1. Home
  2. Approved trials
  3. » فارسی

The effect of couples counseling based on CHARMS model on quality of sexual life and marital satisfaction of wives of men with myocardial infarction referred to Seyed Al-Shohada Heart educational and medical Center in Urmia

Protocol summary

Study aim
Determination the effect of couples counseling based on CHARMS model on sexual quality of life and marital satisfaction of wives of men with myocardial infarction
Design
A controlled, parallel-group, unblinded, randomized clinical trial of 90 women. Even and odd method will be used for randomization.
Settings and conduct
This two-group, unblinded, clinical trial study will be conducted on 90 spouses of MI patients at Seyed al-Shaheda hospital in Urmia. The intervention group will receive 6 sessions of sexual training and counseling based on the CHARMS model, but the control group will receive only routine training.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Being between 35 and 65 years old Living with spouse at the time of research Definite diagnosis of Myocardial infarction for husband At least 6 months have passed since husband Myocardial infarction. Exclusion Criteria: Having psychological trauma in the last 6 months for couples and Participating in similar research projects in the last three months
Intervention groups
Intervention group: 6 sexual counseling sessions based on the CHARMS method, 45 minutes per session, including: heart attack disease, the effect of the disease on the sexual activity of couples, establishing communication and gaining the trust and cooperation of couples, assessing the mental and physical health of people, discovering sexual problems, providing solutions Strengthening the empathetic and open-ended conversation, sexual conversation with the spouse, explaining the secrets of attractiveness and fashion, helping to maintain the verbal and emotional relationship with the spouse, and emphasizing the importance of flirting and making love about the warning signs of heart disease during intimacy. Control group: They will only receive training, counseling and routine care.
Main outcome variables
sexual Quality of life, Marital Satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240218061046N1
Registration date: 2024-02-26, 1402/12/07
Registration timing: prospective

Last update: 2024-02-26, 1402/12/07
Update count: 0
Registration date
2024-02-26, 1402/12/07
Registrant information
Name
delniya ghafuri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 3750
Email address
ronak.ghafuri65@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of couples counseling based on CHARMS model on quality of sexual life and marital satisfaction of wives of men with myocardial infarction referred to Seyed Al-Shohada Heart educational and medical Center in Urmia
Public title
The effect of couples counseling based on CHARMS model on quality of sexual life and marital satisfaction of wives of men with myocardial infarction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 35 and 65 years old Living with spouse at the time of research Definite diagnosis of Myocardial infarction for husband At least 6 months have passed since husband Myocardial infarction
Exclusion criteria:
Having psychological trauma in the last 6 months for couples Participating in similar research projects in the last three months
Age
From 35 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
90 spouses of myocardial infarction patients will be assigned to two intervention and control groups (45 people in each group) based on the criteria for entering the study and using the convenience selection method. In this way, the spouses of odd codes will be placed in the intervention group and the spouses of even codes will be in the control group, and it will continue until the number 90.
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 Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, at the end of Jihad St, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-07-10, 1402/04/19
Ethics committee reference number
IR.UMSU.REC.1402.101

Health conditions studied

1

Description of health condition studied
Myocardial infarction
ICD-10 code
I25.2
ICD-10 code description
Old myocardial infarction

Primary outcomes

1

Description
sexual quality of life
Timepoint
Before and one month after the intervention
Method of measurement
The Sexual Quality of Life-Female (SQoL-F) questionnaire (Symonds et al 2005)

2

Description
Marital Satisfaction
Timepoint
Before and one month after the intervention
Method of measurement
ENRICH Marital Satisfaction Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 6 sexual counseling sessions based on the CHARMS method, 45 minutes per session, including: heart attack disease, the effect of the disease on the sexual activity of couples, establishing communication and gaining the trust and cooperation of couples, assessing the mental and physical health of people, discovering sexual problems, providing solutions Strengthening the empathetic and open-ended conversation, sexual conversation with the spouse, explaining the secrets of attractiveness and fashion, helping to maintain the verbal and emotional relationship with the spouse, and emphasizing the importance of flirting and making love about the warning signs of heart disease during intimacy.
Category
Lifestyle

2

Description
Control group: They will only receive training, counseling and routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyedoshohada Hospital
Full name of responsible person
Dr.Alireza Mahoori
Street address
In front of Shahid Samadzadeh Street, 17 Shahrivar Boulevard, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
shohada.h@umsu.ac.ir
Web page address
https://sshohada.umsu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Yousef Mohammadpour
Street address
Urmia University of Medical Sciences, at the end of Jihad St, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7348
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Delnya Ghafouri
Position
Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, University of Medical Sciences, 11th kilometer of Sarvo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4961
Email
delniyaghafuri.1369@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Soheila Rabieipoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, University of Medical Sciences, 11th kilometer of Sarvo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4961
Email
soheila80@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Delnya Ghafouri
Position
Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, University of Medical Sciences, 11th kilometer of Sarvo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4961
Email
delniyaghafuri.1369@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Loading...