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The effect of cardiac rehabilitation on sexual function and coping with stress in CABG patients

Protocol summary

Summary
Objective: The aim of this study was to investigate the effect of cardiac rehabilitation on sexual function and coping with stress in CABG patients. Methods: This is a clinical trial study. Inclusion criteria: Male patients undergoing open heart surgery (coronary artery bypass graft). Age of 18 to 75 - Married - Exclusion criteria: 1) Immigration or absence of any reason 2) Patients with muscle weakness and skeletal problems. Twenty-six patients were randomly assigned(Random number table) and double blind(Patient and researcher assistance) into two intervention and control groups. Then, the general information questionnaire, the International Sexual Function Index (IIEF-5), Andler & Parker Stress Coping Strategies, by Patients And the researcher will be completed before and after the intervention in the control and intervention group. Subsequently, the patients in the control group are placed under the current cardiac rehabilitation program, which includes nutrition counseling and aerobic exercise exercises using treadmills and fixed bikes three times a week for 30 minutes. But in the intervention group, in addition to the above, the Kegel Exercise [Includes long and short cycle exercises. Each type of exercise is performed daily, with an equivalent time of 10 minutes and three times a day] performed by the researcher In fact, in this study, the rehabilitation program is being implemented as moderated. As mentioned, the main outcome variables that will be studied in this study are sexual performance and coping with stress in CABG patients, using the International Sexual Function Index (IIEF-5) and Andler & Parker Stress Coping Strategies Questionnaire will be.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082324080N12
Registration date: 2017-09-05, 1396/06/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-05, 1396/06/14
Registrant information
Name
Mohammad Gholami
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 509 1279
Email address
gholami.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Campus Kamalvand, Vice Chancellor for Research, Lorestan University of Medical Sciences
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2017-05-05, 1396/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cardiac rehabilitation on sexual function and coping with stress in CABG patients
Public title
The effect of cardiac rehabilitation on sexual function and coping with stress in CABG patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Male patients undergoing open heart surgery (coronary artery bypass graft). Age of 18 to 75 - Married - No history of psychiatric illness and diabetes - Introduced by a surgeon to perform rehabilitation - Resident of Kermanshah - No history of sexual dysfunction before surgery - No history of using drugs affecting sexual activity - No history Peripheral vascular disease Exclusion criteria: 1) Immigration or absence of any reason 2) Unwillingness to continue to participate in research 3) Patients with less than 30 percent EF 4) Patients with muscle weakness and skeletal problems
Age
From 18 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Lorestan University of Medical Sciences
Street address
Nursing and Midwifery Department, Campus Kamalvand, Lorestan University of Medical Sciences
City
Khorramabad
Postal code
6814993165
Approval date
2016-06-17, 1395/03/28
Ethics committee reference number
Lums.REC.1395.120

Health conditions studied

1

Description of health condition studied
Sexual function and coping with stress in CABG patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual function and coping with stress
Timepoint
Before and after intervention
Method of measurement
International Sexual Function Index (5EIF) and Andler & Parker Stress Coping Strategies Questionnaire

Secondary outcomes

1

Description
Sexual function and coping with stress
Timepoint
Before and after intervention
Method of measurement
International Sexual Function Index (IIEF-5) Questionnaire and Andler & Parker Stress Coping Strategies

