Migraine endpoints are counted from diary days. This template asks one question on a headache-free day and the full set on a headache day: timing, worst pain, the features that classify a migraine day, acute medication and possible triggers.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Headache diary · Today
Subject 002-0031 · Baseline day 17 · Demo study
Did you have a headache today?
When did it start?
Worst pain today
Which of these did you have?
Medicine taken for this headache
At a glance
Design
A preventive migraine trial asks people to record every day for months, and most of those days have no headache. If a headache-free day takes as long as a migraine day, completion drops and missing days start to look like good days. Skip logic solves it: "Did you have a headache today?" is the only question when the answer is no, and a yes opens the rest of the entry.
The questions on a headache day follow ICHD-3. For migraine without aura, ICHD-3 looks for at least two of four pain characteristics (one-sided, pulsating, moderate or severe, worse with or causing avoidance of routine activity) and at least one of nausea or vomiting, or sensitivity to both light and sound. The diary asks about each feature in plain words, one per option, so the analysis can test the criteria rather than relying on the participant's own label of "migraine".
The IHS guidelines rate peak pain on a four-level scale (none, mild, moderate, severe), with an 11-point numeric rating as an alternative or addition. Pick one before the baseline starts and keep it for the whole study. The EDC for migraine clinical trials page covers endpoints, baseline eligibility and acute treatment designs in more depth.
This template is a daily diary for prevention trials. Acute treatment trials instead record one treated attack at fixed time points after dosing (for example 2 hours for pain freedom). Build that as a separate attack form with a time question for the dose and a scale for pain at each time point, so the two do not get mixed.
Template
One entry per calendar day, completed in the evening. Fields after the first appear only on headache days.
| Field | Question type | Values | Why it is there |
|---|---|---|---|
| Headache today | Single choice | No, yes | Gate question; "no" ends the entry |
| Start time | Time | hh:mm | Duration for the 30-minute and 4-hour rules |
| Still going at bedtime | Single choice | No, yes | Carries a long attack into the next day's entry |
| End time | Time | hh:mm | Asked when the headache has ended |
| Worst pain | Single choice | Mild, moderate, severe (or 0 to 10 numeric) | Moderate or severe headache days |
| Pain features | Multiple choice | One side, throbbing, worse with activity | ICHD-3 pain characteristics |
| Associated symptoms | Multiple choice | Nausea, vomiting, light, sound | ICHD-3 associated symptoms |
| Aura before or during | Single choice | No, yes, not sure | Separates migraine with aura |
| Acute medicine taken | Multiple choice | Triptan, gepant or ditan, ergot, simple painkiller, combination painkiller, opioid, none | Migraine-specific treatment and overuse by class |
| Number of doses today | Numeric | 0 to 10 | Doses per day without a repeating table |
| Did the medicine help | Single choice | No, partly, fully | Response to migraine-specific medication |
| Menstruating today | Single choice | Yes, no, not applicable | Menstrual association (optional) |
| Possible triggers | Multiple choice | Poor sleep, stress, missed meal, alcohol, weather, other | Exploratory, never an endpoint by default |
ePRO diaries use the 10 standard question types. Repeating table rows are an eCRF feature, so the diary counts doses per day instead of logging each dose as a row.
Timing
The diary starts at the beginning of the baseline period and runs every day until the end of follow-up. Eligibility usually depends on baseline counts (for example a minimum number of migraine days and a minimum share of completed diary days), so the baseline diary has to be the same form as the treatment-period diary.
Set one daily task with a completion window that closes the following morning, so yesterday can still be recorded but last week cannot. Reminders go out by email or SMS with a secure link that opens in the phone browser, and the reminder ladder stops as soon as the entry is done. The compliance view shows participants who are missing days, so the site can call before a baseline fails on completion.
| Assessment | Scr | Baseline | M1 | M2 | M3 | FU |
|---|---|---|---|---|---|---|
| Daily headache diary | D | D | D | D | D | |
| Eligibility from baseline counts | ||||||
| Impact questionnaire (separate licence) | ||||||
| Adverse events and con meds (site) |
D = one diary entry per day; baseline is 4 weeks
Build the diary in the free sandbox, then enter a headache-free day and a migraine day to see how long each takes.
Data quality
Migraine days, moderate or severe headache days and acute medication days are derived values. Capture's calculated fields cover a fixed set of clinical formulas, so these counts are produced in analysis from the export, using rules written into the protocol and statistical analysis plan: what counts as a day, how an attack crossing midnight is split, whether a headache treated early with a triptan counts as a migraine day, and how missing days are handled in the monthly denominator.
Because the features are separate coded answers and every entry carries a timestamp in the field-level audit trail, those rules can be applied consistently and checked. A late entry is visible as late, and a correction keeps the old value, the new value and the reason. For a medication-overuse check, count days with any acute medicine and days with each class over each 30-day window; ICHD-3 describes medication-overuse headache as headache on 15 or more days a month with regular overuse for more than 3 months, at 10 or more days a month for triptans, ergots, opioids and combination analgesics, or 15 or more for simple analgesics.
ICHD-3 links menstrual migraine to attacks starting between 2 days before and 3 days after the first day of menstruation in at least two of three cycles, and recommends a prospective diary for research. A daily "menstruating today" question gives the analysis what it needs. Make it optional and explain why it is asked in the consent form.
MIDAS, HIT-6 and the Migraine-Specific Quality of Life Questionnaire are published instruments with their own copyright and terms. Get permission from each rights holder and build them as separate questionnaires on visit days. On participant questionnaires, Capture lets you record the licence number, holder and expiry; it does not verify licences or supply the wording.
Adapt it
Migraine day, moderate or severe day and acute medication day defined in the protocol.
Four-level categorical, 0 to 10 numeric, or both, fixed for the study.
Classes and local brand examples in the help text.
Closes the next morning; late entries handled by your rule.
Minimum migraine days and minimum diary completion stated.
Permission obtained, built as their own questionnaires.
Whether a headache occurred, start and end time, worst pain, the pain features and associated symptoms used by ICHD-3, aura, acute medicine taken by class and dose count, response, menstruation and possible triggers.
The International Headache Society guidelines for preventive episodic migraine trials strongly recommend an electronic diary with timestamps and remote monitoring; paper is described as less desirable.
No. It records the features as structured answers, and the migraine-day rule from your protocol is applied in analysis so every day is classified the same way.
Record acute medicine by class every headache day, then count acute medication days per 30-day window against the ICHD-3 thresholds of 10 or 15 days a month depending on the class.
No. They are separate copyrighted instruments. Obtain permission from the rights holders and add them as their own questionnaires on visit days.
Yes. It is a generic diary, so you can build it in the free sandbox with no credit card and pay only when you go live with real participants.
Keep exploring
EDC for migraine trials
Endpoints and baseline design.
Pain diary template
General daily pain diary.
Numeric pain rating scale
The 0 to 10 alternative.
Patient diary software
Daily diaries at scale.
EDC for CNS and neurology trials
Neurology studies.
Concomitant medications eCRF
Preventive and background drugs.
A daily diary with skip logic, timestamps and reminders, next to your site data. Free sandbox, no credit card, pay only when live.