Effectiveness of Eye Mask and Headset in Primary Headache

Not Applicable

Completed

• Conditions: Primary Headache Disorder
• Interventions: Other: mask; Other: standard drug; Other: headset

• Registration Number: NCT04178252
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Study Start: 2020-01-08
• Primary Completion: 2024-10-10
• Study Completion: 2024-11-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug mask headset	mask	Standard treatment plus headset plus eye mask
standard drug	standard drug	Standard treatment of primary headache with 10 mg metoclopramide IV in 150 ml saline given over 10 minutes
drug mask	mask	Standard treatment plus eye mask
drug mask	standard drug	Standard treatment plus eye mask
drug headset	standard drug	Standard treatment plus headset
drug mask headset	headset	Standard treatment plus headset plus eye mask
drug mask headset	standard drug	Standard treatment plus headset plus eye mask
drug headset	headset	Standard treatment plus headset

Primary Outcome Measures

Name	Time	Method
change in pain	60 min	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

Secondary Outcome Measures

Name	Time	Method
need for rescue analgesic drug	60 min	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
preference of method over standard treatment	60 min	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

Trial Locations

Locations (1)

AnkaraCHBilkent; 🇹🇷 Ankara, Turkey