Exploring the Psychosomatic Factors Influencing and Moderating the Efficacy of Holistic Care and Personalized Treatment for Migraine Patients: A Prospective Longitudinal Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Effectiveness of acute medication
研究概览
简要总结
This research project aims at exploring the psychosomatic factors that influence and moderate the efficacy of holistic care and personalized treatment for migraine patients. It is a prospective longitudinal observational study. The project's goal is to understand how physical, psychological, spiritual, and social factors affect the care and treatment outcomes for migraineurs. The study will include participants aged 18 to 65, who meet the International Headache Society's criteria for migraines. It will utilize a range of methodologies including questionnaires, interviews, and medical records to collect data on various factors like lifestyle, psychological state, and social support. The project will assess the effectiveness of treatments, compliance, and other outcomes such as emotional and sleep conditions.
详细描述
In this study, participants will be recruited through clinics. All the participants will be asked to keep a migraine diary for the duration of three months. In addition to that, the participants will fill out questionnaires that measures depression, anxiety, well-being and migraine related disability. This study does not intervene with the routine clinical care. The investigators merely observe through participant's diary and other patient reports to find out about how psychological and social factors might lead to different clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •individuals aged between 18 and 65 who meet the International Headache Society's criteria for migraines
排除标准
- •incapacitate such as dementia or cognitive deficiency
- •illiterate, or could not sign informed consents
- •severe disorder or co-morbidities that the doctors advice against participation
结局指标
主要结局
Effectiveness of acute medication
时间窗: 3 months
The effectiveness of acute medication will be assessed by a 4-point scale measuring the degree of pain relief after medication administration, recorded in the migraine diary: 1. No effect at all 2. Minimal effect, headache slightly improved 3. Good effect, headache significantly improved 4. Very effective, pain completely resolved
Migraine attack duration
时间窗: 3 months
The duration of each migraine attack will be recorded in the migraine diary, measured in hours.
Migraine attack frequency
时间窗: 3 months
The frequency of migraine attacks will be assessed by the number of days with migraine attacks recorded in the migraine diary.
Migraine attack intensity
时间窗: 3 months
The intensity of migraine attacks will be assessed by the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
次要结局
- depression(3 months)
- anxiety(3 months)
- well-being(3 months)
- Compliance rate of migraine diary(3 months)
- Pain Resilience(3 months)
- Compliance rate of lifestyle modification(3 months)