Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine

NCT06334237 | Recruiting

• 1 other identifier: Y_113_0009
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

migraine; holistic care; personalized treatment

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Migraine attack duration

  The duration of each migraine attack will be recorded in the migraine diary, measured in hours.

  3 months

• 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: 1. No effect at all 2. Minimal effect, headache slightly improved 3. Good effect, headache significantly improved 4. Very effective, pain completely resolved

  3 months

Secondary Outcomes (6)

• Compliance rate of migraine diary

  3 months

• Compliance rate of lifestyle modification

  3 months

• depression

  3 months

• anxiety

  3 months

• well-being

  3 months

Interventions

personalized treatment OTHER

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. .

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

participants aged 18 to 65 who meet the International Headache Society's criteria for migraines.

You may qualify if:

• individuals aged between 18 and 65 who meet the International Headache Society's criteria for migraines

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Chang-hua, 500, Taiwan

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 27, 2024
• Study Start: April 18, 2024
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2026
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)