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

Abstract

Background

Patients 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.

Methods

This 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.

Results

Of 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.

Conclusions

Earmuffs 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 registration

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

Supplementary Information

The online version contains supplementary material available at 10.1186/s12873-025-01405-7.

Background

Acute headache is the 4th common chief complaint in the Emergency Department (ED) [1]. and makes approximately 4–16% of all ED visits [2, 3]. Headaches are categorized as either primary or secondary disorders based on the International Classification of Headache Disorders. Most of the patients presenting with headaches to ED have primary headache (migraine, tension type, cluster headache) whereas approximately 4–15% of them have secondary pathologies [3–5]. Acute primary headache is often diagnosed and treated as nonspecific headache in the ED [6].

Commonly in primary headache disorders light evokes or aggravates patients’ headache [7, 8]. Most individuals with migraines report that even low-intensity light increases pain during an attack, and similar symptoms have been noted in those with tension-type and cluster headaches [8, 9]. Noise stimuli have been identified as potential trigger for primary headache disorders. Consequently, management of acute headache episodes often includes rest in a quiet, dark environment to alleviate symptom severity [3]. In certain studies, patients 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 [10].

There is no consensus on the best treatment for primary headache in ED but according to current evidence antidopaminergic medications combined with Nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen is highly effective [11]. Metoclopramide is commonly used as an antidopaminergic agent and is considered to be one of the first line agents in ED treatment of headaches [1, 12]. Monotherapy is preferred for benign headaches [1]. NSAIDs alone are also effective and well tolerated in the treatment of migraine or tension type headaches [2]. Treatment can be preferred according to institutional protocols.

To the best of our knowledge, the combined use of noise-reduction earmuffs and eye masks as an adjunct to standard treatment for primary headache in the ED has not been previously investigated.

We hypothesized sleep eye masks and noise reduction headsets can help to add comfort of primary headache patients in an ED where they cannot always be provided with a dark quiet place to rest. The aim of this study was to determine the effectiveness of sleep eye masks and noise reduction earmuffs in reducing pain scores, and to determine if the method is preferred over standard treatment by patients when used in addition to standard treatment of primary headache syndromes in ED.

Methods

Study design

This is a prospective, single-center, open-label, randomized, controlled, superiority interventional study. Institutional ethics committee approved study protocol (Ankara Yildirim Beyazıt University Ethics Review Board decision number: 143) and the study was conducted in accordance with the Declaration of Helsinki. Study subjects provided written informed consent before participation. Participation was voluntary and subjects did not receive any benefits in return. The study protocol was established before starting and was registered at clinical trials.gov (Clinical Trials Identifier: NCT04178252, Date: 10.08.2019) Results were reported according to Consolidated Standards of Reporting Trials (CONSORT 2025) guidelines. Neither patients nor members of the public were involved in the design, conduct, or reporting of this study.

Study setting

The study was conducted at the ED, with approximately 1000 patients/ day, of a tertiary care hospital. Patients are triaged using the Turkish Ministry of Health’s 5 level triage scale that is very similar to the Australasian Triage Scale.

Participants

In triage, patients who reported multiple symptoms were specifically asked whether headache was their primary concern, in order to determine if headache should be recorded as the chief complaint [13].

Eligibility criteria:

1. Patients presenting to the ED with current headache and had triage category 3,4,5 were eligible for the study.

2. They were included if they had a preliminary clinical diagnosis of primary headache after brief history and physical exam by the attending physician according to the International Classification of Headache Disorders version 3 (ICHD-3) [14] and.

3. The attending physician decided the need and ordered intravenous (IV) treatment for the patient.

Patients were excluded if they met any of the criteria listed below.

Exclusion criteria:

1. Age < 18.

2. Pregnant.

3. Known or suspected diagnosis of a secondary etiology of headache at presentation or at any point during the patient’s ED visit (according to ICHD-3).

4. Head trauma within 14 days (falling and hitting the head on the floor, motor vehicle accident, hit on the head with a hard object).

5. Recurrent presentation with headache in the past 24 h.

6. Inability to comply with the study due to insufficient knowledge of Turkish Language,

7. Taking any analgesic drug in the last 4 h (NSAID, acetaminophen, ergo alkaloids or triptans) or taking maximum dose of the study drugs before coming to the ED.

8. History of GI bleeding in a year, known allergy or history of akathisia to standard treatment (metoclopramide), or rescue treatment (dexketoprofen).

9. Hepatic or renal failure in medical history.

10. Patients with documented hearing or vision loss.

11. Patients were only able to participate once in the study if they represented more than once during the study period.

Patients were excluded from the analysis if a secondary cause of headache was identified at any time during their ED visit.

Study protocol

Patients were recruited only on weekdays between 8:00–24:00 (80 h/week) because the faculty members who conducted the study and collected data were only available during these hours in the department. All faculty members, triage staff, nurses and physicians were informed about the study protocol and ICHD-3 before the start of the study. Between March 2020 and September 2022, the study was paused because of COVID19 pandemic. Data was not collected on individuals who declined to participate or who were otherwise missed by the investigators during the study period.

Randomization and blinding

Eligibility and enrollment of the patients was determined by the treating attending physician. Eligible patients were approached to undergo informed consent. After informed consent was obtained participants were assigned to 4 groups. Allocation sequence was generated by one of the researchers using a web based random number generator (www.random.org) with a 1:1:1:1 ratio. For allocation concealment randomization scheme was kept with the research secretary and each attending physician had to call and learn for the next allocation in the scheme once a patient was included in the study. Assessors of data collection forms and statistical analyzers were blinded to participants’ groups.

Blinding of participants was not possible due to the nature of the interventions (earmuff and eye mask), which were physically perceptible and could not be concealed.

Interventions

Participants in Group 1 received standard treatment for primary headache (10 mg metoclopramide in 150 ml normal saline infused over 10 min) Group 2 received standard treatment and noise reduction earmuff, Group 3 received standard treatment and sleep eye mask, Group 4 received both eye masks and noise reduction earmuffs in addition to standard treatment.

Noise reduction headset was 3 M’s Peltor Optime III H540A with an SNR number of 35 dB (H 40 dB, M 32dB, L 23dB). Eye masks were commercially available individually packaged, disposable, phototherapy eye protector bands which have a Conformité Européenne certificate and designed for adults with %99,9 light blockage. Noise reduction headset was disinfected with alcohol wipes between patients.

The intervention was delivered by trained emergency nurses, who put the earmuffs and the eye mask on the patient immediately after the standard treatment. Adherence was monitored, and participants were instructed to keep the devices on for at least 30 min. All participants in the intervention groups received the devices as intended, with no major deviations from protocol.

The intervention is non-invasive and low risk. However, potential adverse effects may include discomfort, anxiety, impaired communication, or skin irritation. Patients were monitored throughout the intervention and instructed that they could discontinue use of the earmuffs or eye mask at any time.

If a patient needed rescue analgesic, then the attending physician ordered 50 mg dexketoprofen IV.

Methods of measurement

Baseline data on demographics was recorded on the study data collection form. This data included the age, gender, past medical history, current medication, any history of headache diagnosis, vital signs, time of onset of pain, any medication taken for the headache in the previous 4 h and previous 24 h.

All patients marked their pain intensity on the form using 100 mm horizontal Visual Analogue Scale (VAS- in which 0 meant no pain and 100 the worst possible pain) for measuring pain intensity at time 0 (before IV treatment was started), and after 30 and 60 min. The need for rescue analgesic at 60 min and preference of the method was also recorded. At 30 and 60 min the patients were asked to complete VAS on a different sheet of paper to prevent comparison with the last score. Adverse events were also recorded in the study form. After completion of the forms all VAS scores were measured with the same ruler by the same person blinded to assigned groups.

Photophobia was assessed by asking if the light was disturbing and if the patient preferred to be in a darker room, and phonophobia was assessed by if the noise was disturbing and if patient preferred to be in a quieter room.

Outcome measures

Primary outcome was difference in pain intensity at 30 min (ΔVAS30) and 60 min (ΔVAS60) compared to pain measured by VAS at time 0. The patients were told they needed to stay preferably for 60 min for VAS measurement during enrollment but if a patient left the study before 60 min, then their VAS score was recorded at the time of discharge and these measurements were included in the analysis.

Secondary outcomes were patients’ preference of the method in the future, need for rescue analgesic drug as expressed by the patient at 60 min, and occurrence of adverse effects.

Statistical analysis

Data analysis was performed using SPSS statistical software, version 20.0 for Windows (SPSS Inc., Chicago, IL, USA) All enrolled patients were analyzed even if they withdrew from the study before completion. Analyses were conducted with an intention-to-treat approach.

