Protocol summary

Summary
This study is an open uncontrolled trial type. The aim of this study is to determine the effectiveness of an educational intervention based on PRECEDE model in improving sleep quality of patients after coronary artery bypass surgery. First, 100 patients refferal to cardiac rehabilitation clinic of Tehran Heart Center having inclusion criteria will be selected and randomly assigned into intervention and control group (50 patients in each group). Selection criteria in the present study is: the patient’s agreement to participate, patients of two genders between 40-80 years of age, only CABG treatment (not combined with valve replacement surgery), current complaint of poor SQ (score>5 of SQ scale), no history of chronic insomnia for at least one year before surgery, body mass index (BMI) ≤35 kg/m2, no indication of receiving treatments for depression and anxiety and no history of a major and serious comorbidity except for the risk factors of arthrosclerosis such as diabetic. During the study period, patients who receive sleeping medications were excluded from the study. Then, pre-test to measure PRECEDE model items (including predisposing, enabling and reinforcing factors regarding sleep) for both groups will be done. After performing pre-test and analyzing the data, educational intervention will be designed according to the pre-test results. Then, educational intervention will be performed for the intervention group. It is considered that the two groups received the provided usual interventions by cardiac rehabilitation clinic. Finally, the two groups are followed 1 month after the intervention and the effect of intervention in sleep quality of patients in the two groups will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305047132N5
Registration date: 2013-12-21, 1392/09/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-21, 1392/09/30
Registrant information
Name
Tahereh Dehdari
Name of organization / entity
Iran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 2188779118263
Email address
t-dehdari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences and Health Services
Expected recruitment start date
2013-04-06, 1392/01/17
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational intervntion besed on PRECEDE model in improving sleep quality of patients after coronary artery bypass surgery
Public title
Design and evaluation of educational intervntion besed on PRECEDE model in improving sleep quality of patients after coronary artery bypass surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The patient’s agreement to participate, patients of two genders between 40-80 years of age, only CABG treatment (not combined with valve replacement surgery), current complaint of poor SQ (score>5 of SQ scale), no history of chronic insomnia for at least one year before surgery, body mass index (BMI) ≤35 kg/m2, no indication of receiving treatments for depression and anxiety and no history of a major and serious comorbidity except for the risk factors of arthrosclerosis such as diabetic. exclusion criteria: patients who receive sleeping medications during the study.
Age
From 35 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences and Health Services
Street address
Hashid Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-12-11, 1392/09/20
Ethics committee reference number
23597

Health conditions studied

1

Description of health condition studied
Sleep disorders
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified

Primary outcomes

1

Description
Improving sleep quality
Timepoint
One month after intervention
Method of measurement
Quessionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Performing educational intervention .The educational intervention content and educational planning will be designed based on pre-test results.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiac Reabilitation Clinic of Tehran Heart Center
Full name of responsible person
Dr. Saeid sadeghian
Street address
Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Iran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Abbas Motevalian
Street address
Shahid Hemmat Highway, Iran University of Medical Sciences
City
Tehran
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 of Iran University of Medical Sciences and Health Services
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
Iran University of Medical Sciences and Health Services
Full name of responsible person
Tahereh Dehdari
Position
Ph.D
Other areas of specialty/work
Street address
Alvand avenue, Argentine square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
dehdarit@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences and Health Services
Full name of responsible person
Tahereh Dehdari
Position
Ph.D
Other areas of specialty/work
Street address
Alvand avenue, Argentine square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
dehdarit@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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