Effect of Sleep Hygiene Education on Sleep Quality of Patients with Heart Failure Hospitalized in Cardiac Care Units of Urmia Teaching Hospitals 2017-2018
Design
In this study, the units were selected by available method and then allocated randomly to two groups of intervention and control. The sample size in total was 70 persons in two groups of 35. The tools used in this study were the form of population profile Cognitive, weekly recording and the Pittsburgh Sleep Quality Index
Settings and conduct
Patients at the discharge stage from Seyyedol Shohada Medical Center of Urmia
Participants/Inclusion and exclusion criteria
In this study, patients with heart failure grade 2 and 3 in the age range of 30-70 years of age who have self-care ability and are available within three months are included in the study, and in the event of a patient's death or unwillingness to continue studying
Intervention groups
After one month of discharge, samples are taught through a booklet in the form of a sleeping public health. A pre-test test is performed and a weekly recording record sheet is provided to the samples. After one month, the post -test is done
Main outcome variables
Helping improve sleep quality in patients with heart failure and reducing insomnia from insomnia during the day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040760N1
Registration date:2018-09-03, 1397/06/12
Registration timing:retrospective
Last update:2018-09-03, 1397/06/12
Update count:0
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Vahideh sadat Majidi khanyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 6526
Email address
parastari_bep@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-05, 1396/11/16
Expected recruitment end date
2018-03-30, 1397/01/10
Actual recruitment start date
2018-02-05, 1396/11/16
Actual recruitment end date
2018-04-19, 1397/01/30
Trial completion date
empty
Scientific title
Effect of Sleep Hygiene Education on Sleep Quality of Patients with Heart Failure Hospitalized in Cardiac Care Units
Public title
"Effect of Sleep Hygiene Education on Sleep Quality of Patients with Heart Failure"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Heart Failure
Heart Failure class II، III
Having full vigilance
The ability to communicate effectively
Self-care ability
Availability and control within 3 months
Having no illnesses that disrupts the results of the study
Exclusion criteria:
Patient death
Unwillingness to continue reading by the patient
Not attending training sessions for more than one meeting
Failure to complete the weekly registration record for more than two days
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, units were selected by available method and divided into two groups of intervention and control by selecting two red and blue cards
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 Urmia University of Medical Sciences
Street address
Medical faculty of Orumi Medical University, Resalat Ave
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
IR.UMSU.REC.1396.348
Health conditions studied
1
Description of health condition studied
Sleep Hygiene Education
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep Quality
Timepoint
One month after the discharge, samples are trained from the hospital and one month after the intervention, the result of the training is measured
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After obtaining permission from the research council of the university and receiving the ethics code from the Ethics Committee, the researcher referred to the research environment and, after coordinating with the management of the specialized and specialized cardiology center of Seyyed Alshohada, patients with heart failure had entry conditions in the hospital Hospitalized and in the clearance stage; available in an accessible way, after giving explanations about the title of the research plan and its goals, will provide the company's consent form to the research and the demographic questionnaire to those who wish to participate in the project. After reaching the required amount of research samples, the researcher will arrange a meeting in person with all the individuals and after providing explanations on how to complete the weekly registration record, it will be provided to patients and will ask them to submit this sheet Complete for 4 weeks on a daily basis. After completing the weekly sleep schedule, the Pittsburgh Sleep Quality Index was completed by each patient to evaluate the sleep quality of the patients and the samples were randomly divided into intervention and control groups.The researcher in the intervention group, after one month of discharge from the hospital for 5 sessions of an hour, began to teach sleep hygiene based on the latest American National Sleep Association guidelines and authoritative sources in person, using educational slides and training manuals solo will be patient at home
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyyed Shahada Hospital
Full name of responsible person
Vahideh Sadat Majidi Khanyani
Street address
Seyyed Shahada Hospital
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4963
Email
majidi.v12@gmail.com
Web page address
https://www.umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rahim Baghaei
Street address
nursing school, Urmia University of Medical Sciences., Nazlou
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4963
Email
rbaghaei2001@yahoo.com
Web page address
https://www.umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Vahideh Sadat Majidi Khanyani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing School, Urmia University of Medical Sciences., Nazlou
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4963
Email
majidi.v12@gmail.com
Web page address
https://www.umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rahim Baghaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing School, Urmia University of Medical Sciences., Nazlou
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4963
Email
rbaghaei2001@yahoo.com
Web page address
https://www.umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Vahideh Sadat Majidi Khanyani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 19, Shahid Garezadnya Ave., Tehranpars
City
Tehran
Province
Tehran
Postal code
1136778117
Phone
+98 21 7787 6526
Email
majidi.v12@gmail.com
Web page address
https://www.umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available