determine the effect of discharge plan program on sexual knowledge and quality of life of patient after Invasive coronary intervention
Design
allocated to 2 group intervention give discharge plan consult and conventional education
Settings and conduct
in post cath ward of shahid beheshti hospital (kashan) after patient assessment and allocation in 2 groups by main researcher(assistant professor), the student (intern) should intervention (presentation and delivering the sexual activity package )
Participants/Inclusion and exclusion criteria
all of patient under PTCA or CABG intervention at discharging time
Intervention groups
patients that receive with discharge sexual activity package at discharging time
Main outcome variables
sexual knowledge and sexual quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100829004655N8
Registration date:2018-03-19, 1396/12/28
Registration timing:registered_while_recruiting
Last update:2018-03-19, 1396/12/28
Update count:1
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of discharge plan box on knowledge and Sexual Quality of Life in post CABG and PTCA patients
Public title
effect of discharge planing on knowledge and Sexual Quality of Life in patient
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
patient can read and write
patient must be married and living with partner
patient should not have any known sexual dysfunction
patient should not have any known psychological disorder
hospitalized patient in post ICU open heart or post Catheterization
patient should not have any limitation in sexual activity
Exclusion criteria:
heart, liver, pulmonary and kidney failure or malignancy or any systemic disease
use of antipsychotic or cytotoxic drug
severe heart failure (function class III or IV (NYHA))
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is continuous and patients are divided into 4 randomized blocks between intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
patients have no information about the kind of consultation that receive
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
•Ethics committee of kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Kashan
City
kaushan
Province
Isfehan
Postal code
8715981151
Approval date
2018-01-01, 1396/10/11
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.97
Health conditions studied
1
Description of health condition studied
Chronic ischemic heart disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
sexual knowledge
Timepoint
baseline and 2 month after dischage
Method of measurement
sexual knowledge questionnaire in cardiac patient
2
Description
sexual quality of life
Timepoint
baseline and 2 month after dischage
Method of measurement
Abraham sexual quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: consult with discharge plan
Category
Rehabilitation
2
Description
Control group: conventional discharge plan
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز تحقیقات دانشگاه علوم پزشکی کاشان
Full name of responsible person
محسن تقدسی
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
sadatinejad71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidi Gholamali
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
sadatinejad71@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
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
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghadosi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
sadatinejad71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Farrokhian Alireza
Position
Faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran
City
kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
farrokhian.ar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sadatinejad Seyyed Mohsen
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
sadatinejad71@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
Not applicable
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only available to scholars working in academia and academia.
Under which criteria data/document could be used
If you observe the trust and mention the source, data is available for researchers.
From where data/document is obtainable
Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir
What processes are involved for a request to access data/document
After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion.