This study is designed to determine the individual sexual consultation effect on psycho social condition of post MI patients. This study is a single blinded RCT research that samples will be random allocated to control and intervention groups. Inclusion criteria are to be married,suffering MI and to have sexual activity before MI. Exclusion criteria are erection disorder and urinary tract disease. Sample size is determined according to similar studies which is 25 patients per group. Intervention in this study is individual consultation for intervention group for 20 minutes in four days after admission in hospital. Output of this study will be psycho social condition (anxiety, depression, quality of life and sexual satisfaction) of the MI patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508246801N3
Registration date:2015-11-10, 1394/08/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-10, 1394/08/19
Registrant information
Name
Hadi Hassankhani
Name of organization / entity
Tabriz university of medical sciences and health services
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0364
Email address
hassankhanih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences - research administration
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Individual Sexual Councelling on Psychsocial Status of Post MI Patients- Single-Blinded Randomised Clinical Trial
Public title
The Effect of Individual Sexual Councelling on Psychsocial Status of Post MI Patients- Single-Blinded Randomised Clinical Trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Marriage ; 20 years and older ; Suffering MI ; To have sexual activity before MI ; Ability for reading and writing Exclusion criteria : Erection disorder ; Urinary inconsistency ; Uncured psychological illness ; Motor disorder
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Tabriz University of Medical Sciences
Street address
Tabriz
City
Tabriz
Postal code
Approval date
2014-09-20, 1393/06/29
Ethics committee reference number
9386
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Sexual satisfaction
Timepoint
Before intervention and 6 weak after intervention
Method of measurement
NSSS Questionaire
Secondary outcomes
1
Description
Anxiety, Depression, Quality of Life
Timepoint
Before intervention and 6 weak after intervention
Method of measurement
HADS and QOLI IV Questionaires
Intervention groups
1
Description
Intervention in this study is verbal and written individual exercise and sexual consultation for 20 minutes for per sample in intervention group.
Category
Rehabilitation
2
Description
In control group don't practice any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Shahid Madani Educational Hospital
Full name of responsible person
Dr Hassankhani, Hadi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Scienses
Full name of responsible person
Mohgan Mirghafoorvand
Street address
research adminstration
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Scienses
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
Tabriz University of Medical Sciense
Full name of responsible person
Dr Hassankhani, Hadi
Position
Ph.D
Other areas of specialty/work
Street address
Tabriz University of Medical Sciense
City
Tabriz
Postal code
Phone
+98 41 3479 9946
Fax
Email
hassankhanih@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciense
Full name of responsible person
Dr Hassankhani, Hadi
Position
Ph.D
Other areas of specialty/work
Street address
Tabriz University of Medical Sciense
City
Tabriz
Postal code
Phone
+98 41 3479 9946
Fax
Email
hassankhanih@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bakhtiari, Jafar
Position
nursing student
Other areas of specialty/work
Street address
Tabriz
City
Tabriz
Postal code
Phone
Fax
Email
jafar.bakhtyari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)