Evaluating the Effectiveness of Enriching Marital Relationships Education on Couples' Sexual Health
Design
The study is a randomized controlled trial that 100 eligible candidate couples (200 people) will be randomly assigned to intervention and control (50 couples per group).
Settings and conduct
couples of both groups will complete the pretest questionnaire. Then, for the intervention group couples , an 18-hour workshop will be held in the form of six 3-hour workshops. The content of the workshop will be based on the content of the book on enriching marital and sexual relations Including skill training in marital relationships, effective communication, anatomy and the functioning of sexual organs and sexual problems. In the telegram group, the related messages will be uploaded and the couple's questions will be answered. Control group couples will not receive intervention. Four months after the intervention, both groups completed the post-test questionnaire.
Participants/Inclusion and exclusion criteria
Couples with a marriage history of 5 years or less, over 18 years of age and minimum secondary education, resident in the Isfahan city, both couples are willing to participate in the study and haven't psychiatric disorders and severe marital conflicts can entry to study but if one of the couples not willing to participate in study, so they can't inter to the study.
Intervention groups
For couples in the intervention group will implement the enrichment marital relationship training package.The control group does not receive intervention. Both intervention and control groups use routine services in health center for couples.
Main outcome variables
sexual information, motivation, behavioral skills, behavior and sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181211041926N1
Registration date:2019-03-02, 1397/12/11
Registration timing:retrospective
Last update:2019-03-02, 1397/12/11
Update count:0
Registration date
2019-03-02, 1397/12/11
Registrant information
Name
Fahimeh Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0025
Email address
f.bagherikho@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of Enriching Marital Relationships Education on Couples' Sexual Health
Public title
Evaluating the Effectiveness of Enriching Marital Relationships Education on Couples' Sexual Health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A marriage history of five years or less
Over 18 years
Minimum secondary schools education
Not having mental illness
Not having severe marital conflicts
Resident in the Isfahan city
The willingness of both (husband and wife) to participate in the study
Exclusion criteria:
Unwillingness of one of the couple(husband or wife) to participate in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method is used. the unit of randomization is couple that assigned to one of the intervention and control groups using the random number table.
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2017-01-17, 1395/10/28
Ethics committee reference number
IR.UMSHA.REC.1395.435
Health conditions studied
1
Description of health condition studied
sexual disorder
ICD-10 code
f52
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
sexual information
Timepoint
before and 4 month after intervention
Method of measurement
Researcher made questionnaire
2
Description
sexual motivation
Timepoint
before and 4 month after intervention
Method of measurement
Researcher made questionnaire
3
Description
sexual behavioral skills
Timepoint
before and 4 month after intervention
Method of measurement
Researcher made questionnaire
4
Description
sexual behavior
Timepoint
before and 4 month after intervention
Method of measurement
Researcher made questionnaire
Secondary outcomes
1
Description
sexual satisfaction
Timepoint
before and 4 month after intervention
Method of measurement
Larson sexual satisfaction scale
Intervention groups
1
Description
Intervention group: For the intervention group will be done. 18 hours of workshop, presentation of the book on sexual and marital skills training and the formation of a telegram group for presentation the message and question and answer
Category
Behavior
2
Description
Control group: Does not receive an intervention.Only receive health care services to couples in health centers.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Isfahan University of Medical Sciences
Full name of responsible person
Fahimeh Bagheri
Street address
Hamadan University of Medical Sciences,Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0025
Fax
+98 81 3838 0509
Email
f_bagherikho@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Babak Moeini
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0025
Fax
+98 81 3838 0509
Email
babak_moeini@yahoo.com
Grant name
Grant code / Reference number
9510286239
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Babak Moeini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0025
Fax
+98 81 3838 0509
Email
babak_moeini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Babak Moeini
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0025
Email
babak_moieni@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fahimeh Bagheri
Position
PhD condidate of health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0025
Email
f_bagherikho@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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data is related to the outcomes of the study being shared after being unconscious of the 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
Researchers working in scientific centers are allowed access to data upon request.
Under which criteria data/document could be used
Use of data is authorized by the Ethics Committee of Hamedan University of Medical Sciences.
From where data/document is obtainable
Submit a request by email to the main researcher at the address f_bagherikho@yahoo.com
What processes are involved for a request to access data/document
Submitting a request by email to main researcher, sending a request to the Ethics Committee of Hamadan University of Medical Sciences to investigate, if the Ethics Committee approves the request sending the data.