Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine

Recruiting

• Conditions: Migraine

• Registration Number: NCT06334237
• Lead Sponsor: Changhua Christian Hospital

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.

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-27
• Study Start: 2024-04-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-02-21
• Study Completion: 2026-02-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Migraine attack duration	3 months	The duration of each migraine attack will be recorded in the migraine diary, measured in hours.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Chang Hua, Taiwan