(1) Objective: The aim of this Experimental study is to compare the quality of life and sexual function in patients with ischemic heart disease before and after of self-care training program. (2) Design: This study is a randomized controlled clinical trial. (3) Setting and conduct: This study will be done at heart rehabilitation of Qom Shahid Beheshti hospital. Eligible subjects will be randomized to receive self-care training program and routine care in control group. (4) Participants including major eligibility criteria: This clinical trial will be carry out on 60 married patients with ischemic heart disease of both sex and aged more than 30 years. (5) Intervention: sixty patients with ischemic heart disease will be allocated randomly into two groups (intervention and control) and receive one of the following; self-care training program and routine care. In self-care training group, within first week of rehabilitation, sexual guideline will be provided by oral explanation and CD within only 60-minutein. Project manager speak to experimental group about heart disease and the risk of cardiac events during sexual activity, right time of start sex, precautions before it, medications and their side effects, the importance of choosing the correct location, correct positions, changes in vital signs and warning signs during sexual activity.
(6) Main outcome measures: Angina specific quality of life and sexual function will be measured before and one month after receiving self-care training program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090129581N2
Registration date:2016-11-14, 1395/08/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-14, 1395/08/24
Registrant information
Name
leila ghanbari afra
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3884 9038
Email address
lghanbari@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Qom University of Medical Sciences
Expected recruitment start date
2016-09-20, 1395/06/30
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self care educational program on sexual function and quality of life in patients with ischemic heart disease
Public title
Self care and sexual function in patients with ischemic heart disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: married; Lack of known mental illness; patients who have diagnosed coronary artery disease by cardiologists. Exclusion criteria: patients with congenital heart disease or valvular abnormalities after angiography.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Qom University of Medical Sciences
Street address
Research deputy of Qom university of Medical Sciences, number 3, Safashahr street, Qom.
City
Qom
Postal code
3713614975
Approval date
2016-05-03, 1395/02/14
Ethics committee reference number
IR.muq.Rec.1395.48
Health conditions studied
1
Description of health condition studied
Ischaemic heart disease
ICD-10 code
I20.0, I21
ICD-10 code description
Unstable angina, Acute transmural myocardial infarction of anterior wall, Acute transmural myocardial infarction of inferior wall, Acute transmural myocardial infarction of other sites, Acute transmural myocardial infarction of unspecified site, Acute sub
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention and a month after the study
Method of measurement
Arizona sexual function questionnaire (ASEX)
2
Description
Quality of life
Timepoint
Before the intervention and a month after the study
Method of measurement
Seattle quality of life questionnaire (SAQ)
Secondary outcomes
empty
Intervention groups
1
Description
Within first week of rehabilitation, sexual guideline will be provided by oral explanation and CD within only 60-minute. Project manager speak to intervention group about heart disease and the risk of cardiac events during sexual activity, right time of start sex, precautions before it, medications and their side effects, the importance of choosing the correct location, correct positions, changes in vital signs and warning signs during sexual activity.