Determining the effect of adjustment of environmental factors on sleep quality in patients hospitalized in Coronary Care Unit
Design
Randomized clinical trial with control group, parallel groups, one-blinded.
Settings and conduct
The present study will be conducted at Modarres Hospital on patients hospitalized in Coronary Care Unit. The analyzer will not know how to place the samples in the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The willingness to participate in the study
Passes at least 6 days after hospitalization
Don't use of somnifacient drugs
18 to 65 years old
Exlusion criteria:
Unwilling to participate in the study
History of sleep disorder
Intervention groups
For intervention group, measures are taken to moderate environmental factors, including downsizing of telephone calls, alarms of devices, shutdown of all additional lights during the night, and use of low light during the daytime.
Control group samples are in normal condition and receive standard care.
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161210031328N8
Registration date:2018-07-08, 1397/04/17
Registration timing:registered_while_recruiting
Last update:2018-07-08, 1397/04/17
Update count:0
Registration date
2018-07-08, 1397/04/17
Registrant information
Name
Mahbobeh Sajadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
m.sajadi@arakmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
1639-01-14, 1017/10/24
Expected recruitment end date
2639-05-24, 2018/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adjustment of environmental factors on sleep quality of patients admitted to the cardiology unit of Shahid Modarres Hospital of Saveh
Public title
Adjustment of environmental factors on the quality of sleep in patients admitted to the Cardiac Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The willingness to collaborate in the study
Admission for at least 6 days
Do not use hypnotic drugs
Having a range of 17 to 64 years old
Not having a specific disease, such as hepatitis
Exclusion criteria:
Surrender patient
sleep disorder
Transferring the patient to other parts
Age
From 17 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
groups over successive but equal intervals.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer will not know how to place the samples in the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Samples were randomly assigned to two intervention and control groups using randomized block assignment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشکده علوم پزشکی ساوه
Street address
Saveh University of Medical Sciences, Madar Sq., Shariati St.
City
Saveh
Province
Markazi
Postal code
3919676651
Approval date
2638-10-17, 2017/07/25
Ethics committee reference number
IR.SVEHUMS.REC1396.13
Health conditions studied
1
Description of health condition studied
Sleep quality
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality
Timepoint
Before the study and six days after the first day of hospitalization
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: from the third day after the hospitalization, adjustments to the environmental factors (including reduction of light and surplus voices) are performed consecutively for three days.
Category
Lifestyle
2
Description
Control group: from the third day after hospitalization without any changes in the physical conditions of the unit and without any additional work until the 6 days will be monitored.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
Elham Farhadi
Street address
Shahid Modares Hospital, Modarres Sq.
City
Saveh
Province
Markazi
Postal code
3915953983
Phone
+98 86 4222 3026
Email
info@savehums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Hamid Reza Baradaran
Street address
Saveh University of Medical Sciences, Madar Sq., Shariati St.
City
Saveh
Province
Markazi
Postal code
3919676651
Phone
+98 86 4234 3395
Email
baradaran98@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Saveh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Neda Fayazi
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Saveh University of Medical Sciences, Madar Sq., Shariati St.
City
Saveh
Province
Markazi
Postal code
3919676651
Phone
+98 86 4223 3395
Email
nedafayazi10@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Neda Fayazi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Saveh University of Medical Sciences, Madar Sq., Shariati St.
City
Saveh
Province
Markazi
Postal code
3919676651
Phone
+98 86 4234 3395
Email
nedafayazi10@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Neda Fayazi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Saveh University of Medical Sciences, Madar Sq., Shariati St.
City
Saveh
Province
Markazi
Postal code
3919676651
Phone
+98 86 4234 3395
Email
nedafayazi10@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared after unidentifiable of people.
When the data will become available and for how long
The beginning of the access period is 12 months after the results are published.
To whom data/document is available
For all researchers
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
nedafayazi10@yahoo.com
Neda Fayazi
What processes are involved for a request to access data/document
After receiving the email from the requester, the information will be sent within 2 to 3 business days.