The aim of this study is to evaluate the effect of cardiac rehabilitation phase 2 on hope and sexual satisfaction in patients after coronary artery bypass graft surgery. Inclusion criteria: patients who have undergone cardiac surgery at least one month ago and have been referred to Al Zahra hospital Cardiac Rehabilitation ward for Cardiac Rehabilitation; people who are educable. Exclusion criteria: the patient's unwillingness to cooperate in research; having life-threatening conditions such as arrhythmias, heart block, metabolic disorders, etc. The total sample size is 104 and patients will be allocated into two groups using a random number table (each n = 52). Intervention group will receive 6 training sessions in companion with 20 cardiac rehabilitation sessions and the control group will receive only 20 cardiac rehabilitation sessions. Pretest and post test will be done for both groups using Miller hopes questionnaire and Larson sexual satisfaction questionnaire. After the completion of 20 cardiac rehabilitation sessions, post test for will be performed for both groups. The primary outcomes are hope and sexual satisfaction.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017041633344N2
Registration date:2017-06-03, 1396/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-03, 1396/03/13
Registrant information
Name
Afsoon Tofigh
Name of organization / entity
Shiraz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4255
Email address
stud2298207593@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shiraz University of Medical Sciences
Expected recruitment start date
2017-03-12, 1395/12/22
Expected recruitment end date
2018-05-12, 1397/02/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of phase II cardiac rehabilitation on
sexual satisfaction and hope in patients undergoing coronary artery bypass graft surgery
Public title
The effect of cardiac rehabilitation on heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who have undergone cardiac surgery at least one month ago; being educable; having the ability to understand, speak, read and write in Persian. Exclusion criteria: uncontrolled blood pressure (>180/100); obvious aortic narrowing (diameter less than 1cm); arrhythmias; uncontrolled 3rd degree ventricular or atrial block of without pacemaker; decompensated heart failure; thyroiditis; hypokalemia; hyperkalemia; uncontrolled diabetes; fever; acute systemic diseases; severe orthopedic problems; musculoskeletal problems preventing doing activities; chronic mental disorders; cognitive impairment; vision problems and severe hearing problems; known neurological problems such as Parkinson, multiple sclerosis and ....
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Namazi Square
City
Shiraz
Postal code
71345-1978
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.SUMS.REC.1395.204
Health conditions studied
1
Description of health condition studied
Patients after coronary artery bypass graft surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
hope
Timepoint
Before and after 20 sessions of cardiac rehabilitation
Method of measurement
questionnaire
2
Description
sexual satisfaction
Timepoint
Before and after 20 sessions of cardiac rehabilitation
Method of measurement
questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
In Intervention group sports programs and 6 sessions of educational programs will be conducted. Each training session will last approximately 15-20 minutes. The training will be done before exercise. After patient’s discharge training in various fields including heart anatomy, heart diseases and treatments, diet, medications, exercise, activity and the hope and optimism and pain management will be provided to patients. In fact, educational (training) program will be held through session 1 to session 6. In subsequent sessions, follow-up with regard to the provided training sessions, patient’s need to take consultation and questions’ answers will be provided to the patients.
Category
Rehabilitation
2
Description
In control group, patients will not receive training and only rehabilitation sports will be done. At the end of 20 sessions patients in this group will be provided with the training manual given to the patients in intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital in Shiraz
Full name of responsible person
Afsoon Tofigh
Street address
Al Zahra Hospital, Sibooyeh boulevard, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shiraz University of Medical Sciences
Full name of responsible person
Dr-Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Namazi square, Shiraz
City
Shiraz
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,Shiraz University of Medical Sciences
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
Shiraz University of Medical Siences
Full name of responsible person
Afsoon Tofugh
Position
Msc student in adult nursing
Other areas of specialty/work
Street address
Hazrat Fatemeh college of nursing & midwifery, Namazi square, Shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
+98 64 74254
Email
Afsoon2008t@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Siences
Full name of responsible person
Dr Mahnaz Rakhshan
Position
PhD in nursing
Other areas of specialty/work
Street address
Hazrat Fetemeh College of Nursing & Midwifery, Namazi square, Shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
+98 64 74252
Email
mzrakhshan@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university of Medical Siencel
Full name of responsible person
Afsoon Tofigh
Position
CCN (student)
Other areas of specialty/work
Street address
Hazrat Fetemeh College of Nursing & Midwifery, Namazi square, Shiraz Shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
+98 64 74252
Email
Afsoon2008t@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)