Educational Video Program to Promote Physical Activity and Reduce Migraine Frequency in Adults Wi… (NCT06993545) | Clinical Trial Compass
CompletedNot Applicable
Educational Video Program to Promote Physical Activity and Reduce Migraine Frequency in Adults With Migraine
Portugal307 participantsStarted 2024-04-22
Plain-language summary
The goal of this clinical trial is to learn if an educational video program can help reduce migraine frequency and improve migraine-related outcomes in adults with migraine. The main questions it aims to answer are:
* Does the video-based intervention reduce the number of monthly migraine episodes?
* Does it reduce the use of acute migraine medication?
* Does it increase the physical activity levels?
Researchers will compare participants who watch educational videos about physical activity with participants who receive usual care, to see if the intervention has additional benefits.
Participants will:
* Be randomly assigned to one of two groups: intervention or control
* The intervention group will watch seven short educational videos over a period of 3 months
* All participants will complete questionnaires before and after the intervention period to assess migraine impact, frequency, medication use, and physical activity levels
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older
* Diagnosis of episodic or chronic migraine confirmed by a neurologist, based on the 3rd edition of the International Classification of Headache Disorders (ICHD-3)
* Willing and able to participate in the study
Exclusion Criteria:
* Inability to read or understand the study materials
* Inability or unwillingness to collaborate with study procedures
* Refusal to participate
* Diagnosis of other primary headache disorders (except for medication overuse headache)
* Presence of substance use disorders
* Presence of chronic medical conditions that limit physical activity (e.g., rheumatic diseases, systemic inflammatory conditions, neoplastic diseases)
* Presence of severe psychiatric disorders
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Headache Impact Test (HIT-6) score from baseline to 6-month follow-up
Timeframe: HIT-6 scores were collected at baseline (T0) and at 6-month follow-up (T6), corresponding to three months after the completion of the video-based intervention.