J Sleep Res.

(2017) Review Paper

Effect of the use of earplugs and eye mask on the quality of

sleep in intensive care patients: a systematic review
HANA LOCIHOVA  AK

1 , 2 , 3 , K A R E L A X M A N N 4 , 5 , H A N A P A D Y S
OVA

3 and
6
JAKUB FEJFAR
1
Department of Nursing, Jesseniuss Faculty of Medicine in Martin, Comenius University in Bratislava, Slovak Republic; 2AGEL Educational and
 jov, Czech Republic; 3Faculty of Nursing and Professional Health Studies, Slovak Medical University
Research Institute (VAVIA), Proste
4
Bratislava, Slovak Republic; Department of Anesthesiology, Resuscitation and Intensive Care Medicine, University Hospital Olomouc, Czech
Republic; 5Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic; 6Department of Urology, Hospital Nov
y Jic
ın,
Czech Republic

Keywords
earplugs, eye mask, quality of sleep,
hospitalisation, intensive care unit
Correspondence
Hana Locihova
MSN, RN, AGEL Research and
Training Institute (VAVIA), Mathonova 291/1,
Prostejov, 79604, Czech Republic.
Tel.: +420-739-026-151;
fax: +420-582-315-952;
e-mail: h.reichelova@seznam.cz
Accepted in revised form 26 July 2017; received
9 May 2017revised July 9, 2017
DOI: 10.1111/jsr.12607
SUMMARY
Intensive care unit (ICU) environment has a very strong and unavoidable
negative impact on patients’ sleep. Sleep deprivation in ICU patients has
been already studied and negative effects on their outcome (prolonged
ICU stay, decreased recovery) and complication rates (incidence of
delirium, neuropsychological sequels of critical illness) discussed.
Several interventions potentially improving the sleep disturbance in
ICU (sleep-promotion strategies) have been assumed and tested for
clinical practice. We present a review of recent literature focused on
chosen types of non-pharmacological interventions (earplugs and eye
mask) analysing their effect on sleep quality/quantity. From the total
amount of 82 papers found in biomedical databases (CINAHL, PubMed
and SCOPUS) we included the 19 most eligible studies meeting defined
inclusion/exclusion criteria involving 1 379 participants. Both experi-
mental and clinical trials, either ICU and non-ICU patient populations
were analysed in the review. Most of the reviewed studies showed a
significant improvement of subjective sleep quality when using described
non-pharmacological interventions (objective parameters were not
significantly validated). Measuring the sleep quality is a major concern
limiting the objective comparison of the studies’ results since non-
standardised (and mainly individual) tools for sleep quality assessment
were used. Despite the heterogeneity of analysed studies and some
common methodological issues (sample size, design, outcome para-
meters choice and comparison) earplugs and eye mask showed potential
positive effects on sleep quality and the incidence of delirium in ICU
patients.

wound healing (Mostaghimi et al., 2005), to the reduction of

INTRODUCTION
Sleep is one of the basic physiological needs. In the last
decade, an unprecedented number of studies have been
carried out focusing on sleep deprivation in intensive care
unit (ICU) patients. There is increasing evidence that
connects sleep deprivation associated with general alter-
ations in a patient’s condition with negative biological impacts
on the organism (Friese, 2008). Epidemiological data indicate
that sleep deprivation has a mutually conditional relationship,
e.g. pain leads to insomnia and sleep deficiency decreases
the pain threshold and contributes to the extended periods of
growth hormone (Ruiz et al., 2007) and to affecting meta-
bolic, endocrine and immunological responses (Spiegel
et al., 1999). Studies confirm an increased incidence of
hypertension, heart rate (Arora et al., 2011), the presence of
delirium and confusion (Figueroa-Ramos et al., 2009; Patel
et al., 2014), a decreased performance in daily activities and
reduced quality of life, as determined by a questionnaire
completed by patients (Martin et al., 2010).
The studied and documented negative impacts above
relate to both the normal population (those from the quota-
tions above that relate to non-ICU population) and specifically

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et al.
H. Locihova
to ICU patients, where primarily the influence of sleep
deprivation on the incidence of delirium is discussed
(Figueroa-Ramos et al., 2009) and the neuropsychological
consequences of survivors (ICU survivors) within the so-
called post-intensive care syndrome (e.g. a cognitive deficit,
anxiety, post-traumatic stress disorder) (Desai et al., 2011).
Two basic groups of techniques for evaluating sleep quality
(objective and subjective) are distinguished. Objective tech-
niques include polysomnography (PSG), actigraphy (ACT)
and a method of measuring brain activity using the bispectral
index (BIS). The greatest advantage of objective methods is
the evaluation of both the quantity and quality of sleep
(detailed assessment of sleep architecture) (Pisani et al.,
2015). Sporadic studies were carried out in ICUs abroad (on
a small sample of patients) using PSG (limitations include
technical, cost-related and time requirements). However,
their outputs provide valuable information concerning sleep
disorders. They confirm the existence of changes not only in
terms of quantity, but also of quality. The sleep of ICU
patients with altered consciousness (a disorder of conscious-
ness, sedation) is fragmented and its architecture is disrupted
(Cooper et al., 2000; Freedman et al., 2001).
In order to determine sleep quality, nurses use subjective
techniques as a simple tool that allows the assessment. At
present, there is a variety of self-assessment scales and
questionnaires focused upon quantifying and qualifying sleep
quality and sleep disorders as well as on factors which have a
significant negative effect on ICU patients’ sleep.
The Richards Campbell Sleep Questionnaire (RCSQ) is
the most commonly used tool for evaluating subjective quality
of sleep in ICUs. The questionnaire was created originally for
such patients and was validated scientifically (Richards et al.,
2000). Validity, reliability and intrinsic consistency have been
confirmed in previous studies (Frisk and Nordstro €m, 2003;


Kamdar et al., 2012; Nicolas et al., 2008). The RCSQ
contains five items (sleep depth, number of awakenings,
percentage of time awake and overall quality of sleep). Each
item is rated using a 0–100 visual analogue scale (VAS). The
total score is derived from the sum of the individual items
divided by their number: 0 represents the worst sleep, 100
the best sleep. The RCSQ provides a short, applicable,
comprehensive and simple tool to assess sleep quality in the
ICU and is the most widespread. Another tool for sleep
quality assessment that can be used in an ICU is the Verran
and Snydern Halpern Sleep Scale (VSH), which was created
in 1987 for hospitalized patients. Different versions are
available that include eight to 16 items. The use of subjective
assessment tools at the ICU is often very difficult to
implement due to the overall condition of a patient with a
present or imminent failure of vital functions (including
consciousness) (Hoey et al., 2014; Ritmala-Castren et al.,
2013) and the mismatch between the assessors, i.e. patient–
nurse (Kamdar et al., 2012).
Factors contributing to sleep disorders in ICUs can be
divided into two categories (environmental and non-
environmental), between which there is a significant causal
relationship. Non-environmental factors include the under-
lying disease and the current medical condition of the
patient, pain and discomfort, psychosocial factors (stress,
anxiety) and medication. Environmental factors include
noise, light and nursing interventions (Tembo and Parker,
2009).
The most cited element causing sleep disorders of ICU
patients is noise (Bihari et al., 2012; Li et al., 2011), which
is inconsistent with the results of two studies (Freedman
et al., 2001; Gabor et al., 2003) indicating that environ-
mental factors (noise and nursing interventions) are over-
estimated in relation to sleep disorders. The Environmental
Protection Agency (EPA) has issued a recommendation
that the noise level in health-care facilities should not
exceed 45 decibels (dB) by day and 35 dB at night.
Previous studies have shown that the level of noise in
intensive care is exceeded consistently within the range of
60–80 dB.
Some major sources of noise include equipment alarms,
loud personnel conversations, screams of other patients,
telephones and television, etc. In order to achieve and
maintain quality sleep, it is necessary to implement organi-
zational measures reducing noise. The principles of so-called
sleep promotion strategy are non-pharmacological nursing
interventions. Four major domains of the described strategy
can be identified: reduction of noise, reduction of light,
clustering nursing activities and increasing the patient’s
comfort (Eliassen and Hopstock, 2011; Ug €
rasß and Oztekin,
2007). The introduction of non-pharmacological interventions
supporting sleep with the emphasis on using earplugs and
eye masks is perceived as an inexpensive tool to improve
sleep quality of hospitalized patients. While the measures
described are gradually becoming a common part of every-
day nursing practice globally, this simple and inexpensive
tool in potentially improving the quality of care has not yet
been implemented widely in the Czech Republic. The aim of
the current work is to comment on the effectiveness of
selected non-pharmacological interventions and to provide a
basis for discussion of whether these measures may have an
impact upon the improvement of the short-term (reduction of
delirium, shortening of hospitalization time) and long-term
outcomes (reduction of neuropsychological consequences
within the post-ICU syndrome).
METHODS
The aim of this study was to use available recent and relevant
literature sources to confirm whether selected non-pharma-
cological interventions (earplugs, eye masks) have a positive
effect on the quality of sleep in ICU patients.
To confirm the tested hypothesis (‘the described non/
pharmacological interventions have a positive effect on the
quality of sleep in ICU patients’), results of an analysis of
available original scientific papers were used. Inclusion/
exclusion criteria and search strategies were defined. Papers
meeting the criteria for inclusion were analysed further.
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These methods were consistent with general principles of
evidence-based medicine (Ryan, 2016).
Inclusion and exclusion criteria
Based on the above research question, the following inclu-
sion criteria were defined: a time-frame of 1990–2015 (older
studies were considered outdated), the full text of the paper
available in English and original papers in peer-reviewed
journals; the exclusion criteria were: only abstracts available,
papers published outside the above time-frame and reviews.
Sources
The following literary databases were used: CINAHL,
PubMed and SCOPUS.
Search strategy
For the search strategy, the following constructs were used
when formulating a query in a patient–intervention–com-
parison–outcome (PICO) format. In the initial phase of the
search, the primary keywords were extended by synonyms
and analogical terms connected by Boolean operators,
AND and OR (critically ill OR intensive care OR critical
care) AND (eye mask OR earplugs) AND (eye protective
device OR ear protective device) AND (routine care OR
standard care) AND (quality of sleep OR improve sleep OR
sleep promoting).
The same search criteria were used for each database. A
quantitative content analysis was conducted to analyse the
papers.
RESULTS AND ANALYSIS
A total of 82 studies were found in selected databases.
Based on the primary analysis, studies not relevant for the
specified area of interest and studies which did not meet the
selection criteria (or met the exclusion criteria) were
excluded. A total of 19 works was included in the analysis
and in the review—three studies were conducted in simulated
ICU conditions and 16 studies in real ICU conditions. The
process of study selection is presented as a PRISMA
(Preferred Reporting Items for Systematic Reviews and
Meta-Analyses) flow diagram (Fig. 1). The analysed studies,
methods and results are summarized in Table 1.

Records identified through Additional records identified

database searching (n = 82) through other sources (n = 0)

Records after duplicates removed

(n = 38)

Records screened Records excluded (n = 17)

(n = 38)

Full-text articles excluded

Full-text articles assessed for with reason (n = 2)
eligibility (n = 21)

Studies included in qualitative

synthesis (n = 0)

Studies included in
quantitative synthesis
(n = 19)

Figure 1. The process of study selection (a PRISMA flow diagram).

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H. Locihova

Table 1 Characteristics of studies on the effect of the use of earplugs and eye masks in hospitalized patients and their impact on the
quality of sleep in intensive care units

Author, year,
country Intervention Study design Evaluation method Evaluated parameter

Wallace et al. (1999), Earplugs Randomized cross-over experimental PSG REM latency (min);
USA trial, sleep laboratory (ICU proportion of REM
environment simulation), healthy phase (%)
volunteers (n total = 7)
Hu et al. (2010) China Earplugs, eye mask Randomized cross-over experimental PSG, hormonal levels, REM latency (min),
trial, sleep laboratory (ICU subjective self-assessment of REM phase proportion (%),
environment simulation), healthy sleep quality by the original melatonin metabolite
volunteers (n total = 14) method (SAI) (6-SMT) (lg/L) cortisol
(lg/L) level, SAI score

Huang et al. (2015) Earplugs, eye mask, Randomized cross-over experimental PSG, hormonal levels, Sleep onset latency (min),
China exogenous melatonin trial, sleep laboratory (ICU subjective self-assessment of number of awakenings (n),
substitution 1 mg environment simulation), healthy anxiety and sleep quality by sleep arousal index,
after volunteers divided into 4 groups (n the original method (SAI) melatonin level
total = 40) (hourly profile), SAI score,
anxiety (score)

Daneshmandi et al. Eye mask Controlled clinical trial, coronary ICU, Subjective assessment: PSQI PSQI score
(2012) Iran (n total = 60), 30 control and 30 case questionnaire*
group)
Babaii et al. (2015), Eye mask Randomized controlled study, coronary Subjective assessment: PSQI PSQI score
Iran ICU (n total = 60), 30 control and 30 questionnaire*
interventional)
Haddock (1994), Great Earplugs Randomized controlled study, Subjective assessment: Sleep quantity (score);
Britain gynaecological ICU (n total = 18), 9 original questionnaire sleep quality (score)
control and 9 interventional)
Scotto et al. (2009), Earplugs Quasi-experiment design with Subjective assessment: VSH Sleep quantity (score);
USA randomization, multi-disciplinary ICU sleep quality (score)
(n total = 88), 39 control and 49
interventional)

Neyse et al. (2011), Earplugs Controlled clinical trial, coronary ICU, Subjective assessment: PSQI* PSQI score
Iran (n total = 60), 30 control group and 30
case group

Van Rompaey et al. Earplugs Randomized controlled study, Subjective assessment: sleep: Sleep quantity (score);
(2012), Belgium University Hospital ICU (n original questionnaire (5 sleep quality (score)
total = 136) 67 control and 69 items), delirium: NEECHAM
intervention groups scale

Ryu et al. (2011), Earplugs +eye mask  Experiment design with randomization, Subjective assessment: VSH Sleep quantity (score);
China relaxing music coronary ICU (n total = 58) 29 control sleep quality (score)
(plugs and mask) and 29
experimental group (music and mask)

Hu et al. (2015a,b), Earplugs + eye mask Randomized controlled study, cardiac Objective assessment: Levels of 6-SMT and
China  relaxing music surgery ICU (n total = 45) 25 control hormonal levels cortisol in urine;
(routine care) and 20 interventional Subjective assessment: RCSQ RCSQ score

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Results: interventions confer
(cf.) controls
REM latency (mean): 106.7 (SD:
53.0) cf. 147.8 (53.0); P = 0.02
REM phase (mean: 19.9 (SD: 4.5)
14.9 (5.4); P = 0.04
REM latency (mean): 105.7 (SD:
47.0) cf. 146.9 (SD 56.0),
P = 0.013
REM phase proportion: 9.3 (SD:
4.3) cf. 12.9 (SD 4.3); P = 0.005
Sleep arousal index (mean): 12.2
(SD: 6.5) cf. 15.1 (SD: 6.2) versus
P = 0.04
6-SMT level (mean): 22.3 (0.9) cf.
15.1 (1.5); P = 0.002
SAI score (mean): 4.1 (1.7) cf. 2.3
(1.3); P = 0.001
Sleep onset latency (mean): 46.6
(SD: 21.6) cf.71.4 (SD: 25.6);
P = 0.01
Number of awakenings: 10.5 (3.2)
cf. 15.1 (3.3); P = 0.001
Sleep arousals index: 5.5 (2.1) cf.
9.8 (3.0); P = 0.000
Melatonin: higher mean levels in all
profile hours P < 0.05
SAI score (mean): 6.1 (1.0) cf. 3.4
(0.8); P = 0.000
Anxiety (mean): 33.5 (5.0) cf. 46.0
(8.8); P = 0.000
PSQI score (mean): 10.46 (SD:
4.09) cf. 7.4 (SD: 2.2); P = 0.001
PSQI score (mean): intervention 3
(SD: 3) cf. 10 (SD: 5); P = 0.001
Sleep quality (mean difference):
17.3 (P < 0.01); sleep quantity
(mean difference) 5.9 (P < 0.01)
The total sleep score was
significantly better in the
intervention group (t = 3.253,
P = 0.002). In 7 of 8 domains, a
statistically significant
improvement was confirmed
(P = 0.005–0.044)
PSQI total score of sleep quality
(mean): intervention: 6.3 (SD: 2.1)
cf. 8.4 (1.9); P < 0.001
Subjective sleep quality: significant
improvements in the intervention
group only the first night
(P = 0.042) (2–4 no significance)
Sleep quantity: experiment 279.31
(SD: 43.99) cf. controls 243.10
(42.68); P = 0.002
Sleep quality: 36.14 (5.68) cf.
29.41 (3.85); P < 0.001
A statistically significant
improvement in the subjective
quality of sleep in all 5
questionnaire items in the
intervention group (P < 0.05)
Levels of the observed hormones
without a statistically significant
ª 2017 European Sleep Research Society
Effect of the use of earplugs and eye mask in ICU
The effect size (Cohen’s d) for
the selected parameter
REM latency: 7.754717
REM phase: 1.005953
REM latency: 7.969634.
REM phase: 0.837209
sleep arousal index: 0.456566
6-SMT level: 5.820855
SAI: 1.189473
Sleep onset latency: 1.047094
Number of awakenings: sleep
arousals index: 1.660615
SAI score 4.736113
anxiety: 1.684697
57.830512
1.697749
NA (absolute values not available)
NA (absolute values not available)
1.04869
NA (specific sleep quality data not
specified)
Sleep quantity: 1.19262
Sleep quality: 9.775195
NA
Other effects
Comfort: involved participants
rated the method as comfortable
Comfort: earplugs rated as
uncomfortable, eye mask as
comfortable
NA
Comfort: the intervention was rated
as comfortable
Comfort: the intervention was rated
by many participants as
uncomfortable
Medication: confirmed statistically
significant drop in sleep
medication
Proven reduced confusion and
delirium: in the intervention group:
hazard ratio (HR): 0.47 (95%
confidence interval CI: 0.27–
0.87).
Noise: the noise level in the groups
was not statistically significant
(69.8  2 dB/69.6  2.2 dB,
P = 0.6)
5
Conclusion
Earplugs reduce negative effects of
noise, proven positive impact of
earplugs on selected PSG
parameters
In experimental conditions, proved
positive effects of interventions on
sleep architecture (PSG, 6-SMT)
and perceived quality subjectively
The combination of interventions
(eye mask, earplugs, melatonin)
statistically influences most
significantly subjectively and
objectively measured sleep
quality
Using an eye mask improves the
subjective sleep quality
significantly
The eye mask affects the
subjective quality of sleep in
selected domains
Earplugs have a positive impact on
reducing perceived noise and
improve subjective sleep quality
Earplugs have a positive effect on
selected patient groups
The use of earplugs improves the
quality of sleep measured by
PSQI and reduces the use of
medication
The use of plugs is a useful tool to
reduce the prevalence of early
delirium and confusion. The effect
of intervention on sleep quality is
confirmed only for the first night
Music has a better impact on the
quality of sleep than the isolated
use of plugs
Using interventions is a good tool
to improve sleep quality
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H. Locihova

Table 1 Continued

Author, year,
country Intervention Study design Evaluation method Evaluated parameter

Kamdar et al. (2013), Earplugs + eye mask Observational trial, pre–post design, Subjective assessment: RCSQ RCQS score
USA  relaxing music ICU University Hospital (n (incidence of delirium) (delirium: CAM-ICU)
total = 300), pre: 122 (634 patient
day), post 178 (826 patient day)

Richardson et al. Earplugs + eye mask Post-test quasi-experiment design (no Subjective assessment: Sleep quantity (score);
(2007), UK randomization), cardiac surgery ICU original questionnaire sleep quality (score)
(n total = 62 people), 34 non-
interventional, 28 interventional

Jones and Dawson Earplugs + eye mask Pre–post quasi-experimental design, Subjective assessment: Sleep quantity (score);
(2012), UK no randomization, surgical ICU (n original questionnaire sleep quality (score)
total = 100), pre-50, post-50

Le Guen et al. (2014), Earplugs + eye mask Randomized controlled study, ICU Actigraphy (ACT) subjective ACT (duration and intensity
France post-anaesthetic care (PACU) (n assessment: SS (Spiegel of accelerometer-sensed
total = 41), 21 control and 20 score) and MOSS wrist movement)
interventional Spiegel score

Mashayekhi et al. Earplugs + eye mask Cross-over design, coronary ICU (n Subjective assessment: VSH Sleep quantity (score);
(2013), Iran total = 90), randomisation into 3 sleep quality (score)
groups: 1, eye mask; 2, earplugs; 3,
earplugs and mask

Yazdannik et al. Earplugs + eye mask Controlled clinical trial, not specified Subjective assessment: VSH Sleep quantity (score);
(2014), Iran ICU (n total = 50), 25 control and 25 sleep quality (score)
case group

Dave et al. (2015), Earplugs eye mask Cross-over design, coronary ICU (n Subjective assessment: RCSQ RCSQ score
India total = 50), group A: 25
group B: 25

Bajwa et al. (2015), Earplugs eye mask Randomized controlled trial, Subjective assessment: VSH Sleep quantity (score);
India unspecified ICU (n total = 100), 50 sleep quality (score)
control and 50 interventional

cf.: confer; REM: rapid eye movements; PSG: polysomnography; ICU: intensive care unit; 6-SMT: 6 sulphatoxymelatonin; po: per os;
SAI: Spielberger State Anxiety Inventory; PSQI*: Pittsburgh Sleep Quality Index: higher PSQI score means lower quality sleep; VSH:
Verran and Snyder–Halpern Sleep Scale; NEECHAM scale: the Neelon and Champagne Confusion Scale; RCSQ: Richard Campbell
Sleep Questionnaire; CAM-ICU: the Confusion Assessment Method for the ICU; RASS: Richmond Agitation Sedation Scale; SQS:
sleep quality scale; MOSS: medical outcomes study sleep; SS: Spiegel score; SD: standard deviation; dB: decibel; PACU:
post-anaesthesia intensive care unit; CI: confidence interval; OR: odds ratio; NA: not available.

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Results: interventions confer
(cf.) controls
Sleep quality: no statistically
significant difference between the
intervention and control groups
No significant difference, total
score (mean): intervention 3.9
(SD: 1.64) cf. 4.03 (SD: 0.96);
P = 0.32
Without direct evidence of
improvement in the subjectively
perceived quality of sleep in the
intervention group
Interventions were evaluated by
subjects (plugs in 22%, masks in
28%) as improving sleep
ACT: no evidence of significant
difference
Spiegel score: significant
improvement in intervention, 20
(SD: 4.1) cf. control 15 (SD: 5.0);
P = 0.006.
Sleep quantity: no statistically
significant difference
Sleep quality: statistically
significant improvement in the
observed components of
assessment (disturbance,
effectiveness, supplementation)
with one and/or both interventions
(sleep disturbance: intervention
84.5 cf. 140.1 controls, P < 0.05)
A statistically significant effect of
intervention on the individual
components of the assessment.
Sleep effectiveness: intervention
30.2 cf. controls 19.2; P < 0.05
Sleep disturbance: 53.2 cf. 34.5;
P < 0.001
Sleep quality improvement
Intervention 70.26 (SD: 5.89)/
68.74 (6.54) cf. controls 45.86
(4.86)/43.06 (7.31); P < 0.001
Statistically significant differences
in the individual assessment
components (intervention cf.
control)
Sleep fragmentation: 14.6 (SD:
3.44) cf. 4.19 (3.58); P < 0.01
Sleep latency: 6.05 (1.88) cf. 1.7
(1.66); P < 0.01
Sleep quality: 10.5 (2.52) cf. 2.14
(2.29); P < 0.01
Sleep length: 8.95 (2.47) 2.36
(2.47); P < 0.01
Sleep supplementation: 11.8 (3.26)
cf 4.1 (2.33); P < 0.01
ª 2017 European Sleep Research Society
Effect of the use of earplugs and eye mask in ICU
The effect size (Cohen’s d) for
the selected parameter
NA (there are no statistically
significant differences in
observed outcome parameters)
NA (there are no statistically
significant differences in
observed outcome parameters)
NA (there are no statistically
significant differences in
observed outcome parameters)
Spiegel score: 1.104315
Sleep disturbance: 0.06584
Sleep effectiveness: 6.74596
Sleep disturbance: 7.01358
4.51884/3.703926
Sleep fragmentation: 0.777623
Sleep latency: 3.315637
Sleep quality: 0.452705
Sleep length: 2.673422
Sleep supplementation: 0.271757
Other effects
Reduction of delirium incidence in
the intervention group: OR: 0.46
(95% CI: 0.23–0.89), P = 0.02)
Increased incidence of delirium-
free days: 1.64 (CI: 1.04–2.58),
P = 0.03) (no significant influence
on the length of hospitalization
and mortality)
Comfort: eye mask assessed as
uncomfortable (31 people), plugs
as well (29 people)
Noise: it was confirmed as the
most statistically significant
interfering factor in both the pre-
phase (50%) and post-phase
(52%) comfort
Interventions were rated as
comfortable
Statistically significant decrease in
morphine consumption in the
intervention group (27 (SD: 17 cf.
15 (12) mg, P = 0.02)
Best results achieved only with
earplugs (without masks)
Without statistically significant
reduction in analgesia/sedation
Comfort: 70% of patients report the
intervention as comforting
7
Conclusion
Selected interventions are a useful
tool to reduce delirium, a
subjective improvement in sleep
quality has not been confirmed
statistically
Interventions have a positive effect
on the quality of sleep, and can
be useful for defined patient
groups. Limitation of use in
practice consists in comfort
Interventions eliminate the
negative impact of the ICU
environment; their application
should be part of nursing
procedures.
Intervention in a PACU improves
the subjective sleep quality
(objectively unconfirmed)
Confirmed reduction in morphine
consumption (risk elimination)
The study confirms the positive
effect of the reviewed
interventions and supports their
integration into routine practice
The study confirms a subjective
improvement in the quality of
sleep in two subscales and does
not confirm its benefit in reducing
medication
The study confirms a better
subjective quality of sleep after
intervention compared to
standard care
The application of interventions
significantly improves the
subjective quality of sleep
8
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H. Locihova
All analysed studies were studies concerning examined
interventions—only plugs: five studies; only eye mask: two
studies; plugs and eye mask: nine studies; and plugs, mask
and music: three studies, individually or in combination (most
often against the control group with no intervention). The
groups included seven to 100 patients in ICUs (either general
or specialized) in tertiary (university) hospitals or in a sleep
laboratory. The total number of patients was 1379.
Where the format and method of the study allowed, the
statistically significant difference in the outcome of the
intervention group was expressed by the effect size using
Cohen’s d (MedCalc Software, Ostend, Belgium).
The results obtained allow an approximate and very
indicative comparison of the effect of the interventions
monitored across individual works, but due to the hetero-
geneity of the studies and their methodological limitations,
they are not analysed and discussed further.
An objective assessment of sleep quality measured by
PSG or ACT was found in four studies and provides
important information on the relationship of the effect of
intervention on the sleep architecture. All three experimental
studies confirmed the change in sleep architecture in healthy
volunteers, with noise exposure based on polysomnography
measurements.
An American experimental study (Wallace et al., 1999)
confirmed that the use of earplugs reduced rapid eye
movement (REM) latency significantly [(mean) without inter-
vention, 147.8 min, confer (cf.) mean after intervention
106.7 min, P = 0.02] and increased the percentage of REM
sleep statistically significantly (14.9% without intervention, cf.
19.9% with intervention, P = 0.04). The Chinese experimen-
tal study (Huang et al., 2015) confirmed a statistically
significant reduction in sleep onset latency (71.4 min  25.6,
cf. 46.6 min  21.6, P = 0.01) when applying the examined
intervention (earplugs and mask), lower number of awaken-
ings (15.1  3.3, cf. 10.5  3.2, P = 0.001) and a lower
sleep arousal index (number of awake reactions per hour)
(9.8  3.0, cf. 5.5  2.1, P = 0.000). Another experimental
Chinese study (Hu et al., 2010) confirmed the use of
earplugs and eye masks to increase the percentage of
REM sleep statistically significantly (9.3%  4.3 without inter-
vention, cf. 12.9  4.3% with intervention, P = 0.005), REM
latency reduction (min) (146.9  56.2, cf. 105.7  47.0,
P = 0.013) and a lower sleep arousal index (15.1  6.2, cf.
12.2  6.5, P = 0.04). The French randomized study (Le
Guen et al., 2014) carried out on the post-anaesthesia care
unit (PACU) evaluated the objective parameters of the effect
of the intervention (earplugs and mask, cf. routine care) using
an ACT device on a non-dominant limb for 12 h (20:00–
8:00 hours) on the first postoperative night. Based on the
results, there was no statistically significant difference
between the intervention/controlled group.
Three studies used levels of melatonin metabolite (6-SMT:
6-sulphatoxymelatonin) cortisol in urine/serum as an objec-
tive and quantifiable parameter. In a study by Hu et al.
(2010), two samples were taken at 22:00 and 7:00 hours
during the observed nights. The study showed evidence of a
positive effect of eye mask and earplugs on melatonin
secretion (P = 0.002; cortisol without statistically significant
change, P = 0.14). Huang et al. (2015) evaluated the mela-
tonin levels in the serum (samples taken at 20 : 50 and
22:00–06:00 hours every hour over three nights). The
melatonin level in the serum was reduced statistically
significantly after ICU simulation exposure (P < 0.05). In
the observed group with exogenous melatonin substitution
(1 mg after) at 21:00 hours, a statistically significantly higher
maximum level (P < 0.001) was confirmed. The authors
consider the exogenous melatonin substitution as a more
effective method than the isolated use of earplugs and eye
masks. A randomized controlled study (Hu et al., 2015a,b)
for the period of 2 nights (before and after intervention) in a
surgical ICU analysed the collection of night urine (12 h from
20:00 to 08:00 hours) to 6-SMT and cortisol. There were no
statistically significant differences in the intervention/con-
trolled groups at the levels of nightly secretion of selected
hormones.
Sleep quality was evaluated subjectively most frequently
using different questionnaires (six authors used original
questionnaires and 12 used standardized questionnaires).
The results were then analysed statistically and statistical
significance verified.
Three authors used the Richards Campbell Sleep Ques-
tionnaire (RCSQ): in their study, Hu et al. (2015a,b) con-
firmed a statistically significant improvement in subjective
sleep quality in all five items of the intervention group
(P < 0.05). Dave et al. (2015) confirmed a better overall
RCSQ score for the duration of interventions (P < 0.001),
while the questionnaire in the study by Kamdar et al. (2013)
did not confirm statistically the improvement in the subjective
quality of sleep after interventions [pre-54.5 (27.1), cf. post-
53.2 (27.3), P = 0.25].
Five authors used the Verran and Snydern Halpern Sleep
Scale (VSH) in various modifications. Scotto et al. (2009) and
Ryu et al. (2011) used the eight-item version. The first study
confirmed a statistically significant improvement in the total
sleep score for the intervention group (P = 0.002) and
confirmed a statistically significant improvement in seven of
eight items. In the experimental group, the second study
confirmed a longer sleep duration (279.31  43.99/
243.10  42.68, t = 3.18, P = 0.002) and differences in sleep
quality (36.14  5.68/29.41  3.85, t = 5.26, P < 0.001).
Mashayekhi et al. (2013), Yazdannik et al. (2014) and Bajwa
et al. (2015) used the 16-item version. The first study
confirmed statistical improvement in subjectively perceived
sleep quality in all three subscales (disturbance, effective-
ness, supplementation) (P < 0.05). The second study con-
firmed the statistically significant effect of intervention on the
subscales of effectiveness and disturbance (P < 0.001), but a
statistically significant difference in the supplementation
subscale was not confirmed. The third study confirmed a
statistically significant improvement in all three subscales
(disturbance, effectiveness, supplementation) (P < 0.001).
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Three authors (Babaii et al., 2015; Daneshmandi et al.,
2012; Neyse et al., 2011) used the Pittsburgh Sleep Quality
Index (PSQI). The first study confirmed statistically significant
differences in five of the seven monitored domains
(P < 0.05), the second study confirmed a significant improve-
ment in sleep quality after intervention in the total sleep
quality score (10.46  4.09/4.86  1.88, P < 0.000) and the
third study was in agreement with the results of the second
study with the total sleep quality score (10.3  6.3/6.3  2.1,
P < 0.001).
One author, Le Guen et al., 2014, used the Medical
Outcome Study Scale (MOSS) and the Spiegel Scale (SS)
and confirmed a statistically significant improvement after the
intervention [20 (4)/15 (5), P = 0.006].
Some authors (Haddock, 1994; Hu et al., 2010; Huang
et al., 2015; Jones and Dawson, 2012; Richardson et al.,
2007; Van Rompaey et al., 2012) used their original ques-
tionnaires, which included a different number of items (five to
12) with a different content focus, and in many cases they
represented an additional method for objective assessment
or sleep was determined as a secondary outcome. Due to the
significant variability or absence of their detailed specifica-
tions, questionnaires will not be analysed in more detail.
However, there is a consensus on the positive effect of the
interventions under investigation on the subjective quality of
sleep.
In most of the works studied, a statistically significant
difference was found in the key observed parameters
describing the subjective quality of sleep, which is evidence
of the observed measures supporting sleep.
Some of the observed works set out other partial goals of
delirium incidence (three studies). A Belgian randomized
study (Van Rompaey et al., 2012) confirmed the strong
benefit of the observed intervention (earplugs) in reducing the
incidence of confusion and early delirium during the night.
Cox regression analysis revealed a reduction in the risk of
early development of delirium and confusion by 53% [hazard
ratio (HR): 0.47 (95% confidence interval (CI): 0.27–0.87].
The study confirmed that patients in the intervention group
experienced a significant improvement in subjective sleep
quality during the first night observed (P = 0.042). An
American observational study with a pre- and post-design
(Kamdar et al., 2013) confirmed a statistically significant
reduction in the delirium incidence of the investigated
interventions: pre-phase: (22%), cf. post-phase (49%; OR:
0.46, 95% CI: 0.23–0.89, P = 0.02) and confirmed a statis-
tically significant difference in the occurrence of the daily
delirium-free status in patients in the pre-phase (43%) cf.
post-phase (48%; OR: 1.64, 95% CI: 1.04–2.58, P = 0.03). A
French randomized study (Le Guen et al., 2014) confirmed a
statistically significant reduction in the incidence of postop-
erative disorientation in the intervention group (control group
14%, cf. intervention group 0%, P = 0.01).
Medication consumption as a subtarget was observed in
three studies. An Iranian study (Yazdannik et al., 2014) did
not confirm the statistically significant decrease in narcotics
ª 2017 European Sleep Research Society
Effect of the use of earplugs and eye mask in ICU 9
(pharmaceuticals not specified in more detail) after interven-
tion (earplugs and mask) in the groups (3.12 mg narcotics cf.
2.32 mg narcotics, P = 0.282). Conversely, another Iranian
study (Neyse et al., 2011) confirmed the positive effect of this
intervention on the consumption of sleep medications (phar-
maceuticals not specified in more detail) (before 1.6  0.89/
after 0.93  0.58, P = 0.04). The results are in agreement
with the French study (Le Guen et al., 2014), which
confirmed the reduced consumption of morphine [27 (17)
mg and 15 (12) mg, P = 0.02].
DISCUSSION
Selection of the evaluation tool is a very important influencing
factor when evaluating the studies. It is apparent from the
studies included in this review that the authors used different
techniques to evaluate sleep quality. Three studies (Hu et al.,
2010; Huang et al., 2015; Wallace et al., 1999) used the
method of objective evaluation by a polysomnography device
(PSG) alone or in combination with other methods. A
significant limitation of these studies is their experimental
nature. In the above studies, the effect of the observed
interventions on sleep architecture was confirmed: the
number and duration of REM phases, the proportion of
REM and non-REM phases, the REM sleep latency and the
number of arousals. A study (Le Guen et al., 2014) at the
PACU used a combination of the objective sleep evaluation
by ACT and subjective evaluation; this study did not confirm
the objective changes in the sleep quality and quantity
monitored with ACT, although the patients reported improve-
ment subjectively (confirmed by a significant decrease in
morphine consumption during the first 24 h after intervention
in the intervention group). The benefit and suitability of ACT
as a tool for the objective assessment of sleep quality is
questionable in conditions of intensive and peri-operative
care, as the rate of self-motor activity is reduced significantly
by the somatic condition of the patients (postoperative
condition, pain, acute critical illness, etc.) and drugs damp-
ening the central nervous system (analgesia, sedation).
In the authors’ attempt to objectify the impact of the
assessment of investigated interventions, studies evaluating
the levels of selected hormones (cortisol, melatonin) and their
metabolites (6-SMT in serum/urine) were carried out. The
differences in methodology (healthy volunteers and patients),
collections and study design represent major limitations, and
it can be assumed that the severity of patients’ diseases can
distort and affect levels of these hormones significantly.
From the available studies in this overview it is clear that
the authors most often used various subjective techniques to
evaluate the sleep quality. One of the outcomes of this review
is the confirmation of the significant variability in the selection
of a subjective assessment tool: an original questionnaire
focused on subjective sleep quality was developed in six
studies and standardized questionnaires (with available
psychometric data) in 12 studies. Due to different character-
istics and methodological inconsistencies, the analysed
10
et al.
H. Locihova
works were not analysed systematically according to the
recommended and accepted methodology (Ryan et al.,
2013). Significant differences in the design of the evaluation
of the sleep quality in individual studies do not allow for a full
comparative systematic statistical meta-analysis.
Despite the significant variability of the assessment tools, it
can be concluded from comparison of the obtained results
that there is agreement between the studies on the positive
effect of interventions on the subjective quality of sleep
(clinically significant impact of the examined intervention
