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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06334237
Other study ID # Y_113_0009
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 18, 2024
Est. completion date February 21, 2026

Study information

Verified date May 2024
Source Changhua Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date February 21, 2026
Est. primary completion date February 21, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
personalized treatment
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. .

Locations

Country Name City State
Taiwan Changhua Christian Hospital Chang Hua

Sponsors (1)

Lead Sponsor Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Migraine attack frequency The frequency of migraine attacks will be assessed by the number of days with migraine attacks recorded in the migraine diary. 3 months
Primary Migraine attack intensity 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. 3 months
Primary Migraine attack duration The duration of each migraine attack will be recorded in the migraine diary, measured in hours. 3 months
Primary Effectiveness of acute medication 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:
No effect at all
Minimal effect, headache slightly improved
Good effect, headache significantly improved
Very effective, pain completely resolved
3 months
Secondary Compliance rate of migraine diary 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. 3 months
Secondary Compliance rate of lifestyle modification 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. 3 months
Secondary depression 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. 3 months
Secondary anxiety 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. 3 months
Secondary well-being Well-being will be assessed by the Flourishing Scale. The scale ranges from 8 to 56, with higher scores indicating greater psychological well-being. 3 months
Secondary Pain Resilience 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. 3 months
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