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Effectiveness of Eye Mask and Noise Reduction Headset in Primary Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178252
Recruitment Status : Unknown
Verified January 2020 by Gul Pamukcu Gunaydin, Ankara City Hospital Bilkent.
Recruitment status was:  Recruiting
First Posted : November 26, 2019
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Gul Pamukcu Gunaydin, 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.

Condition or disease Intervention/treatment Phase
Primary Headache Disorder Other: mask Other: headset Other: standard drug Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Eye Mask and Noise Reduction Headset in Emergency Treatment of Primary Headache
Actual Study Start Date : January 8, 2020
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Noise

Arm Intervention/treatment
Active Comparator: standard drug
Standard treatment of primary headache with 10 mg metoclopramide IV in 150 ml saline given over 10 minutes
Other: standard drug
investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes

Active Comparator: drug mask
Standard treatment plus eye mask
Other: mask
investigators will add eye mask to standard treatment

Other: standard drug
investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes

Active Comparator: drug headset
Standard treatment plus headset
Other: headset
investigators will add headset to standard treatment

Other: standard drug
investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes

Active Comparator: drug mask headset
Standard treatment plus headset plus eye mask
Other: mask
investigators will add eye mask to standard treatment

Other: headset
investigators will add headset to standard treatment

Other: standard drug
investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178252


Contacts
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Contact: Gül Pamukçu Günaydın, MD 905325643933 gulpamukcu@gmail.com
Contact: Çağdaş Yıldırım, MD 905057106614 drcagdasyil@gmail.com

Locations
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Turkey
AnkaraCHBilkent Recruiting
Ankara, Turkey
Contact: Gül Pamukçu Günaydın, MD    905325643933    gulpamukcu@gmail.com   
Sponsors and Collaborators
Ankara City Hospital Bilkent
Investigators
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Principal Investigator: Gül Pamukçu Günaydın, MD Ankara Yildirim Beyazit University Faculty of Medicine
Publications of Results:
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Responsible Party: Gul Pamukcu Gunaydin, MD, Faculty Member of Ankara Yildirim Beyazıt University, Principal Investigator, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier: NCT04178252    
Other Study ID Numbers: AYBU1
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache Disorders
Headache Disorders, Primary
Headache
Pain
Neurologic Manifestations
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases