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Effectiveness of Eye Mask and Noise Reduction Headset in Primary Headache

Primary Purpose

Primary Headache Disorder

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mask
headset
standard drug
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Headache Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AnkaraCHBilkent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

standard drug

drug mask

drug headset

drug mask headset

Arm Description

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

Standard treatment plus eye mask

Standard treatment plus headset

Standard treatment plus headset plus eye mask

Outcomes

Primary Outcome Measures

change in pain
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
change in pain
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

need for rescue analgesic drug
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
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

Full Information

First Posted
October 8, 2019
Last Updated
October 10, 2022
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT04178252
Brief Title
Effectiveness of Eye Mask and Noise Reduction Headset in Primary Headache
Official Title
Effectiveness of Eye Mask and Noise Reduction Headset in Emergency Treatment of Primary Headache
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Headache Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard drug
Arm Type
Active Comparator
Arm Description
Standard treatment of primary headache with 10 mg metoclopramide IV in 150 ml saline given over 10 minutes
Arm Title
drug mask
Arm Type
Active Comparator
Arm Description
Standard treatment plus eye mask
Arm Title
drug headset
Arm Type
Active Comparator
Arm Description
Standard treatment plus headset
Arm Title
drug mask headset
Arm Type
Active Comparator
Arm Description
Standard treatment plus headset plus eye mask
Intervention Type
Other
Intervention Name(s)
mask
Intervention Description
investigators will add eye mask to standard treatment
Intervention Type
Other
Intervention Name(s)
headset
Intervention Description
investigators will add headset to standard treatment
Intervention Type
Other
Intervention Name(s)
standard drug
Intervention Description
investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes
Primary Outcome Measure Information:
Title
change in pain
Description
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
Time Frame
30 min
Title
change in pain
Description
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
Time Frame
60 min
Secondary Outcome Measure Information:
Title
need for rescue analgesic drug
Description
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
Time Frame
60 min
Title
preference of method over standard treatment
Description
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
Time Frame
60 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gül Pamukçu Günaydın, MD
Organizational Affiliation
Ankara Yildirim Beyazit University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
AnkaraCHBilkent
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27580344
Citation
Anagnostou E, Vikelis M, Tzavellas E, Ghika A, Kouzi I, Evdokimidis I, Kararizou E. Photophobia in primary headaches, in essential blepharospasm and in major depression. Int J Neurosci. 2017 Aug;127(8):673-679. doi: 10.1080/00207454.2016.1231185. Epub 2016 Sep 13.
Results Reference
result
PubMed Identifier
23356519
Citation
Wang J, Huang Q, Li N, Tan G, Chen L, Zhou J. Triggers of migraine and tension-type headache in China: a clinic-based survey. Eur J Neurol. 2013 Apr;20(4):689-96. doi: 10.1111/ene.12039. Epub 2013 Jan 28.
Results Reference
result
PubMed Identifier
25304763
Citation
Oktay C, Eken C, Goksu E, Dora B. Contribution of verbal suggestion to the therapeutic efficacy of an analgesic agent for acute primary headache. Cephalalgia. 2015 Jun;35(7):579-84. doi: 10.1177/0333102414553821. Epub 2014 Oct 10.
Results Reference
result

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Effectiveness of Eye Mask and Noise Reduction Headset in Primary Headache

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