MigraineNCT06334237
Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine
An observational study of Migraine, run by Changhua Christian Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- personalized treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Apr 2024to 21 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: participants aged 18 to 65 who meet the International Headache Society's criteria for migraines.
Who may be able to join
- individuals aged between 18 and 65 who meet the International Headache Society's criteria for migraines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Changhua Christian Hospital
Chang-hua, 500
Yen-Yu Chen, MD, +886-4-7238595, 107281@cch.org.tw
About this study
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
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- personalized treatment
- Keywords
- migraine, holistic care, personalized treatment
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized treatmentOther
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. .
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine attack frequency
The frequency of migraine attacks will be assessed by the number of days with migraine attacks recorded in the migraine diary.
Measured: 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.
Measured: 3 months
Migraine attack duration
The duration of each migraine attack will be recorded in the migraine diary, measured in hours.
Measured: 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
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start18 Apr 2024
- Primary completion21 Feb 2025 (estimated)
- Study completion21 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334237
- Sponsor's protocol ID
- Y_113_0009
- Status last verified
- May 2024
- First submitted
- 1 Feb 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the research data contains medical records, we do not plan to share it.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06334237
- Acronym / sponsor ID
- Y_113_0009
- Conditions
- Migraine
- Keywords
- migraine, holistic care, personalized treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 21 Feb 2025 (estimated)
- Study completion
- 21 Feb 2026 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- participants aged 18 to 65 who meet the International Headache Society's criteria for migraines.
Key inclusion criteria (1 listed)
- individuals aged between 18 and 65 who meet the International Headache Society's criteria for migraines
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personalized treatmentAccording 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. . | Other | – |
Primary outcome
Migraine attack frequency
Time frame: 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
Time frame: 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.
Migraine attack duration
Time frame: 3 months
The duration of each migraine attack will be recorded in the migraine diary, measured in hours.
Effectiveness of acute medication
Time frame: 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
6 secondary outcomes
Compliance rate of migraine diary
Time frame: 3 months
Compliance rate of lifestyle modification
Time frame: 3 months
depression
Time frame: 3 months
anxiety
Time frame: 3 months
well-being
Time frame: 3 months
Pain Resilience
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No. Since the research data contains medical records, we do not plan to share it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine attack frequency (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.