The effect of phase I cardiac rehabilitation on perception of disease and health literacy of patients undergoing coronary artery bypass grafting was evaluated.
Design
This study is a pre-test and two-group clinical trial; the participants were 60 (30 in the control group and 30 in the intervention group). Randomization is done by block method
Settings and conduct
The first phase of cardiac rehabilitation was performed preoperatively, intraoperatively (two days postoperatively) and postoperatively (five days postoperatively) for patients undergoing coronary artery bypass grafting.Its effect onillness perception of health literacy in control and intervention groups was performed in Shahid Rajaee hospital of Alborzn cardiac surgery and internal coronary ward.
Participants/Inclusion and exclusion criteria
All patients undergo open heart surgery who only perform coronary artery bypass grafting.
Intervention groups
Implementation of the first phase of cardiac rehabilitation for intervention group and routine care for control group
Main outcome variables
illness perception;Health literacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190805044442N1
Registration date:2020-02-01, 1398/11/12
Registration timing:retrospective
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
fahimeh reyhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3432 9866
Email address
fahima.reyhani8888@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-23, 1396/09/02
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-11-23, 1396/09/02
Actual recruitment end date
2018-02-20, 1396/12/01
Trial completion date
2018-03-11, 1396/12/20
Scientific title
The Effect of First phase of cardiac Rehabilitation on Illnes Perception and Health Literacy of patients under coronary artery bypass graft of
Public title
The effect of the first phase of cardiac rehabilitation in cardiac surgery patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients waiting for coronary artery bypass graft surgery; at least two days have passed since their angography.
Consent to participate in the research
No neurovascular diseases (according to the patient's own medical records)
First time experience coronary artery bypass graft surgery
Be vigilant (aware of location, time and person).
Surgery in the operating room has undergone a routine procedure (coronary artery bypass grafting only)
There are no postoperative complications such as extensive drainage, pneumothorax, tamponade, dangerous arrhythmia, and so on.
Exclusion criteria:
In case of death of sample
During the study, the patient may experience acute complications from surgery.
If the condition worsens (re-entry to the operating room)
• In case of incomplete completion of the questionnaire of dissatisfaction with continuing to participate in the research at each stage
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block random method was used to select the subjects in the control and intervention groups. According to the sample size, 30 patients were in the control group and 30 in the intervention group.
Questionnaires were completed by people who were eligible for the study. Then they were randomly assigned into intervention and control groups. Sample allocation was performed in both groups randomly. And after the number of people in each block reached five. Sampling from another group was repeated. Up to 30 in each group. Six blocks of five were created in each group. A total of 68 patients were included in the study
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 for Research of University of Social Welfare and Rehabilitation Sciences
Street address
Evin, Student Boulevard, Koodakyar Dead End
City
tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۷۱
Approval date
2017-07-04, 1396/04/13
Ethics committee reference number
IR.USWR.REC.1396.138
Health conditions studied
1
Description of health condition studied
Cardiac rehabilitation
ICD-10 code
Z50.0
ICD-10 code description
Cardiac rehabilitation
Primary outcomes
1
Description
Comparison illness perception score between intervention and control groups
Timepoint
Measurement of illness perception score before intervention and one month after hospital discharge
Method of measurement
Illness Perception Questionnaire
2
Description
Measure health literacy score before intervention and one month after hospital discharge
Timepoint
Measure health literacy score before intervention and one month after hospital discharge
Method of measurement
Health Literacy for Iranian Adults questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first phase of cardiac rehabilitation was performed in 4 sessions of 30 minutes in a multi-disciplinary form for patients in the intervention group .Including training by a rehabilitation nurse to help shape the patient's understanding of coronary artery bypass grafting, counseling by a nutrition expert, preoperative exercise training, and post-surgery coronary artery bypass graft physicians, as well as patient group education with family members After surgery, a rehab nurse was done.The health literacy and perception of the disease were analyzed in two steps before surgery and one month after the operation using SPSSv22 software, Chi-square, t-student and analysis of co variance and variance were analyzed.
Category
Rehabilitation
2
Description
Control group: Control group:The intervention in the control group only included routine hospital training .One month after the operation, they received a pamphlet of training that was provided by the intervention group in response to a questionnaire on illness and health literacy.Perceived status of disease and health literacy, in two stages before surgery and one month after operation by SPSSv22 software, using chi-square, independent and paired t-test and analysis of covariance and variance. Was analyzed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Fahimeh Reyhani
Street address
Al Mahdi Street Shahid Beheshti Street
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3455 2003
Email
rajaei@abzums.ac.ir
Web page address
https://rajaei.abzums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Reza Khankeh
Street address
Koodakyar Street, Student Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
pr@uswr.ac.ir
Web page address
http://www.uswr.ac.ir
Grant name
Not used.
Grant code / Reference number
استفاده نشده است
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
20
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Fahimeh Reyhani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 39.2, Fourth Floor Unit 12,West-Ghalam Ave, 17 Shahin Villa St, Baghestan
City
Karaj
Province
Alborz
Postal code
3193976917
Phone
+98 26 3432 9866
Fax
Email
fahima.reyhani8888@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fahimeh Reyhani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 39.2, Fourth Floor Unit 12., West-Ghalam Ave., 17 Shahin Villa St ., Baghestan
City
Karaj
Province
Alborz
Postal code
3193976917
Phone
+98 26 3432 9866
Fax
Email
fahima.reyhani8888@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fahimeh Reyhani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 39.2, Fourth Floor Unit 12., West-Ghalam Ave., 17 Shahin Villa St ., Baghestan
City
Karaj
Province
Alborz
Postal code
31939766917
Phone
+98 26 3432 9866
Fax
Email
fahima.reyhani8888@gmail.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
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable people.
When the data will become available and for how long
"Start of access period 6 months after printing results"
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
I will decide whether to use the data or documentation provided by me in relation to the type of study and the conditions of its use.I will agree with the caller at the same time.