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CompletedNCT04178252Updated Jan 6, 2025

Effectiveness of Eye Mask and Headset in Primary Headache

An interventional study of mask and headset in Primary Headache Disorder, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Primary Headache Disorder
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In context

Headache Disorders, Primary

42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.

This study's enrollment of 140 is above the median of 50 across 19 interventional studies indexed under Headache Disorders, Primary.

Browse Headache Disorders, Primary studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • 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

  • Active comparator
    drug mask

    Standard treatment plus eye mask

    Other: mask · Other: standard drug

  • Active comparator
    drug headset

    Standard treatment plus headset

    Other: headset · Other: standard drug

  • Active comparator
    drug mask headset

    Standard treatment plus headset plus eye mask

    Other: mask · Other: headset · Other: standard drug

Interventions

  • Othermask

    investigators will add eye mask to standard treatment

  • Otherheadset

    investigators will add headset to standard treatment

  • Otherstandard drug

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 min

  2. 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

    Time frame: 60 min

Secondary outcomes

  1. 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

    Time frame: 60 min

  2. 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

    Time frame: 60 min

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Study locations

1 site
  • AnkaraCHBilkent
    Ankara, Turkey
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References and documents

Publications

  • 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. PubMed 27580344 ↗
  • 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. PubMed 23356519 ↗
  • 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. PubMed 25304763 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04178252
Responsible party
Gul Pamukcu Gunaydin (MD, Faculty Member of Ankara Yildirim Beyazıt University, Principal Investigator, Ankara City Hospital Bilkent) — Principal investigator
First posted
Nov 26, 2019
Start date
Jan 8, 2020
Primary completion
Oct 10, 2024
Completion
Nov 2, 2024
Last update
Jan 6, 2025

Study contacts

Gül Pamukçu Günaydın, MD
principal investigator · Ankara Yildirim Beyazit University Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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