Clinical trial NCT04178252: Effectiveness of Eye Mask and Headset in Primary Headache
Official title: Effectiveness of Eye Mask and Noise Reduction Headset in Emergency Treatment of Primary Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Headache Disorder
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: change in pain
timeFrame: 30 min
measure: change in pain
timeFrame: 60 min
Secondary outcomes:
measure: need for rescue analgesic drug
timeFrame: 60 min
measure: preference of method over standard treatment
timeFrame: 60 min
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: AnkaraCHBilkent
Study officials:
affiliation: Ankara Yildirim Beyazit University Faculty of Medicine
name: Gül Pamukçu Günaydın, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 2016 Sep 13.
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.
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.