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OpenTrials
Completed

NCT Number: NCT04178252

Effectiveness of Eye Mask and Headset in Primary Headache

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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Key information

Conditions

Primary Headache Disorder Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AnkaraCHBilkent

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mask

Other

investigators will add eye mask to standard treatment

headset

Other

investigators will add headset to standard treatment

standard drug

Other

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

Primary outcomes

  1. change in pain

    Time frame: 30 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

  2. change in pain

    Time frame: 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 outcomes

  1. need for rescue analgesic drug

    Time frame: 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

  2. preference of method over standard treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 26, 2019
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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