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IRCT2014061717237N2 IRCT 2014-10-15 Deputy of Research and Technology The Effects of Ear Plug and Eye Mask on Patients' Nocturnal Sleep Quality The Effects of Ear Plug and Eye Mask on Nocturnal Sleep Quality in Patients of Cardiac Intensive Care Unit 2014-03-18 anticipated 68 Complete https://irct.ir/trial/15894 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomization strategies: Considering age, gender and cause of hospitalization, patients were allocated to three matched intervention groups (eye mask, ear plug and both eye mask and ear plug) and control group. Allocation will be achieved using stratified random allocation. 3 Ischaemic Heart Diseases. Intervention 1: Eye Mask Group: For this group of patients, in addition to routine care, eye mask (made of black cloth) will be used from 22 pm on the third day of hospitalization to 7 am of next day. Intervention 2: Ear Plugs Group: For this group of patients, in addition to routine care, the ear plug (Elvex Mark، Quattro model, four-step ،lace) will be used from 22 pm on the third day of hospitalization to 7 am of next day. Intervention 3: Ear Plugs and Eye Mask Group: For this group of patients, in addition to routine care, eye mask and ear plug will be used from 22 pm on the third day of hospitalization to 7 am of next day simultaneously. Intervention 4: Control group, without any intervention. Background: Sleep is a basic human need and factors related to the physical environment are one of the major causes of sleep disorder in patients of cardiac intensive care units. In this study the effect of using eye mask and earplugs on the quality of nocturnal sleep, melatonin and cortisol in cardiac intensive care unit patients were studied.<br /> Materials and Methods: This randomized clinical trial was done in 68 patients of cardiac intensive care unit at a Kordkoy Hospital in 2014. At first, the lighting and the sound of the cardiac intensive care unit was measured for 24 hours in two days. The quality of nocturnal sleep for all participants with VSH-scale was investigated at the second night of admission, as well as urine melatonin and cortisol levels was measured between the hours of 22 pm to 7 am. Participants at the third night of admission were randomly divided into four groups (three experimental groups and one control group). For patients in the intervention groups, respectively eye mask, earplugs and both eye mask and earplugs was used in addition of usual care and there was no intervention for control group. Sleep quality, urine melatonin and cortisol levels in experimental and control group was measured. The data was analyzed in SPSS-16 using ANOVA, ANCOVA and Shapiro-Wilk test.<br /> Results: The mean score of sleep quality showed a significant difference before and after the intervention in all intervention groups (P
public Somayeh Rezvani Khorshidi
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan
Gorgan 09115735519 Iran (Islamic Republic of) 4917136536 +98 17 3242 6900 rezvani_khorshidi@yahoo.com Golestan University of Medical Sciences scientific Mahnaz Modanloo
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan
Gorgan Iran (Islamic Republic of) 4917136536 +98 17 3242 6900 modanloo.mahnaz@goums.ac.ir; modanloo1@yahoo.com Golestan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age between 18 and 65 years old, consciousness, orientation to time and place, have no sleep disorders, have no visual and hearing problem, the absence of psychiatric disorders, have no history of night-shift work at least in past 3 years, no use of coffee, alcohol and hypnotic medication at least 12 hours before the study time. Exclusion criteria: Occurrence of sleep disorders during study period (such as sleep apnea, narcolepsy, restless leg syndrome), use of hypnotic medication during study period, the onset of menstruation in female patients during the study, patients who will be discharged or died during the study, sleeping confounding medications (e.g., opiates, amphetamines), receive tranquilizers and anesthetics, cardiopulmonary resuscitation during the study. 17 years 65 years Both I24 Other acute ischemic heart diseases Prevention Prevention Prevention Prevention Eye Mask Group: For this group of patients, in addition to routine care, eye mask (made of black cloth) will be used from 22 pm on the third day of hospitalization to 7 am of next day. Ear Plugs Group: For this group of patients, in addition to routine care, the ear plug (Elvex Mark، Quattro model, four-step ،lace) will be used from 22 pm on the third day of hospitalization to 7 am of next day. Ear Plugs and Eye Mask Group: For this group of patients, in addition to routine care, eye mask and ear plug will be used from 22 pm on the third day of hospitalization to 7 am of next day simultaneously. Control group, without any intervention. Sleep. Timepoint: Before and a day after intervention. Method of measurement: Verran and Snyder Halpern Sleep Scale. Melatonin. Timepoint: Before and a day after intervention. Method of measurement: The measurement of urinary melatonin. Cortisol. Timepoint: Before and a day after intervention. Method of measurement: The measurement of urinary cortisol. Deputy of Research and Technology Approved 2014-03-18 Ethical Committee Deputy of Research and Technology, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan Gorgan Iran (Islamic Republic of)