Effectiveness of Eye Mask and Headset in Primary Headache

NCT04178252 | Completed

• 1 other identifier: AYBU1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Headache Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• need for rescue analgesic drug

  60 min

• preference of method over standard treatment

  60 min

Study Arms (4)

standard drug

ACTIVE COMPARATOR

Standard treatment of primary headache with 10 mg metoclopramide IV in 150 ml saline given over 10 minutes

Other: standard drug

drug mask

ACTIVE COMPARATOR

Standard treatment plus eye mask

Other: mask; Other: standard drug

drug headset

ACTIVE COMPARATOR

Standard treatment plus headset

Other: headset; Other: standard drug

drug mask headset

ACTIVE COMPARATOR

Standard treatment plus headset plus eye mask

Other: mask; Other: headset; Other: standard drug

Interventions

mask OTHER

investigators will add eye mask to standard treatment

drug mask; drug mask headset

headset OTHER

investigators will add headset to standard treatment

drug headset; drug mask headset

standard drug OTHER

investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes

drug headset; drug mask; drug mask headset; standard drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

AnkaraCHBilkent

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 27580344 BACKGROUND

• 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.

  PMID: 23356519 BACKGROUND

• 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.

  PMID: 25304763 BACKGROUND

• Pamukcu Gunaydin G, Yildirim C, Sener A, Hassanien NTF. Earmuff and eye mask in the treatment of acute primary headache in emergency department: a randomized controlled open label study. BMC Emerg Med. 2025 Nov 28;25(1):249. doi: 10.1186/s12873-025-01405-7.

  PMID: 41315996 DERIVED

MeSH Terms

Conditions

Headache Disorders, Primary

Interventions

Masks

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Gül Pamukçu Günaydın, MD

  Ankara Yildirim Beyazit University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Faculty Member of Ankara Yildirim Beyazıt University, Principal Investigator

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: November 26, 2019
• Study Start: January 8, 2020
• Primary Completion: October 10, 2024
• Study Completion: November 2, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)