Determining the effect of self-care interventions based on sleep hygiene, healthy nutrition and physical activity on sleep quality of patients after coronary artery bypass graft surgery.
Design
The experimental study was 160 people randomly divided into intervention and control groups. Then they were invited to participate in a question and answer session. Then, the written consent forms were completed by samples in both groups, and the personal information form and Pittsburgh sleep quality questionnaire were completed. Finally, the intervention group entered the intervention phase.
Settings and conduct
Samples were patients discharged after coronary artery bypass graft surgery in Seyyed Alshohada Hospital of Urmia in 1396. The intervention group attended a healthy sleep and nutrition education course for three months and appropriate physical activities that was held in the conference hall of the hospital and participated monthly in counseling sessions held by the researcher. The control group spent their normal lives during this period.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having at least reading and writing literacy;
Willingness to participation;
People aged 20-60 years;
Do not take hypnotic drugs;
Absence of debilitating diseases;
Exclusion criteria:
Dissatisfaction to continue participation;
Absence three or more sessions.
Intervention groups
Intervention group: They trained for self-care for sleep hygiene, healthy nutrition, and physical activity, by interventions including presenting films and education in sessions.
Control group: These people had their normal life during this period.
Main outcome variables
Sleep quality in patients after coronary artery bypass surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180515039677N1
Registration date:2018-06-30, 1397/04/09
Registration timing:retrospective
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Fahimeh Safarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3386 7998
Email address
safarzadehf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-01-20, 1396/10/30
Trial completion date
empty
Scientific title
The effectiveness of self-care interventions based on sleep health, healthy diet and physical activity on quality of sleep in post CABG patients
Public title
The effectiveness of self-care interventions on quality of sleep in post CABG patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least reading and writing skills, to fill in the questionnaire or answer questions
Willingness to participate;
People aged 20-60 years;
Do not use hypnotic drugs;
Failure to develop other debilitating diseases, such as diabetes, hypertension, MS, stroke
Exclusion criteria:
Unwillingness to continue participation any reason and at any stage of the research
three or more sessions absence
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
73
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this research was convenience based on inclusion criteria considering the number of samples,. At first, the file numbers of individuals were placed on cards of the same form and placed inside the pot. Then the cards were pulled out one by one to make up the number of research samples. Then samples were divided into two intervention and control groups by simple random allocation method.
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
West Azarbaijan, Urmia, Resalat Blvd, Jihad Street, Emergency Coyote, Research & Technology Dept.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.UMSU.REC.1396.234
Health conditions studied
1
Description of health condition studied
cardiovascular diseases
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Sleep quality score in Pittsburgh questionnaire after postoperative coronary artery bypass graft surgery
Timepoint
Measurement of sleep quality based on the Pittsburgh questionnaire, at the beginning of the intervention and 3 months after the implementation of self-care interventions including sleep health, healthy eating and physical activity.
Method of measurement
Pittsburgh questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, self-care education classes were held at Sayyid al-Shohada Hospital twice a week for 6 sessions each week (including 2 sessions on sleep hygiene, 2 sessions on healthy eating and 2 physical exercise sessions). Monthly counseling session was arranged by the researcher to solve self-care problems and respond to the questions of the subjects under study. During these sessions, checklist of diet, exercise, and sleep hygiene that was completed by research samples in the intervention group during the week was reviewed by the researcher and given feedback to the samples. Finally, the Pittsburgh questionnaire was completed again.
Category
Lifestyle
2
Description
Control group: At the first session, the written consent form was signed by the control group and a personal profile and Pittsburgh sleep quality questionnaire were completed. They were checked by the researcher, once a month, blood pressure and pulse. Last session, again, the sleep quality questionnaire was completed by him.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Seyyed Al- Shohada Hospital
Full name of responsible person
Fahimeh Safarzadeh
Street address
Seyed Shahada Hospital, Sefid Shahrivar St.
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
fahimeh.safarzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj
Street address
Urmia Blvd. Ultralum Emergency Department, Department of Research and Technology
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
fahimeh.safarzadeh@yahoo.com
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
Tabriz University of Medical Sciences
Full name of responsible person
Fahimeh Safarzadeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.49,Sarv Ave., Bghcheban St., Elgoli Town
City
Tabriz
Province
East Azarbaijan
Postal code
5167958844
Phone
+98 41 3386 7998
Fax
Email
fahimeh.Safarzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fahimeh Safarzadeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.49,Sarv Ave., Bghcheban St., Elgoli Town
City
Tabriz
Province
East Azarbaijan
Postal code
5167958844
Phone
+98 41 3386 7998
Fax
Email
fahimeh.Safarzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fahimeh Safarzadeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.49,Sarv Ave., Bghcheban St., Elgoli Town
City
Tabriz
Province
East Azarbaijan
Postal code
5167958844
Phone
+98 41 3386 7998
Fax
Email
fahimeh.Safarzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to confidentiality of personal data data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Effect of Self-care Interventions on Sleep Hygiene, Healthy Nutrition and Physical Activity on Sleep Quality of Patients after Coronary Artery Disease
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
All people working in academic and scientific institutions and those working in medical sciences
Under which criteria data/document could be used
For clinical use to improve dormancy of heart patients
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
Six months after printing results, you can visit my e-mail