Comparing the effectiveness of cognitive-behavioral therapy on sexual performance and self-efficacy in women with heart disease
Design
The samples will be included in the study and random allocation of people into two groups using the permutation block method (size of each block = 6) in the form of available samples and quota method (according to menopausal and non-menopausal women of reproductive age).
Settings and conduct
in Chaharmahal Bakhtiari province
Participants/Inclusion and exclusion criteria
- A resident of Shahrekord
- Having minimum reading and writing literacy to complete the questionnaires
- Women with class 1 or 2 heart disease confirmed by a doctor
- married
- Living with a spouse
- sexually active
- 3 years or more have passed since marriage
- Absence of known mental disorders in yourself and your spouse
- Absence of other known physical disorders in yourself and your spouse, such as thyroid, blood pressure, diabetes, cancers, etc.
- Absence of known sexual disorders in yourself and your spouse
- Having a mobile phone and the ability to connect to the Internet
Intervention groups
8 sessions of sexual cognitive behavioral therapy for the intervention group
Main outcome variables
sexual performance score; sexual self-efficacy score; intervention group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100524004015N2
Registration date:2024-11-03, 1403/08/13
Registration timing:registered_while_recruiting
Last update:2024-11-03, 1403/08/13
Update count:0
Registration date
2024-11-03, 1403/08/13
Registrant information
Name
Zeinab Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 1412
Email address
zeinab.tavakol@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-16, 1403/07/25
Expected recruitment end date
2024-11-15, 1403/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of cognitive-behavioral therapy on sexual performance and self-efficacy in reproductive age women with heart disease
Public title
Investigating the effectiveness of cognitive-behavioral therapy on sexual performance and self-efficacy in reproductive age women with heart disease
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
A resident of Shahrekord
Having minimum reading and writing literacy to complete the questionnaires
Women with class 1 or 2 heart disease confirmed by a physician
married
Living with a spouse
sexually active
3 years or more have passed since marriage
Absence of known mental disorders in yourself and your spouse
Absence of other known physical disorders in yourself and your spouse, such as thyroid, blood pressure, diabetes, cancers, etc.
Absence of known sexual disorders in yourself and your spouse
Having a mobile phone and the ability to connect to the Internet
Exclusion criteria:
Using medical or pharmaceutical interventions or counseling interventions to solve sexual problems
being pregnant
Alcohol use
Drug use
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples to two intervention and control groups, tables of 6 blocks (table of random numbers) will be used. In this way, a number is included for the names of the registered people, then using 6 block tables and random allocation software, these numbers are randomly placed in one of the two groups.
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 Shahrekord University of Medical Sciences
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2024-05-28, 1403/03/08
Ethics committee reference number
IR.SKUMS.REC.1403.030
Health conditions studied
1
Description of health condition studied
sexual activity
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual performance score
Timepoint
Before the start of the intervention - after the end of the intervention - one month after the end of the intervention
Method of measurement
The sexual performance questionnaire based on Schwarzer's general self-efficacy questionnaire was created by Vaziri and Lotfi Kashani.
2
Description
Sexual self-efficacy score
Timepoint
Before the start of the intervention - after the end of the intervention - one month after the end of the intervention
Method of measurement
Sexual self-efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
This study will be conducted on 60 women with heart disease in Shahrekord city. After obtaining the code of conduct and obtaining the necessary permits from the university, sampling will be done. Entry criteria include women living in Shahrekord and suffering from class one or two heart disease confirmed by a doctor, having minimum reading and writing literacy to complete the questionnaires, married, living with their spouse, sexually active, having been married for 3 years or more. , there are no known mental disorders in yourself and your spouse, other physical disorders such as thyroid, blood pressure, diabetes, cancers, etc. are not known in yourself and your spouse, and there are no known sexual disorders in yourself and your spouse. available and with a quota method (according to menopausal and non-menopausal women of reproductive age), will be included in the study through the health network and random allocation of people into two groups of 30 people will be done by the method of permutation blocks (size of each block = 6) . In addition to treatment and routine care, the intervention group will receive a course of CBT treatment for one month and in 8 sessions of 60 minutes. To prepare the content, the texts are first reviewed and after the content is approved by the professors of the psychology department and sexual health specialists, the study will be conducted by the researcher who has acquired the necessary training and skills and provides a valid certificate. Meetings are held virtually in Sky Room.
Category
Treatment - Other
2
Description
Control group: The control group receives only the routine treatment and care that they used to control and treat the heart disease.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers affiliated to Shahrekord University of Medical Sciences and Imam Ali (AS) Heart
Full name of responsible person
Zainab Tavakol
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
:۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 1412
Email
zeinab.tavakol@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Elham Raeisi
Street address
Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 1412
Email
Raeisi.e@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Zeinab Tavakol
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 1412
Email
zeinab.tavakol@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Zeinab Tavakol
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 1219
Email
zeinab.tavakol@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Arani
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 1219
Email
fateme.mohammadi.1378@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All study data including demographic information, Sexual self-efficacy status and sexual performance index before and after the intervention can be published.
When the data will become available and for how long
Only after publishing the article extracted from this data can be published.
To whom data/document is available
Researchers related to the research field
Under which criteria data/document could be used
In order to generalize the results of the research, after the publication of the article, if the researcher has a convincing reason to use the data and undertakes to refer to the information of this research.
From where data/document is obtainable
Send your request to the responsible person's email.
What processes are involved for a request to access data/document