Effectiveness of Eye Mask and Headset in Primary Headache

Ankara City Hospital

Status: Completed

Conditions: Primary Headache Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04178252

AYBU1

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 4 patient groups

standard drug

Active Comparator group

Description:

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

Treatment:

Other: standard drug

drug mask

Active Comparator group

Description:

Standard treatment plus eye mask

Treatment:

Other: standard drug

Other: mask

drug headset

Active Comparator group

Description:

Standard treatment plus headset

Treatment:

Other: standard drug

Other: headset

drug mask headset

Active Comparator group

Description:

Standard treatment plus headset plus eye mask

Treatment:

Other: standard drug

Other: headset

Other: mask