Effectiveness of Eye Mask and Noise Reduction Headset in Primary Headache

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Headache Disorder
• Intervention / Treatment: Other: standard drug; Other: mask; Other: headset

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • AnkaraCHBilkent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Gül Pamukçu Günaydın, MD, Ankara Yildirim Beyazit University Faculty of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): October 10, 2022
• Study Completion (Anticipated): November 15, 2022

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders; Headache Disorders, Primary
• Other Study ID Numbers: AYBU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No