Migraine
Conditions
Keywords
migraine, holistic care, personalized treatment
Brief summary
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.
Detailed description
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.
Interventions
According to the condition of each individuals, the study continues their routine clinical care. The study does not offer anything more than a routine clinical care. It is named personalized treatment because the condition of each individual varies, so the doctor may prescribe or offer clinical advice accordingly. .
Sponsors
Changhua Christian Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
* individuals aged between 18 and 65 who meet the International Headache Society's criteria for migraines
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migraine attack frequency | 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 | 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. |
| Migraine attack duration | 3 months | The duration of each migraine attack will be recorded in the migraine diary, measured in hours. |
| Effectiveness of acute medication | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| well-being | 3 months | Well-being will be assessed by the Flourishing Scale. The scale ranges from 8 to 56, with higher scores indicating greater psychological well-being. |
| Compliance rate of migraine diary | 3 months | The compliance rate of migraine diary will be calculated as the percentage of days with appropriately completed diary entries out of the total days of participation. |
| Pain Resilience | 3 months | Pain resilience will be assessed by the Pain Resilience Scale (PRS). The scale ranges from 0 to 56, with higher scores indicating greater resilience to pain. |
| Compliance rate of lifestyle modification | 3 months | The compliance rate of lifestyle modification will be assessed by self-reported adherence to recommended changes (e.g., sleeping time, or exercising) in the migraine diary. |
| depression | 3 months | Depression will be assessed by the Patient Health Questionnaire-9 (PHQ-9). The scale ranges from 0 to 27, with higher scores indicating more severe depression. |
| anxiety | 3 months | Anxiety will be assessed by the Generalized Anxiety Disorder-7 (GAD-7). The scale ranges from 0 to 21, with higher scores indicating more severe anxiety. |
Countries
Taiwan
Outcome results
None listed