Migraine
Conditions
Interventions
The study will be carried out among school children in the Kandy District.
Participant allocation will be through stratified block randomization. A total of 12 schools will be selected using simple
Sponsors
Dr. S.M. Rathnasiri Bandara
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female school children 2. Age 16-19 years 3. Diagnosed with migraine according to the IHS-criteria ICHD-II 1.1: Migraine without aura [G43.0] 1.2: Migraine with aura [G43.1] 4. Complaint of a single migraine headache of moderate or severe intensity
Exclusion criteria
Exclusion criteria: 1. History of cranial lesion or tumor 2. Recent nasal or sinus infective illness, trauma and runny nose 3. Smoking 4. Known to abuse alcohol or drugs 5. Females on hormonal therapy for any condition or illness 6. Diagnosed psychiatric illness 7. Any other acute or chronic illness 8. Participants on non-medical/non-nutritional treatment for migraine prevention such as acupuncture or psychotherapy. 9. Participants on current medical treatment for acute migraine or migraine prophylaxis 10. Non-provision of informed consent and/or having lack of understanding of the information regarding the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Headache relief (defined as reduction of headache pain intensity from severe or moderate migraine headache to mild or none) at 60 seconds post-application of the device - using a 10 point pain scale and a 4 point Glaxo visual analogue scale. [At 60 seconds post-application of the device and at the completion of 1, 2, 4, 6, 12 and 24 hours post–application of the device] Change in severity of suborbital tenderness/ scalp tenderness due to migraine headache - - using a 10 point pain scale and a 4 point Glaxo visual analogue scale. [At 60 seconds post-application of the device and at the completion of 1, 2, 4, 6, 12 and 24 hours post–application of the device] | — |
Secondary
| Measure | Time frame |
|---|---|
| None [None] | — |
Contacts
Public ContactDr. S.M. Rathnasiri Bandara
Medical Officer
Outcome results
None listed