Effectiveness of Eye Mask and Noise Reduction Headset in Primary Headache

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Eye Mask and Noise Reduction Headset in Emergency Treatment of Primary Headache

Conditions
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Primary Headache Disorder

Intervention / Treatment
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* Other: mask
* Other: headset
* Other: standard drug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard drug<br>Standard treatment of primary headache with 10 mg metoclopramide IV in 150 ml saline given over 10 minutes | Other: standard drug<br>* investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes<br>|
| Active Comparator: drug mask<br>Standard treatment plus eye mask | Other: mask<br>* investigators will add eye mask to standard treatment<br>Other: standard drug<br>* investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes<br>|
| Active Comparator: drug headset<br>Standard treatment plus headset | Other: headset<br>* investigators will add headset to standard treatment<br>Other: standard drug<br>* investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes<br>|
| Active Comparator: drug mask headset<br>Standard treatment plus headset plus eye mask | Other: mask<br>* investigators will add eye mask to standard treatment<br>Other: headset<br>* investigators will add headset to standard treatment<br>Other: standard drug<br>* investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |