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Title of the Study
Efficacy of earplugs and eye mask on quality of
sleep at night among patients in cardiac surgical intensive care unit.
Problem Statement
A
randomized control trial to assess the efficacy of earplugs and eye mask on
quality of sleep at night among patients in cardiac surgical intensive care
unit of a tertiary care hospital
Research
Questions
Will the use of earplugs and eye mask affect
the quality of sleep at night among patients in cardiac surgical intensive care
unit of a tertiary care hospital?
Hypothesis
H0:- There is no difference in the quality of sleep at night with
the use of earplugs and eye masks among
patients in cardiac surgical intensive care unit of a tertiary care hospital
H1:- There is difference in the quality of sleep at night with the
use of earplugs and eye masks
among patients in cardiac surgical intensive care unit of a tertiary care
hospital
Introduction
Adequate sleep is essential to survival of
all mammals. Sleep provides necessary restorative, protective, and
energy-conserving functions. Sleep consists of 2 main types: rapid eye movement
(REM) sleep and non rapid eye movement (NREM) sleep. Sleep “architectureâ€
consists of several recurring 90-minute cycles of NREM and REM sleep. A person
undergoes four or five cycles of sleep each night. Sufficient quantities of both
NREM and REM sleep stages are necessary for restoration of mental and physical
processes.
Most common complaint of
patients who survive a critical illness is disrupted sleep in the ICU. A study
conducted by Sinha S et al1 (2015) in AIIMS, New Delhi showed sleep
disturbance in medical ICU to be 47%. Circadian rhythm was disturbed, only
55.3% of sleep was noted in the night.
Delaney JL et al2 (2015) in the review on impact of Sleep disturbance
in ICU patients suggests that there exist a multitude of factors that
contribute to sleep disturbance in ICU, which include noise levels, clinical
interactions and effects of light. They recommend further clinical research to
identify effective strategies to curtail the impact of the clinical environment
on patient’s ability to sleep.
As early as in the
19th century, Florence Nightingale (1859) stated that unexpected noise harms
the patient and over the years studies have investigated this premise and confirmed
that high sound levels and disturbing noise negatively affect both the physical
health and psychological wellbeing. Acoustic studies have shown mean levels of
between 50 and 65 db above the patient’s head, a level comparable to that of a
busy road. Johansson L et al3 (2012) interviewed 16 patients
discharged from ICU about their sound experience and 40% of patients recalled
noise from the time in the ICU and that 65% of these reported that they were
very disturbed by it.
Light
exposure is another important sleep disruptor in ICU settings. Reported
nocturnal illumination in ICUs varies widely, with mean maximum levels of 5 to
1400 lux. Light exposure is the primary external cue for circadian rhythm. In
addition, nocturnal melatonin secretion can be acutely suppressed by light, and
100 lux is sufficient to impact nocturnal melatonin secretion.
Sleep is essential to recovery and is also
important for many somatic, cognitive and psychological processes. Despite
this, very little has been done in recent years to prevent sleep deprivation in
ICUs. If we want to help patients in ICUs to recover, promoting sleep is the
challenge of the future. Therefore, effective interventions to promote sleep in
ICU patients are urgently needed. Despite many claims that the use of noise
reduction and lighting practice in an intensive care environment may improve
the patient’s sleep quality, there have been few objective studies to evaluate
the effects of these interventions. The environment of the intensive care unit
is frequently ignored as a key factor in patient well-being. Staff members may
not recognize the significant disruption caused by care activities, noise at
night, and disrupted day/night light patterns. For many years, architects or hospital
planners have neglected appropriate sound insulation or the inclusion of
sources of natural light to reinforce the day/night cycle. As a result for many
critical care environments, it may be important to accept that environmental
change will take years to effect and will be expensive. Therefore, simple and low-cost
patient interventions, such as the use of earplugs and eye masks, may be a
pragmatic solution for many.
Review of Literature
Guen ML et al4 (2014)
conducted a study in 46 post operative patients in Post anaesthesia care unit (PACU).
They were randomized to sleep with or without protective devices and sleep
quality was measured by sleep quality scales and nurses’ assessment. They
concluded that earplugs and eye masks applied in the PACU significantly
preserve sleep quality.
A randomized clinical trial done
by Rompaey BV et al5 (2012) included adult intensive care patients-
an intervention group of 69 patients sleeping with earplugs during the night
and a control group of 67 patients sleeping without earplugs during the night.
They found out that the use of earplugs during the night lowered the incidence
of confusion in the studied intensive care patients. A vast improvement was
shown by a Hazard Ratio of 0.47 (95% confidence interval (CI) 0.27 to 0.82).
Also, patients sleeping with earplugs developed confusion later than the
patients sleeping without earplugs. While eye masks might improve sleep in
selected patients, it also may lead to feelings of discomfort and anxiety in
mechanically ventilated ICU patients and therefore its standardized use need
further research.
Hu RF et al6 (2015)
conducted a study on fifty patients who underwent a scheduled cardiac surgery.
They were randomized to sleep with or without earplugs and eye masks combined
with 30-minute relaxing music during the postoperative nights in CSICU. Urine
was analyzed for nocturnal melatonin and cortisol levels. Subjective sleep
quality was evaluated using the Chinese version of Richards-Campbell Sleep
Questionnaire (a visual analog scale, ranging 0–100). The results showed significant
differences between groups in depth of sleep, falling asleep, awakenings and overall
sleep quality (P <0.05). Perceived sleep quality was better in the
intervention group.
Huang HW et al8 (2015)
conducted a study on 40 healthy subjects in a simulated ICU environment to
determine the effect of simulated ICU noise and light on nocturnal sleep
quality, and compare the effectiveness of melatonin and earplugs and eye masks
on sleep quality in these conditions in healthy subjects. The objective sleep
quality was measured by polysomnography and serum melatonin levels. Subjects
rated their perceived sleep quality and anxiety levels. Results showed both
melatonin and earplugs and eye masks improved perceived sleep quality and
anxiety level (P= 0.000).
Lin Y et al11 (2016) did
a study in Fujian, China to investigate the effects of non-drug interventions
on the sleep quality of patients after mechanical cardiac valve implantation.
In this prospective, randomized, controlled trial, 64 patients scheduled for
mechanical mitral valve replacement were recruited. Patients underwent
cognitive behavioural therapy and wore noise cancelling earplugs and eye mask.
The primary outcome was the total sleep quality score differences between the
4th day after admission and the 5th day after operation. Overall sleep quality
in the intervention group was better than in the control group on the 5th day
after operation. The subjective sleep quality of the patients in each group was
significantly lower on the 5th day after the operation than on the 4th day
after admission (P <0.05). They concluded that non-drug intervention
could improve the sleep quality of patients after mechanical cardiac valve
implantation and help the postoperative recovery of the patients.
Pulak and Jensen14 (2016) in their
article review (Journal of intensive care) suggests an
interaction between sleep, delirium, and morbidity and mortality in the
critically ill patients. Attempting to ascertain the relative importance of
restorative sleep, within the framework of critically ill patients, multiple co
morbidities, and polypharmacy, remains a difficult challenge. A vast body of
data suggests an impact of sleep patterns on immune mechanisms, respiratory
function, hormonal homeostasis, metabolism, and neurocognition. Furthermore,
disrupted sleep in the critical care setting is perceived by patients to be
extremely distressing. Until such time that the impact of disrupted sleep in
the critical care setting is better explained, it is appropriate to provide
patients with consolidated, restorative sleep, if this can be safely achieved.
Therapy should be directed at all potential causes of sleep deprivation, with
particular attention given to creating an environment that is both diurnal and
conducive to sleep.
Objectives of the study
1.
Assess
quality of sleep at night among patients in cardiac surgical ICU of a tertiary
care hospital, sleeping without eye mask and earplugs.
2.
Assess
quality of sleep at night among patients in cardiac surgical ICU of a tertiary
care hospital, sleeping with eye mask and earplugs.
3. Compare the efficacy of earplugs and eye mask
on quality of sleep at night among patients in cardiac surgical ICU
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