Normality was assessed using the Shapiro-Wilk test and visual inspection of the histograms. Continuous variables were reported as mean ± standard deviation for normally distributed data or median with interquartile range for non-normally distributed data. Comparison of continuous variables without normal distribution between four groups was performed by Kruskal-Wallis test. Box-plot graphs were used with median (25–75%) for the expressions. Comparison of rates for categorical variables was performed by Pearson Chi-squared test. Bonferroni correction was used for post hoc subgroup analysis. All hypotheses were two tailed and the P value 0.05 was considered to be significant.

No interim analyses were planned, and no formal stopping guidelines were established, as the intervention was considered low-risk and unlikely to result in significant harm or unexpected outcomes.

Sample size calculations

Sample size was determined using the calculators at https://www.stat.ubc.ca/. 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. This threshold was selected based on findings by Todd et al., who reported that the minimal clinically significant difference in pain scores measured by a 100 mm VAS is 13 mm (95% CI: 10 to 17 mm) [15]. Sample size calculations were performed using alfa = 0.05, beta = 0.20 and the two tails.

Results

Participant flow

During the study period a total number of 194 patients presented to the ED with a chief complaint of headache. According to exclusion criteria 54 patients were excluded. 140 patients consented to participate and were enrolled in the study. 35 patients were allocated to each group, and 140 patients’ data were included in the final analysis. An intention to treat analysis included all enrolled patients by carrying the last available VAS score forward to the missing scores if there is any missing measurement for 30- or 60-min VAS scores. There were no missing scores on 30 min. One patient in group 1, 2 patients in group 2, and 3 patients in group 4 were lost to follow up for 60 min, no patient was lost to follow up in 60 min in group 3. These are shown in the flowchart (Fig. 1).

Fig. 1.

Flowchart of the study

Characteristics of the study subjects

The mean age of participants was 39.38 (SD, 13.73) years and 62.1% (n = 87) of them were female. There were no significant differences between the groups with respect to age or gender distribution. Baseline patient characteristics of groups in terms of comorbidities, primary headache history, pain duration, photophobia, darkness choice (prefers to be in a darker room), phonophobia and silence choice (prefers to be in a quite room) are shown in Table 1. Baseline median VAS0 score of all patients was 75 mm (61.3–85). Use of additional diagnostic tools such as CT, MR and blood analysis was not different between groups (P = .478). No secondary cause of headache was detected in patients after these diagnostic studies.

Table 1.

Baseline characteristics of participants

		Interventions
		Standard (Group 1)		Standard + earmuff (Group 2)		Standard + eye mask (Group 3)		Standard + earmuff + eye mask (Group 4)		P-value**
Variables		n (%)	Med (25–75%)	n (%)	Med (25–75%)	n (%)	Med (25–75%)	n (%)	Med (25–75%)
Gender	Female	19 (54.3)		19 (54.3)		24 (68.6)		25 (71.4)		0.292
	Male	16 (45.7)		16 (45.7)		11 (31.4)		10 (28.6)
Age (year)			42 (36–50)		33 (23–50)		37 (27–52)		37 (30–47)	0.155
Hypertension		2 (5.7)		0 (0)		4 (11.4)		0 (0)		-
Diabetes mellitus		2 (5.7)		0 (0)		0 (0)		2 (5.7)		-
Asthma		0 (0)		2 (5.7)		0 (0)		0 (0)		-
Urticaria		0 (0)		2 (5.7)		0 (0)		0 (0)		-
History of primary headache		13 (37.1)		11 (31.4)		8 (22.9)		19 (54.3)		0.046*
Pain duration (hour)			6 (3–18)		9 (4–16)		13 (4–24)		11 (5–24)	0.229
Photophobia		15 (42.9)		18 (51.4)		14 (40)		30 (85.7)		<0.001‡
Darkness choice		15 (42.9)		26 (74.3)		23 (65.7)		29 (82.9)		0.003§
Phonophobia		13 (37.1)		18 (51.4)		10 (28.6)		28 (80)		< 0.001†
Silence choice		18 (51.4)		28 (80)		22 (62.9)		34 (97.1)		< 0.001¶

*The difference originated from the difference between groups 3 and 4

‡The difference originated from group 4

§The difference originated from the difference between pairs 1–2 and 1–4

†The difference originated from group 4

¶The difference originated from the difference between pairs 1–4 and 3–4

**Pearson chi-squared test; Kruskal Wallis test (Bonferroni correction was used for subgroup analyses)

Med: Median

Primary and secondary outcomes

VAS 0, VAS 30, VAS 60, ΔVAS30, ΔVAS60 and need for rescue analgesia of the groups was shown in Table 2. Baseline VAS score of Group 4 (standard treatment + earmuff + eye mask) group was significantly higher than group 2 (standard treatment + earmuff) group.

