Effectiveness of Eye Mask and Noise Reduction Headset in Primary Headache

Primary Headache Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04178252
• Other study ID #: AYBU1
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Primary Headache Disorder

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