictions imposed will not allow patients. The literature of the last decades promote the use of smart phone or telemedicine for clinical and therapeutic application with encouraging results. Twenty five patients that have been submitted to a withdrawal according to the standard procedure at our hospital will practice mindfulness daily by a standard session of 12 minutes on their smartphone recorded by the expert who generally manage their sessions at the hospital. Also a weekly video-call to evaluate the clinical condition and to encourage to use strategies for pain management will be scheduled.

This modality will allow the patients to continue their therapeutic process and to be followed regularly during the one year after withdrawal

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Years age >18 yrs
  • clinical diagnosis of Chronic Migraine with medication Overuse
  • withdrawal treatment at the Besta institute
  • written informed consent

排除标准

  • 未提供

结局指标

主要结局

Efficacy of Mindfullness by Smartphone

时间窗: at 6 months and 12 months follow-up compared with baseline (Headache Daily Diary)

Changes in migraine /days per month and medication intake/month (decrease of at least 50% in at least 50% of CM-MO patients)

次要结局

  • Change in Quality of life(6months - 12 months)
  • Change of Disability Score(6months - 12months)

研究者

发起方
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验