Sleep disturbance depends on a couple of factors such as noise, light and dark cycle disorder in cardiac care unit(CCU) that can lead to acute coronary syndrome . One of the important factor is environment. Sleep can be improved by reducing physical milieu. Although many studies have been working on sleep disorder there is little focus on removing bothering environmental features. This study was designed to compare the effects of simple and low cost devices such as eye mask and earplugs with each other on reducing the environmental factors and improving sleep in CCU patients. This study is a randomized clinical trial conducted in Afshar Hospital of yazd in 2014.90 Patients were randomly divided into three groups: eye mask, earplugs and both eye mask and earplugs users. VAS scale At the beginning and end of stay in icu will be completed by the researcher
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407127875N4
Registration date:2015-02-16, 1393/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-16, 1393/11/27
Registrant information
Name
Hossein Rahmani
Name of organization / entity
Ahvaz jondishapour university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1444 2865
Email address
rahmani.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahid Sadughi University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eye masks and earplugs on sleep quality of patients with myocardial infarction CCU
Public title
The effect Ofuse of eye masks and earplugs on sleep quality of patients with myocardial infarctionin ccu
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Minimum age 25 years; Alert and aware of the time and place; Able to respond scale, EF up to 40% .
Exclusion criteria: Having chronic sleep disorders; Get sleep medications and intravenous narcotics and general anesthesia in 12 hours before the study; Hearing and vision problems.
Age
From 25 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, safaie, yazd
City
yazd
Postal code
Approval date
2014-03-18, 1392/12/27
Ethics committee reference number
17/1/257636/P
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified
Primary outcomes
1
Description
sleep quality
Timepoint
At the beginning and end of stay in CCU
Method of measurement
verbal analoge scale
Secondary outcomes
empty
Intervention groups
1
Description
Using earplugs and eye masks
Category
Prevention
2
Description
Using eye masks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Afshar Hospital
Full name of responsible person
Street address
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Saduqi University of Medical Sciences
Full name of responsible person
vice chancellor for research of Shahid Saduqi University of Medical Sciences
Street address
Shahid Saduqi University of Medical Sciences , safaieh
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Saduqi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Saduqi University of Medical Sciences
Full name of responsible person
zahra fahim raouf
Position
master of science
Other areas of specialty/work
Street address
Shahid Saduqi University of Medical Sciences
City
yazd
Postal code
Phone
+98 913 354 0724
Fax
Email
sara.fraouf@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Saduqi University of Medical Sciences
Full name of responsible person
khadije dehghani
Position
master of science
Other areas of specialty/work
Street address
Shahid Saduqi University of Medical Sciences
City
yazd
Postal code
Phone
+98 913 153 5531
Fax
Email
khadi20y@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Saduqi University of Medical Sciences
Full name of responsible person
zahra fahim raouf
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
sara.fraouf@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)