The effect of using earplugs and eye masks during night on sleep quality, anxiety and onset of delirium in hospitalized patients in ICU at Imam Reza and Qaem hospitals in Mashhad
Determining the effect of using an earplugs and eye mask on the quality of sleep, anxiety and delirium in patients hospitalized to the intensive care unit
Design
Two arm parallel group randomised trial with blinded care and outcome assessment
Settings and conduct
This study will be conducted in ICU in Qa'im and Imam Reza hospitals in Mashhad. All doctors and nurses in intensive care units will be aware of the research process and, for further certainty, a poster that summarizes the study process will be installed in any special section where it is appropriate and visible. In beginning of study and before sleep, baseline information from patients in both groups is collected by a group of researchers who are not aware of the type of study group (control and intervention). Nurses and patients will be asked to do not inform the researchers about the use or non-use of eye masks and earplugs in order to avoid the potential impact of their knowledge on the results of the study.
Participants/Inclusion and exclusion criteria
Orientation, GCS higher than 10, hospitalization to the intensive care unit for more than 72 hours, lack of any known cognitive impairment such as dementia, dizziness and delirium at the time of admission, lack of sleep disorders such as sleep apnea, narcolepsy, chronic insomnia and restless leg syndrome
Intervention groups
At 22 o'clock for 3 nights, the nurse will be reminded to use an ear tag and eye mask for the intervention group and at 6 o'clock in the morning to help the patient remove it and, where appropriate, in the wardrobe of the patient and out of the view. The control group will not use the same nights before a specific device.
Main outcome variables
quality of sleep, anxiety and delirium
General information
Reason for update
Acronym
ICU
IRCT registration information
IRCT registration number:IRCT20190407043189N1
Registration date:2019-05-25, 1398/03/04
Registration timing:retrospective
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Mahnaz Bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1443
Email address
bahramim@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
2015-01-21, 1393/11/01
Actual recruitment end date
2015-06-20, 1394/03/30
Trial completion date
2015-06-23, 1394/04/02
Scientific title
The effect of using earplugs and eye masks during night on sleep quality, anxiety and onset of delirium in hospitalized patients in ICU at Imam Reza and Qaem hospitals in Mashhad
Public title
The effect of earplugs and eye masks on sleep quality, anxiety and onset of delirium in hospitalized patients in ICU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient has Orientation
GCS higher than 10
The patient is hospitalized to the intensive care unit for more than 72 hours
The patient has the ability to put an earplugs and eye mask independently
Exclusion criteria:
The patient has any known hearing impairment
The patient will have any known cognitive impairment such as dementia, dizziness and delirium at the time of admission
The patient has any sleep disturbances such as sleep apnea, narcolepsy, chronic insomnia and restless leg syndrome at the start of the study
The patient has an addiction to any drug
The patient has a history of night work during the past 3 years
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignments will be made using the production of random online numbers on the relevant websites. Before the study, the researchers agreed that the first time random numbers were assigned to the control group and the second time to the intervention group.
At first, the range of numbers is from 1 to 80, and then 40 random numbers for the control group and again 40 random numbers for the intervention group will be selected.The option "Not repeat numbers" will also be considered. Then the qualified patients will be numbered and will be numbered in control and intervention groups based on their number.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Voran-Schneider-Halper's quality of sleep questionnaire
2
Description
Anexiety
Timepoint
Night 1, 2 and 3 Use earplugs and eye mask
Method of measurement
Hospital anxiety and depression questionnaire
3
Description
Delirium
Timepoint
Night 1, 2 and 3 Use earplugs and eye mask
Method of measurement
NEECHAM Confusion Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The nurse will put an earplugs and eye mask on the patient at 22 o'clock and leave at 6 o'clock in the morning and put in the patient's closet. This is done for 3 consecutive nights.
Category
Prevention
2
Description
Control group: In the control group no special equipment will be used during the night.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Simin Sharafi
Street address
Ghaem Hospital., Ahmad abad Blv., Dr. Ali Shariati Square.