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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04178252
Other study ID # AYBU1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 8, 2020
Est. completion date November 15, 2022

Study information

Verified date October 2022
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
mask
investigators will add eye mask to standard treatment
headset
investigators will add headset to standard treatment
standard drug
investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes

Locations

Country Name City State
Turkey AnkaraCHBilkent Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

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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