Clinical trial NCT06334237: Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine
Official title: Exploring the Psychosomatic Factors Influencing and Moderating the Efficacy of Holistic Care and Personalized Treatment for Migraine Patients: A Prospective Longitudinal Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: migraine
holistic care
personalized treatment
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants aged 18 to 65 who meet the International Headache Society's criteria for migraines.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Migraine attack frequency
timeFrame: 3 months
measure: Migraine attack intensity
timeFrame: 3 months
measure: Migraine attack duration
timeFrame: 3 months
measure: Effectiveness of acute medication
timeFrame: 3 months
Secondary outcomes:
measure: Compliance rate of migraine diary
timeFrame: 3 months
measure: Compliance rate of lifestyle modification
timeFrame: 3 months
measure: depression
timeFrame: 3 months
measure: anxiety
timeFrame: 3 months
measure: well-being
timeFrame: 3 months
measure: Pain Resilience
timeFrame: 3 months
Other outcomes:
Locations:
city: Chang Hua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
References: