Earmuff and eye mask in the treatment of acute primary headache in emergency department: a randomized controlled open label study.

backgroundPatients presenting to the ED with headache are placed in a quiet, darkened room to minimize external stimuli; however, creating and maintaining such an environment can be challenging in the context of a busy ED setting. This study evaluated whether adding noise-reduction earmuffs and sleep eye masks to standard metoclopramide therapy improves pain relief in adult patients presenting with acute primary headache in the emergency department.

methodsThis single-center, open-label, randomized, controlled, parallel-group trial was conducted in the urban emergency department of a tertiary care hospital. Adult patients diagnosed with primary headache were randomized (1:1:1:1) to receive: Standard treatment alone (10 mg metoclopramide in 150 mL normal saline over 10 min). Standard treatment plus earmuffs (3 M Peltor Optime III, SNR 35 dB). Standard treatment plus a disposable sleep eye mask (> 99.9% light blockage). Standard treatment plus both earmuffs and an eye mask. Pain intensity was recorded on a 100 mm visual analogue scale (VAS) at baseline (VAS0), 30 min (VAS30), and 60 min (VAS60). Primary outcomes were the differences ΔVAS30 and ΔVAS60 versus baseline. Before the study, we calculated that 34 patients in each group would be sufficient to detect a 13 mm difference between the ΔVAS scores between the groups that would be clinically significant.

resultsOf the 194 screened patients, 140 were randomized (n = 35 per group) and analyzed by intention to treat. At 30 min, the combination group exhibited a mean ΔVAS30 reduction 23 mm greater than standard treatment alone (P < .05), exceeding the 13 mm minimal clinically important difference. No significant intergroup differences were observed in ΔVAS60, patient preference, or rescue analgesia rates. No adverse events were reported.

conclusionsEarmuffs combined with sleep eye masks as an adjunct to metoclopramide significantly enhance early headache relief in the emergency department and represent a safe, low-cost complementary therapy. Participants were not blinded to the intervention due to practical constraints, and for the same reason, placebo control was not used.

trial registrationThe study protocol was established before starting and was registered at clinicaltrials.gov (Clinical Trials Identifier: NCT04178252, Date: 10.08.2019).