Table 2.

Primary and secondary outcome comparisons between groups

		Interventions
		Standard (Group 1)		Standard + earmuff (Group 2)		Standard + eye mask (Group 3)		Standard + earmuff + eye mask (Group 4)		P-value*
Variables		Med (25–75%)	n (%)	Med (25–75%)	n (%)	Med (25–75%)	n (%)	Med (25–75%)	n (%)
VAS-0		80 (55–89)		69 (62–75)		72 (51–85)		78 (73–95)		0.006†
VAS-30		43 (24–60)		38 (21–46)		43 (22–47)		28 (19–52)		.407
VAS-60		26 (12-38.4)		17.7 (2.4–32)		17.2 (3-28.6)		13.4 (0-40.2)		0.251
ΔVAS30		25 (20–34)		27 (17–54)		32 (29–43)		48 (30–59)		0.008‡
ΔVAS60		44 (35–57)		42 (27–63)		50 (40.8–61)		57.8 (47.7–71)		0.073
Prefers the same method in the future	No/ uncertain		13 (37.1)		14 (40.0)		13 (37.1)		10 (28.6)	0.772
	Yes		22 (62.9)		21 (60)		22 (62.9)		25 (71.4)
Need for rescue analgesia			11 (31.4)		4 (11.4)		5 (14.3)		8 (22.9)	0.147

*Kruskal Wallis test; Pearson Chi-squared test (Bonferroni correction was used for subgroup analyses)

†The difference originated from the difference between groups 2 and 4

‡ The difference originated from the difference between groups 1 and 4

SD: Standard deviation; Med: Median; VAS: Visual analog scale; Diff: Difference

ΔVAS30: VAS30-VAS0

ΔVAS60: VAS60-VAS0

Our primary outcome measures were ΔVAS30 and ΔVAS60. There was a statistically significant difference between ΔVAS30 of group 1 (standard treatment) and group 4 (standard + earmuff + eye mask) (Table 2). This difference (23 mm) is clinically significant as well.

No adverse events or harms were recorded in any arms of the study. We did not find any significant difference between groups in terms of patients’ preference for the same method in the future and need for rescue analgesia (Table 2).

Discussion

This randomized, controlled study of ED patients with primary headache treated with 10 mg metoclopramide compared outcomes between patients that eye masks and noise reduction earmuffs in addition to metoclopramide treatment. We observed statistically and clinically significant difference between ΔVAS30 of group 1 (standard treatment) and group 4 (standard + earmuff + eye mask).

To provide rapid, complete and sustained pain relief with minimal side effects is very important for the patients with primary headache but this ultimate goal is not commonly reached in ED [2, 11, 16]. Primary headache treatment is an area that would benefit from improvement [17]. The ideal headache treatment in ED should provide rapid relief and allow patients to leave the department in a short time with satisfaction and no need to return in a short time.

We decided to include all primary headaches in our study and did not make specific primary headache diagnosis because of the following reasons. Vast majority of primary headaches in the ED are migraine and tension type headache, and most headache patients don’t get a specific diagnosis. Once you rule out secondary causes you can treat undifferentiated headaches in the ED [1, 6, 18]. Specific differentiation of primary headache subtypes did not change treatment and thus is not important in ED as suggested in previous studies. The presenting VAS and pain relief was similar for all primary headaches [17]. While a comprehensive interview in the ED can facilitate reproducible classification of headache patients, approximately one-third of individuals presenting with acute headache may not receive a specific diagnosis during their ED visit. Furthermore, ED-based headache research often includes diagnostic categories such as benign headache or uncomplicated headache, which are not recognized within ICDH depending on a patient’s history of similar headache episodes or the identification of a demonstrable secondary cause. If these are absent ICDH cannot provide a diagnosis [13].

Light and noise are amongst the common triggers for migraine and tension type headache. Avoidance of precipitants can decrease the frequency of headaches [19]. Although photophobia and phonophobia are almost universal experience in primary headache syndromes in ED, little attention has been given to managing these symptoms in the ED. According to a review, the most frequently reported intervention during a migraine attack is retreating to a dark environment [20]. Noise measurements indicate that the ED is among the loudest environments within a hospital setting. Although the World Health Organization recommends that hospital noise levels should not exceed 35 dBA, studies have reported average noise levels in the ED surpassing 55 dBA, with peak levels reaching nearly 117 dBA [21]. That is why we aimed to measure the effect of reducing light and noise stimuli for additional comfort for patients with primary headache in ED.