Intervention groups

1

Description
In intervention group, in the first or second session of rehabilitation (before intervention), personal information questionnaires, the Andler & Parker Stress Coping Strategies Questionnaire and the International Index of Erectile Function (IIEF-5) were completed. At the beginning of the cardiac rehabilitation program, the health status and patient visit was performed by a specialist in exercise medicine and diet, then a common cardiac rehabilitation program was performed in 26 sessions (pairs, three times a week). During the physical activity phase, the patients slowly runse and exercise in the warm-up phase for 10 minutes, then 20-30 minutes of dynamic exercise using treadmill and fixed bicycle, and the exercise session with 10 minutes of cooling (slow walk in the gym) It ends. In the nutrition dimension, nutrition education, nutrition, oils, and its relation to cardiovascular disease, food pyramid and ways to use it, control and ways to reach the weight of the idea are provided by the nutritionist. In addition to common cardiac rehabilitation, after aerobic exercise to help resolve the sexual dysfunction of patients, they also carry pelvic muscle building exercises (Kegel Exercise). Training on how to perform the Kegel exercise by researcher and researcher help is Individual and small groups are trained in a quiet place in the rehabilitation hall verbally, face-to-face, and in the language of the patient's speech. (In this exercise, the patient first recognizes the ptobuccosis muscle, To find this muscle, it is necessary to stop urine flow while urinating. This requires that the muscle contraction in the pelvic floor and Patient can sense the pelvic floor by touching the muscle and contract it, then perform the Kegel exercise as follows: Long cycle exercise 1) Shrinks the pubococcygeus muscle and maintains this contraction for 10 seconds. 2) Muscle Exit from shrinkage and relax for 10 seconds. 3) Repeat this cycle 15 times, and after that it relaxes 1 minute of muscle and performs short cycle exercises. Short Cycle Exercise 1: The muscle shrinks the pc for one second and relaxes for one second. 2) These one-minute cycles repeat the contraction and expansion 10 times. In doing the exercises, you normally breathe and avoid abdominal muscle contraction. Considering the proper relaxation of the pelvic floor muscles, along with their proper shrinkage, attention is drawn to regular shrinkage cycles. Both types of exercise are performed daily, with an equivalent time of 10 minutes and three times a day). And in psychology, psychological and social factors of stress and ways to cope with stress) in the problem-oriented coping style, one focuses on the problem and tries to solve it. First defines the problem and seeks various solutions. Emotional response focuses on emotional control and emotional responses. Dealing with physical measures such as exercising or taking medication, getting rid of your anger over others, crying, getting angry, and shouting is a way of coping with this method. In an avoidant coping style, one tries to cognitive change and distance from reality, avoiding the problem, escapes and avoids it and receives emotional support.) The ways of achieving peace are among the classes taught by The researcher is trained. In fact, a modified rehabilitation program was implemented in this study. In the final intervention (after intervention), personal information questionnaires, the Andler & Parker Stress Coping Strategies Questionnaire and the International Index of Erectile Function (IIEF-5) were completed again.
Category
Rehabilitation

2

Description
In the control group at the beginning of the rehabilitation program, personal information questionnaires, the Andler & Parker Stress Coping Strategies Questionnaire and the International Index of Erectile Function (IIEF-5) were completed . then a common cardiac rehabilitation program was performed in 26 sessions (pairs, three times a week). During the physical activity phase, the patients slowly runse and exercise in the warm-up phase for 10 minutes, then 20-30 minutes of dynamic exercise using treadmill and fixed bicycle, and the exercise session with 10 minutes of cooling (slow walk in the gym) It ends. In the nutrition dimension, nutrition education, nutrition, oils, and its relation to cardiovascular disease, food pyramid and ways to use it, control and ways to reach the weight of the idea are provided by the nutritionist. In the final session of Rehabilitation, personal information questionnaires, the Andler & Parker Stress Coping Strategies Questionnaire and the International Index of Erectile Function (IIEF-5) were completed again.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
peyman kaikhoro doulatyari
Street address
Shahid Beheshti Blvd.
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Lorestan University of Medical Sciences
Full name of responsible person
Peyman Kaikhosro Doulatyari
Street address
Vice Chancellor for Research and Technology، Campus Kamalvand, Lorestan University of Medical Sciences
City
Khorramabad
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 Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
peyman kaikhosro doulatyari
Position
Masters student
Other areas of specialty/work
Street address
Nursing and Midwifery Department, Campus Kamalvand, Lorestan University of Medical Sciences
City
Khorramabad
Postal code
6813833946
Phone
+33 120172
Fax
Email
p.k.doulatyari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Mohammad Gholami
Position
Phd
Other areas of specialty/work
Street address
Nursing and Midwifery Department, Campus Kamalvand, Lorestan University of Medical Sciences
City
Khorramabad
Postal code
Phone
+98 66 3312 0140
Fax
Email
mohammad13565@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
peyman kaikhosro doulatyari
Position
Masters student
Other areas of specialty/work
Street address
Nursing and Midwifery Department, Campus Kamalvand, Lorestan University of Medical Sciences
City
Khorramabad
Postal code
Phone
+98 66 3312 0172
Fax
Email
p.k.doulatyari@gmail.com
Web page address

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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