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The Effect of Sexual Rehabilitation Program on Anxiety, Stress, Depression and Sexual Function in Men With Coronary Artery Disease

Protocol summary

Summary
This Research Aims to Investigate the Effect of the Sexual Rehabilitation Program on Anxiety, Stress Depression and Sexual Operation of Men Suffering from Coronary Artery Disorder The Research Method: The Present Research is a Clinical Trials Study. And its Society Includes Men Suffering from Coronary Artery Disorder Who are Impatient in Police Hospital of Kerman, CCU Unit, Since March 2016 until April 2017.The Sample Volume has been Estimated 40 Men, Considering The Possibility of Effusion of Some Samples Using the Formula of 36 Men in Each Group. The Research Sample Includes 80 Men Suffering From Coronary Artery Disorder Grouped Randomly in Two Groups of Control an intervention in Terms of Weak Even and Odd Days. The Observation Group Patients Receive Only the Routine Cares, and The Patients of Test Group Receive Face to Face Instruction, Educational Pamphlets and Sound CDs About Sexual Rehabilitation When Discharged from Hospital. Criteria for Being Included in The Study: Married Patients, Age of 18-65, not Suffering from Psychological Disorders, and Diseases Affecting Function such as Urinary System, Nervous System and Skeletal Diseases, Men having Literacy Skill, Filling the Form of Agreement for Participating in The Study Criteria for Excluding from The Study: Leaving the Study Process and Disinclination to Cooperation, and Occurring any Unpleasant Events During The Research

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111224919N6
Registration date: 2017-07-12, 1396/04/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-12, 1396/04/21
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Kerman University of Medical Sciences
Expected recruitment start date
2017-04-19, 1396/01/30
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Sexual Rehabilitation Program on Anxiety, Stress, Depression and Sexual Function in Men With Coronary Artery Disease
Public title
The Effect of Sexual Rehabilitation program on Anxiety, Stress,Depression and Sexual Function in Heart Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Married Patients; Age of 18-65; not Suffering from Psychological Disorders, and Diseases Affecting Function such as Urinary System; Nervous System and Skeletal Diseases; Men having Literacy Skill; Filling the Form of Agreement for Participating in The Study Exclusion criteria: Leaving the Study Process and Disinclination to Cooperation; Occuring any Unpleasant Events During The Research
Age
From 18 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe of Kerman University of Medical Sciences
Street address
Pardis oloompezeshki .Haft baghe alavi
City
kerman.
Postal code
Approval date
2016-08-20, 1395/05/30
Ethics committee reference number
ir.kmu.rec.1395.235

Health conditions studied

1

Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Stress
Timepoint
Before The Intervention, One Month After The Iintervention
Method of measurement
Questionnaire Dass21

2

Description
Anxiety
Timepoint
Before The Intervention, One Month After The Intervention
Method of measurement
dass 21

3

Description
Depression
Timepoint
Before TheIintervention, One Month After The Intervention.
Method of measurement
dass 21

4

Description
Sexual Function
Timepoint
Before The Intervention, One Month AfterThe Intervention
Method of measurement
International Erectile Function Questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
The Observation Group Patients Receive Only the Routine Cares.
Category
Rehabilitation

2

Description
The Patients of Test Group Receive Face to Face Instruction, Educational Pamphlets and 20 minutes Sound CD s Includes Pelvic Extensore Muscle Exercise Training When Discharged from Hospital.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Sydalshhda
Full name of responsible person
Fatemeh Rafati
Street address
Astqlal Street- 10 Astqlal
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti Ph.D
Street address
Center of Clinical Research
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences؛ Pardis oloompezeshki, Haft bagHe
Full name of responsible person
Fatemeh.Rafati
Position
Master student
Other areas of specialty/work
Street address
Villa complex crossroads of Golestan
City
Kerman
Postal code
Phone
+98 34 3132 5000
Fax
Email
Fatemeh.rafati3179@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgary Ph.D
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Pardis oloompezeshki, Haft bagHe
City
Kerman
Postal code
Phone
+98 34 3132 5000
Fax
Email
B_tirgari@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Rafati
Position
Master student
Other areas of specialty/work
Street address
Villa Complex Crossroads of Golestan
City
Kerman
Postal code
Phone
+98 32473179
Fax
Email
Fatemeh.rafati3179.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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