confirmed). In terms of bias and confounding factors it is
necessary to take into account the number of nights
monitored. The number of nights monitored in the reviewed
studies ranged from one to eight. For the purpose of critical
analysis of the nights observed, in the study by Van
Rompaey et al. (2012) a positive effect of the intervention
was confirmed only during the first day of hospitalization (2–4
nights without subjective improvement); other studies did not
confirm or evaluate this phenomenon.
Three studies (Kamdar et al., 2013; Le Guen et al., 2014;
Van Rompaey et al., 2012) confirm that the examined
interventions reduce the incidence of delirium significantly.
These outcomes are in agreement with the observational
study by Patel et al. (2014) and the meta-analysis by Litton
et al. (2016), which confirmed the positive effect of a multi-
component treatment protocol with the emphasis on the need
for sleep and delirium. The additional positive effect can be
attributed to the mechanism of action of the observed
interventions (reduction of the noise and light transmission)
and thus to the reduction of noxious harmful effects.
In order to integrate and assess effectiveness, the comfort
of the method was monitored in seven studies. In the studies
by Scott et al. (2009) and Richardson et al. (2007), the
respondents evaluated the method as uncomfortable, and in
the study by Huang et al. (2015) discomfort was confirmed
only in the case of earplugs (eye mask evaluated as
comfortable). In the remaining studies, respondents rated
the interventions as comfortable.
When evaluating the effect, three studies assessed their
effect on sleep/analgesic medication. A causal relationship of
medical reduction was confirmed in the intervention group in
two reviewed studies (Le Guen et al., 2014; Neyse et al.,
2011); one study did not confirm this relation (Yazdannik
et al., 2014). The absence of specific drug groups (two
studies) is an important limitation for the evaluation of the
effect being studied. The positive effect of the sleep protocol
on sedative consumption was also confirmed significantly in
many previous studies.
In nursing practice, there is a number of other alternative
techniques available to achieve the highest possible sleep
quality in an ICU. Alternative and complementary practices in
patient care are becoming increasingly important in both the
non-professional and professional community, where a par-
ticular role is beginning to be attributed to them according to
the principles of evidence-based medicine (EBM). The most
important non-pharmacological sleep-promoting strategies
that can be used in an ICU include music therapy, aro-
matherapy, acupressure, massage, phototherapy, relaxation
and the integration of hygiene protocol of sleep care (Hu
et al., 2015a,b).
There is no principle focused on the need for a sleep
set-up in the Czech Republic. There are somewhat partial
efforts to put non-pharmacological interventions (earplugs,
eye masks) into practice. The current recommendation of
the Czech Society of Intensive Care Medicine, which is
based on a global recommendation on sedating adult
patients in an ICU, stipulates that achieving and maintain-
ing sleep with the use of all available measures should be
an integral part of the comprehensive procedure for all
patients in an ICU.
Limitations of the study and recommendations
This study includes only findings published in the English
language and in available databases. The quality of the
present literary evidence is limited by a lower number of quality
works. Critically assessing the level of the evidence quality, it
can be stated that the variability in the design of the studies is a
serious limitation of the overview. Differences in quality sleep
assessment methodology in individual studies do not allow
for a full comparative systematic statistical meta-analysis.
For a valid assessment of the contribution of the sleep
supporting interventions in intensive care (compared to
standard nursing procedures) a high-quality, multi-centric,
randomized study would be needed.
Implications for practice
 Sleep disorders are extremely frequent among all ICU
patients compared to the general ward patient population
 Sleep deprivation and disturbed sleep quality have clear
and straightforward consequences for patients’ level of
distress
 Interventions improving the quality of sleep could affect the
global critical care outcome of ICU survivors and should be
a part of good-quality clinical practice in the future
 Selection of non-pharmacological sleep-promoting inter-
ventions (earplugs, eye masks) may have a beneficial
effect on subjectively perceived sleep quality
CONCLUSION
Lack of sleep of adequate quality and length in an ICU is a
significant negative factor affecting the quality of provided
care. Saturation of the need for sleep is in many ways
extremely problematic, due especially to the difficulty of
evaluating sleep quality. However, at present, literary works
agree on the importance of non-pharmacological strategies
used for inducing sleep in ICUs.
Analysis of identified studies suggests that the observed
non-pharmacological interventions (earplugs and eye mask)
ª 2017 European Sleep Research Society
 Effect of the use of earplugs and eye mask in ICU
may have a positive effect on the subjective sleep quality of
patients in an ICU. A large number of other quality studies
would be necessary to confirm this.
CONFLICT OF INTEREST
The authors declare that there are no conflicts of interest
regarding the surveillance study and ethical aspects were
respected while processing the results.
AUTHOR CONTRIBUTIONS
Concept and design (HL), data collection (HL), analysis and
interpretation of the data (HL, KA), processing and design of
the manuscript (HL, KA), supervision (HP), critical revision of
the manuscript (JF).
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