Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine

Exploring the Psychosomatic Factors Influencing and Moderating the Efficacy of Holistic Care and Personalized Treatment for Migraine Patients: A Prospective Longitudinal Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: personalized treatment

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Taiwan
  • Chang Hua, Taiwan, 500
    • Recruiting
    • Changhua Christian Hospital
    • Contact: Yen-Yu Chen, MD; Phone Number: +886-4-7238595; Email: 107281@cch.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: No effect at all; Minimal effect, headache slightly improved; Good effect, headache significantly improved; Very effective, pain completely resolved	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): February 21, 2025
• Study Completion (Estimated): February 21, 2026

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: personalized treatment; migraine; holistic care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: Y_113_0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since the research data contains medical records, we do not plan to share it.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No