Protocol summary

Study aim
The Effect of Comprehensive Couple Education (CCE) Program on Attitude Extramarital Relations, Marital Satisfaction, and Conflict in Couples with Sexual Dysfunction
Design
A Triple-blinded, Randomized, Placebo-controlled Trial with parallel groups
Settings and conduct
This study will be conducted on 100 couples with sexual dysfunction, referred to health or counseling centers in Ilam. Assistance's researchers who will perform registration of samples in different centers, in the case of a couple in accordance with the criteria for entering the study, in a phone call with the assistance's researchers 1, according to a computer table, the couple will be placed in one of the intervention or control groups. In order to blindness, registration, allocation of participants in the intervention (comprehensive couple education) and control (nutritional education) groups, coding, gathering questionnaires and data-entering and data-analyzing is done by different people. Educators don,t know the educational content and the nature of the training for each group.
Participants/Inclusion and exclusion criteria
All Iranian couples with sexual dysfunction who do not have a drug dependency and mental illness.
Intervention groups
The intervention and control group will receive 12 hours of education (6 days 2 hours in three weeks). In the intervention group, CCE by the specialist team includes life skills, skill training for intimate and sexual partnership, mutual respect, spouse care, modern technology damage, and the proper use of social networks, recognition of sexual, emotional and Psychological and social values ​​will be implemented. But in the control group, nutrition education is given about hypertension, kidney, thyroid, diabetic, gastrointestinal diseases and AIDS.
Main outcome variables
Attitude toward extramarital relationship

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190603043804N1
Registration date: 2019-08-25, 1398/06/03
Registration timing: retrospective

Last update: 2019-08-25, 1398/06/03
Update count: 0
Registration date
2019-08-25, 1398/06/03
Registrant information
Name
Arezoo Haseli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3336 2173
Email address
ar_haseli@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Comprehensive Couple Education (CCE) in Attitude Extramarital Relations and Couple's Satisfaction and Conflict in Couple's Sexual Dysfunction
Public title
Effect of Comprehensive Couple Education in Prevention of Extramarital Relations
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
- Iranian couples with sexual dysfunction at least in one of the spouses
Exclusion criteria:
- lack of reading and writing literacy Addiction to drugs at least in one of the spouses based on self-reporting History of mental illness at least in one of the spouses based on self-reporting
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 200
More than 1 sample in each individual
Number of samples in each individual: 2
couple
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization unit is a couple. Randomization method will be blocked by using the site "www.rct.com" in four blocks. None of the samples know that will be allocated in which groups (allocation concealment).
Blinding (investigator's opinion)
Double blinded
Blinding description
Random allocation carried out by the researcher's assistance 1 and using www.rct.com. Registration and allocation of participants in intervention and control groups by the researcher's assistance 2 (2 people). The coding and collecting of questionnaires and data entry into the software will be done by the researcher's assistance 3. Implementation of the intervention (educators) will be conducted by the specialist team based on the specialized heading. Based on ethics, couples will be not blinded to the intervention. Educators will also be blind to this study. Providers only know that two types of training are given to the two groups of participants, but they will be unaware of the educational content and the nature of each training for each group. A person who measures the outcomes in two groups of intervention and control is a person other than the educators (researcher's assistance 3). For this purpose, the samples will complete their questionnaires but the researcher's assistance 3 will collect questionnaires and data entry into the software. Additionally, the person analyzing the results will be someone other than the people above so he will not know which one is intervention or control group it is using the A and B groups in the SPSS software.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773947
Approval date
2018-06-19, 1397/03/29
Ethics committee reference number
IR.SHMU.REC.1397.016

Health conditions studied

1

Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition

Primary outcomes

1

Description
Attitude Towards Extramarital Relationships
Timepoint
Before and after intervention, one month, one year and five years after intervention
Method of measurement
Attitudes toward infidelity scale

Secondary outcomes

1

Description
Marital Satisfaction
Timepoint
Before and after intervention, one month, one year and five years after intervention
Method of measurement
ENRICH Marital Inventory

2

Description
Marital Conflict
Timepoint
Before and after intervention, one month, one year and five years after intervention
Method of measurement
Marital Conflict Questionnaire

Intervention groups

1

Description
Intervention group: The intervention group will receive 12 hours of education (6 days 2 hours in three weeks). Comprehensive Couple Education by the specialist team based on heading includes life skills, skill training for intimate and sexual partnership, mutual respect, spouse care, modern technology damage, and the proper use of social networks, recognition of sexual, emotional and Psychological and social and spiritual values will be implemented.
Category
Behavior

2

Description
Control group: The control group will receive 12 hours of nutrition education (6 days 2 hours in three weeks) about hypertension, kidney, thyroid, diabetic, gastrointestinal diseases and AIDS.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
urologists offices
Full name of responsible person
Zahra Chenari
Street address
22-Bahman square
City
Ilam
Province
Ilam
Postal code
0000000000
Phone
+98 84 3336 2173
Email
Zahrach9675@gmail.com

2

Recruitment center
Name of recruitment center
Health Center
Full name of responsible person
Zahra Chenari
Street address
Ilam
City
Ilam
Province
Ilam
Postal code
0000000000
Phone
+98 84 3336 2173
Email
Zahrach9675@gmail.com

3

Recruitment center
Name of recruitment center
Couples Counseling Center
Full name of responsible person
Mona Nami
Street address
Seiedo-Shohada Blvd., Ilam Town
City
Ilam
Province
Ilam
Postal code
0000000000
Phone
+98 84 3336 2173
Email
mona.namii@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
Email
info@shmu.ac.ir
Web page address
http://www.shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Arezoo Haseli
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
693183437126
Phone
+98 84 3336 2173
Fax
Email
ar_haseli@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Shariati
Position
Associate Professor of Community Medicine
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Ministry of Health and Medical Education
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8836 3560
Email
shariati.ir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Arezoo Haseli
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
693183437126
Phone
+98 84 3336 2173
Fax
Email
ar_haseli@yahoo.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
Not applicable
Title and more details about the data/document
All of data
When the data will become available and for how long
After publication articles
To whom data/document is available
Researchers in academic Center
Under which criteria data/document could be used
None
From where data/document is obtainable
Responsible Author
What processes are involved for a request to access data/document
By Mail
Comments
Loading...