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Effectiveness of Eye Mask and Headset in Primary Headache

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04178252
Enrollment
140
Registered
2019-11-26
Start date
2020-01-08
Completion date
2024-11-02
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Headache Disorder

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.

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

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in pain30 minChange 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

MeasureTime frameDescription
need for rescue analgesic drug60 minPatients 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 treatment60 minPatients 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026