The mean initial pain score for headache in our study was 75 mm and that was similar to the literature [2, 22]. Headaches affect women more commonly [11, 22]. Women consisted of 62.1% percent in our study and our finding is compatible with the literature. According to a study conducted in China the frequencies of light and noise as triggers were greater in females in migraine and tension type headache [19].

Antidopaminergic drugs are given in primary headache not only for analgesia but also for antiemetic effects [11]. Metoclopramide is commonly used in doses of 10 mg IV [23]. Since potential side effects like dystonia and akathisia can occur related to infusion rate [11, 24], we chose IV infusion over 10 min.

Small differences in VAS pain scores may be statistically significant but clinically unimportant. In their study that was conducted in ED, Todd et al. found that minimum clinically significant change in pain scores measured by 100 mm VAS is 13 mm (%95 CI, 10 to 17 mm) [15]. In our study, there was statistically significant difference between ΔVAS30 of group 1 (standard treatment) and group 4 (standard + earmuff + eye mask) (Table 2). This difference (23 mm) was considered clinically significant.

Although our findings demonstrate a clinically significant 23 mm reduction in VAS scores, it is important to consider that the improvement may not be solely attributable to the sensory-modifying effects of the noise-reducing headset and eye mask. Simply receiving an intervention in the ED—such as the provision of comfort-enhancing equipment—may elicit placebo or reassurance-related responses that influence patients’ pain perception. These contextual effects can contribute to symptom relief independent of the specific mechanisms of the devices. Future studies incorporating a sham or alternative control condition could help further differentiate the specific impact of sensory reduction from these broader comfort-related influences.

Friedman et al. proposed that the measure of ‘would take again’—reflecting whether patients would choose to receive the same treatment during a subsequent ED visit for migraine—is associated with migraine outcomes and should be incorporated as a secondary outcome measure in ED migraine trials [25]. We have found no difference between groups in terms of preference of the method in the future between groups.

Limitations

We did not follow patients after 1 h for pain score or recurrent pain or sustained pain relief because it is hard to monitor patients for more than 1 h in our busy department and we did not think the effects of headset or eye mask to last after ED treatment window. We did not measure the rate of return visits, headache recurrence or late adverse effects. Participants were not blinded to the intervention due to practical constraints, and for the same reason, placebo control was not used. This lack of participant blinding may have introduced potential sources of bias including performance, measurement or reporting bias, particularly given the reliance in self-reported pain scores, potentially leading to an overestimation of the treatment effect. This is especially important because the primary end point is self reported pain scores. We aimed to recruit all patients during the study hours, but it is possible that patients arriving at busy hours might be missed. We can only generalize the results to ED setting where it is hard to find a dark and quiet place.

A statistically significant difference in baseline VAS0 scores was observed between the groups, particularly between Group 2 and Group 4 (P = .006), suggesting that randomization may not have achieved complete group equivalence. The presence of higher baseline pain levels in one group could have potentially led to an overestimation of the intervention’s effectiveness, since patients with higher initial pain might showed greater relative improvement.

Conclusions

In our study, there was a statistically and clinically significant difference between ΔVAS30 of group 1 (standard treatment) and group 4 (standard + earmuff + eye mask). Our results support the use of eye masks and noise reduction earmuffs in the treatment of primary headache in ED in addition to medical treatment.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

ED

Emergency Department

NSAIDs

Nonsteroidal anti-inflammatory drugs

SNR

Signal-to-Noise Ratio

ICHD-3

International Classification of Headache Disorders version 3

VAS

Visual Analogue Scale

IV

Intravenous

Δ

Delta

Author contributions

Conceptualization: [GPG], [ÇY], [AŞ]; Methodology: [GPG], [ÇY], [AŞ]; Data acquisition: [GPG], [ÇY], [NTFH]; Formal analysis and investigation: [GPG], [ÇY], [AŞ], [NTFH]; Writing - original draft preparation: [GPG], [ÇY], [AŞ]; Writing - review and editing: [GPG], [ÇY], [AŞ], [NTFH]; Statistical Expertise: [GPG], [AŞ]; Supervision: [ÇY], [AŞ]

Funding

None.

Data availability

The datasets generated and/or analysed during the current study are available in the Elsevier’s Mendeley Data repository, https://doi.org/10.17632/xfxdkr75js.1.

Declarations

Ethics approval and consent to participate

Institutional ethics committee approved study protocol, and the study was conducted in accordance with the Declaration of Helsinki (Ankara Yildirim Beyazıt University ethical review board decision number: 143). Study subjects provided written informed consent before participation.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.