Sleeping Over Sleep in ICU:will eye mask and earplugs help?
- Conditions
- Patients undergoing cardiac surgery
- Registration Number
- CTRI/2017/10/009996
- Lead Sponsor
- Organization
- Brief Summary
**Title of the Study**
Efficacy of earplugs and eye mask on quality ofsleep at night among patients in cardiac surgical intensive care unit.
**Problem Statement**
Arandomized control trial to assess the efficacy of earplugs and eye mask onquality of sleep at night among patients in cardiac surgical intensive careunit of a tertiary care hospital
**ResearchQuestions**
Will the use of earplugs and eye mask affectthe quality of sleep at night among patients in cardiac surgical intensive careunit of a tertiary care hospital?
**Hypothesis**
H0:- There is no difference in the quality of sleep at night withthe use of earplugs and eye masks amongpatients in cardiac surgical intensive care unit of a tertiary care hospital
H1:- There is difference in the quality of sleep at night with theuse of earplugs and eye masksamong patients in cardiac surgical intensive care unit of a tertiary carehospital
**Introduction**
Adequate sleep is essential to survival ofall mammals. Sleep provides necessary restorative, protective, andenergy-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 personundergoes four or five cycles of sleep each night. Sufficient quantities of bothNREM and REM sleep stages are necessary for restoration of mental and physicalprocesses.
Most common complaint ofpatients who survive a critical illness is disrupted sleep in the ICU. A studyconducted by Sinha S et al1 (2015) in AIIMS, New Delhi showed sleepdisturbance in medical ICU to be 47%. Circadian rhythm was disturbed, only55.3% of sleep was noted in the night.
Delaney JL et al2 (2015) in the review on impact of Sleep disturbancein ICU patients suggests that there exist a multitude of factors thatcontribute to sleep disturbance in ICU, which include noise levels, clinicalinteractions and effects of light. They recommend further clinical research toidentify effective strategies to curtail the impact of the clinical environmenton patient’s ability to sleep.
As early as in the19th century, Florence Nightingale (1859) stated that unexpected noise harmsthe patient and over the years studies have investigated this premise and confirmedthat high sound levels and disturbing noise negatively affect both the physicalhealth and psychological wellbeing. Acoustic studies have shown mean levels ofbetween 50 and 65 db above the patient’s head, a level comparable to that of abusy road. Johansson L et al3 (2012) interviewed 16 patientsdischarged from ICU about their sound experience and 40% of patients recallednoise from the time in the ICU and that 65% of these reported that they werevery disturbed by it.
Lightexposure is another important sleep disruptor in ICU settings. Reportednocturnal illumination in ICUs varies widely, with mean maximum levels of 5 to1400 lux. Light exposure is the primary external cue for circadian rhythm. Inaddition, nocturnal melatonin secretion can be acutely suppressed by light, and100 lux is sufficient to impact nocturnal melatonin secretion.
Sleep is essential to recovery and is alsoimportant for many somatic, cognitive and psychological processes. Despitethis, very little has been done in recent years to prevent sleep deprivation inICUs. If we want to help patients in ICUs to recover, promoting sleep is thechallenge of the future. Therefore, effective interventions to promote sleep inICU patients are urgently needed. Despite many claims that the use of noisereduction and lighting practice in an intensive care environment may improvethe patient’s sleep quality, there have been few objective studies to evaluatethe effects of these interventions. The environment of the intensive care unitis frequently ignored as a key factor in patient well-being. Staff members maynot recognize the significant disruption caused by care activities, noise atnight, and disrupted day/night light patterns. For many years, architects or hospitalplanners have neglected appropriate sound insulation or the inclusion ofsources of natural light to reinforce the day/night cycle. As a result for manycritical care environments, it may be important to accept that environmentalchange will take years to effect and will be expensive. Therefore, simple and low-costpatient interventions, such as the use of earplugs and eye masks, may be apragmatic 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 sleepquality was measured by sleep quality scales and nurses’ assessment. Theyconcluded that earplugs and eye masks applied in the PACU significantlypreserve sleep quality.
A randomized clinical trial doneby Rompaey BV et al5 (2012) included adult intensive care patients-an intervention group of 69 patients sleeping with earplugs during the nightand 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 incidenceof confusion in the studied intensive care patients. A vast improvement wasshown 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 thepatients sleeping without earplugs. While eye masks might improve sleep inselected patients, it also may lead to feelings of discomfort and anxiety inmechanically ventilated ICU patients and therefore its standardized use needfurther 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 combinedwith 30-minute relaxing music during the postoperative nights in CSICU. Urinewas analyzed for nocturnal melatonin and cortisol levels. Subjective sleepquality was evaluated using the Chinese version of Richards-Campbell SleepQuestionnaire (a visual analog scale, ranging 0–100). The results showed significantdifferences between groups in depth of sleep, falling asleep, awakenings and overallsleep quality (P <0.05). Perceived sleep quality was better in theintervention group.
Huang HW et al8 (2015)conducted a study on 40 healthy subjects in a simulated ICU environment todetermine the effect of simulated ICU noise and light on nocturnal sleepquality, and compare the effectiveness of melatonin and earplugs and eye maskson sleep quality in these conditions in healthy subjects. The objective sleepquality was measured by polysomnography and serum melatonin levels. Subjectsrated their perceived sleep quality and anxiety levels. Results showed bothmelatonin and earplugs and eye masks improved perceived sleep quality andanxiety level (P= 0.000).
Lin Y et al11 (2016) dida study in Fujian, China to investigate the effects of non-drug interventionson the sleep quality of patients after mechanical cardiac valve implantation.In this prospective, randomized, controlled trial, 64 patients scheduled formechanical mitral valve replacement were recruited. Patients underwentcognitive behavioural therapy and wore noise cancelling earplugs and eye mask.The primary outcome was the total sleep quality score differences between the4th day after admission and the 5th day after operation. Overall sleep qualityin the intervention group was better than in the control group on the 5th dayafter operation. The subjective sleep quality of the patients in each group wassignificantly lower on the 5th day after the operation than on the 4th dayafter admission (*P* <0.05). They concluded that non-drug interventioncould improve the sleep quality of patients after mechanical cardiac valveimplantation and help the postoperative recovery of the patients.
Pulak and Jensen14 (2016) in theirarticle review (Journal of intensive care) suggests aninteraction between sleep, delirium, and morbidity and mortality in thecritically ill patients. Attempting to ascertain the relative importance ofrestorative sleep, within the framework of critically ill patients, multiple comorbidities, and polypharmacy, remains a difficult challenge. A vast body ofdata suggests an impact of sleep patterns on immune mechanisms, respiratoryfunction, hormonal homeostasis, metabolism, and neurocognition. Furthermore,disrupted sleep in the critical care setting is perceived by patients to beextremely distressing. Until such time that the impact of disrupted sleep inthe critical care setting is better explained, it is appropriate to providepatients with consolidated, restorative sleep, if this can be safely achieved.Therapy should be directed at all potential causes of sleep deprivation, withparticular attention given to creating an environment that is both diurnal andconducive to sleep.
**Objectives of the study**
1. Assessquality of sleep at night among patients in cardiac surgical ICU of a tertiarycare hospital, sleeping without eye mask and earplugs.
2. Assessquality of sleep at night among patients in cardiac surgical ICU of a tertiarycare hospital, sleeping with eye mask and earplugs.
3. Compare the efficacy of earplugs and eye maskon quality of sleep at night among patients in cardiac surgical ICU
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
Orientation to time and place Ability to attend study(wearing eyemask and ear plugs.
Any injuries to eyes and ears Allergy to earplugs or eye mask Sleep disorders Neurological disorders Unwilling patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase in quality of sleep 0900 hrs in the morning after interventional night
- Secondary Outcome Measures
Name Time Method Increase in quality of sleep second day of surgery
Trial Locations
- Locations (1)
MH CTC
🇮🇳Pune, MAHARASHTRA, India
MH CTC🇮🇳Pune, MAHARASHTRA, IndiaMaj Vidhya PPrincipal investigator8601428619vidhyanair_007@yahoo.co.in