Effectiveness of Eye Mask and Headset in Primary Headache

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-08

Study Completion Date

2024-11-02

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.

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Detailed Description

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Conditions

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Primary Headache Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Intervention Type OTHER

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

Interventions

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mask

investigators will add eye mask to standard treatment

Intervention Type OTHER

headset

investigators will add headset to standard treatment

Intervention Type OTHER

standard drug

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No