Expectancies About Positive Outcomes and Their Possible Potentiating Role of Standard Treatment in Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Headache Impact Test
研究概览
简要总结
The aim of the present study is to examine whether the standard treatment prescribed to migraine patients is potentiated when coupled with a verbal instruction inducing more hope and optimism. In order to achieve the goal, outpatients with low-frequency episodic migraine diagnoses (<8 attacks per month) and outpatients with chronic migraine diagnoses (>15 attacks per month) will be screened and enrolled, thereafter they will be exposed to verbal instruction inducing more hope and optimism or to verbal instruction inducing hope and optimism together with standard treatment. We hypothesize that the group receiving verbal instruction inducing more hope and optimism would develop larger improvements in all outcome measures.
详细描述
Study design and sample Cohort study with longitudinal detection of the endpoints of interest for the study (See section "Instruments").
Among the new patients or outpatients already assisted at the SOD Center Headache and Clinical Pharmacology of the University Hospital (AOU) Careggi, the candidates eligible for participation will be identified according to the inclusion and exclusion criteria listed below and participation will be proposed. Patients who, after being informed will consent through explicit and written informed consent to participate in the study, will be enrolled. A total of 100 subjects will be enrolled. Each participant will be able to withdraw the consent for participation at any time without providing justification. The request will invariably be accepted, and the subject's data will be excluded from the study.
Inclusion criteria for cases:
- Incident or prevalent diagnosis of low-frequency episodic migraine or chronic migraine according to ICHD criteria version 3 beta 2013.
- Age of at least 18 years.
- Signature of informed consent.
Exclusion criteria for cases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
participants did not know whether they were allocated to the control or the experimental condition
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incident or prevalent diagnosis of low-frequency episodic migraine or chronic migraine according to ICHD criteria version 3 beta
- •Age of at least 18 years.
- •Signature of informed consent.
排除标准
- •Standard treatment proposed different from topiramate, amitriptyline, valproate, β-blockers.
- •Inability to understand and want.
结局指标
主要结局
Headache Impact Test
时间窗: baseline, 7-day, 15-day, 1- and 3-month follow-ups
self-report scale assessing the disability due to migraine
Intensity of migraine
时间窗: baseline, 7-day, 15-day, 1- and 3-month follow-ups
A Numeric Rating Scale (NRS) assessing the intensity of migraine pain on a 11-point NRS (0 = no pain, 10 = worst imaginable pain) during the last migraine attack
次要结局
- Expectancies(baseline, 7-day, 15-day, 1- and 3-month follow-ups)
研究者
Fiammetta Cosci
Professor
University of Florence