Sleep disturbance is 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 and worsen the patients' condition. One of these important factors is environmental. 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 Imam Khomeini Hospital of Jiroft in 2011. Patients were randomly divided into three groups: eye mask, earplugs and both eye mask and earplugs users. Crossover method was used; so that half of the patients in each group were assumed control for themselves the first night and the other half on the second night. The day after VSH-scale was filled at 9 am by participants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205139731N1
Registration date:2012-11-25, 1391/09/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-25, 1391/09/05
Registrant information
Name
Fateme Mashayekhi
Name of organization / entity
Jiroft University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 8221 7579
Email address
f.mashayekhi@jmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences, Neuroscience Research Center
Expected recruitment start date
2011-08-11, 1390/05/20
Expected recruitment end date
2011-12-19, 1390/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of using earplugs and eye masks on sleep quality in coronary care unit (CCU)
Public title
The effects of using earplugs and eye masks on sleep quality in coronary care unit (CCU)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Minimum age 18 years; Alert and aware of the time and place; Able to respond VSH-scale (Sleep quality). 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 18 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
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of vice chancellor for research, Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad street
City
Kerman
Postal code
Approval date
2011-10-19, 1390/07/27
Ethics committee reference number
k/90/8
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Sleep disorder
Timepoint
The night before the intervention and after the intervention (9 am)
Method of measurement
VSH-scale
Secondary outcomes
1
Description
Sleep disorders
Timepoint
The night before the intervention and after the intervention (9 Am)
Method of measurement
VSH-scale
Intervention groups
1
Description
Using eye masks
Category
Prevention
2
Description
Using earplugs
Category
Prevention
3
Description
Using earplugs and eye masks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac care unit (CCU), Imam Khomeini Hospital of Jiroft
Full name of responsible person
Fateme Mashayekhi
Street address
Jiroft University of Medical Sciences
City
Jiroft
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Dr. Malekpour Afshar
Street address
Jahad street
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman 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
Jiroft University of Medical Sciences
Full name of responsible person
Fateme Mashayekhi
Position
MSc in Nursing, Critical Care
Other areas of specialty/work
Street address
Jiroft University of Medical Sciences
City
Jiroft
Postal code
Phone
+98 34 8221 7579
Fax
Email
fatememashayekhi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSc Nursing, Lecturer, Faculty member of Kerman University of Medical Sciences
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kerman University of Medical Sciences
City
Kerman
Postal code
Phone
+98 34 1320 5220
Fax
Email
marab@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jiroft University of Medical Sciences
Full name of responsible person
Fateme Mashayekhi
Position
MSc in Nursing, Critical Care, Faculty member of Jiroft University of Medical Sciences
Other areas of specialty/work
Street address
Jiroft University of Medical Sciences
City
Jiroft
Postal code
Phone
+98 34 88084
Fax
Email
fatememashayekhi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)