Primary Headache Disorder Clinical Trial
Official title:
Effectiveness of Eye Mask and Noise Reduction Headset in Emergency Treatment of Primary Headache
Verified date | October 2022 |
Source | Ankara City Hospital Bilkent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary headache can be triggered by light or noise. Getting rest in a quiet and dark environment for the treatment of acute headache is recommended for relief of pain during an attack. It is hard to provide this kind of environment in a busy emergency department. We aimed to determine if eye masks and noise reduction head sets are effective in reducing pain scores, fastening pain relief when used together with standard care. We also aimed to see if these methods were preferred over standard care.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | November 15, 2022 |
Est. primary completion date | October 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients with current headache as a chief complaint presenting to Emergency Department - triage category 3,4,5. - preliminary clinical diagnosis of primary headache is made after brief history and physical exam by the attending emergency physician according to International Classification of Headache disorders version 3 - the attending physician ordered IV treatment Exclusion Criteria: - pregnant - known or suspected diagnosis of a secondary etiology of headache at presentation or at any point during the Emergency Department visit - head trauma within 14 days - inability comply with the study due to insufficient knowledge of Turkish language - known allergy to standard treatment or rescue treatment - history of GI bleeding in the last year - taking any analgesic drug in the last four hours or taking the maximum dose of standard treatment before coming to Emergency Department - hepatic or renal failure - patients with hearing or vision loss |
Country | Name | City | State |
---|---|---|---|
Turkey | AnkaraCHBilkent | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara City Hospital Bilkent |
Turkey,
Anagnostou E, Vikelis M, Tzavellas E, Ghika A, Kouzi I, Evdokimidis I, Kararizou E. Photophobia in primary headaches, in essential blepharospasm and in major depression. Int J Neurosci. 2017 Aug;127(8):673-679. doi: 10.1080/00207454.2016.1231185. Epub 201 — View Citation
Oktay C, Eken C, Goksu E, Dora B. Contribution of verbal suggestion to the therapeutic efficacy of an analgesic agent for acute primary headache. Cephalalgia. 2015 Jun;35(7):579-84. doi: 10.1177/0333102414553821. Epub 2014 Oct 10. — View Citation
Wang J, Huang Q, Li N, Tan G, Chen L, Zhou J. Triggers of migraine and tension-type headache in China: a clinic-based survey. Eur J Neurol. 2013 Apr;20(4):689-96. doi: 10.1111/ene.12039. Epub 2013 Jan 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in pain | Change in pain measured by visual analogue scale from baseline measurement achieved at min 0. Investigators will use a 100mm visual analogue scale in which 0 represents no pain and 100 mm represents worse pain ever | 30 min | |
Primary | change in pain | Change in pain measured by visual analogue scale from baseline measurement achieved at min 0. Investigators will use a 100mm visual analogue scale in which 0 represents no pain and 100 mm represents worse pain ever | 60 min | |
Secondary | need for rescue analgesic drug | Patients will be asked in one question if they need any additional analgesic or if they are comfortable enough. If a patients wants additional analgesics, regardless of their pain score measured by Visual analogue scale he/she will be given dexketoprofen | 60 min | |
Secondary | preference of method over standard treatment | Patients will be asked in one question if they will prefer the method of treatment that they received in the study in case they have headache in the future | 60 min |
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