Protocol summary

Study aim
Determining of the effect of education based on sexual self-efficacy on marital satisfaction in women
Design
The researcher collects the data using a questionnaire by referring to the subjects and explaining the purpose of the study for them and obtaining their consent to participate in the study. A pre-test is conducted. The data collection tool is a demographic data form for the units of the study, Vaziri's self-efficacy questionnaire (designed based on Schwarz's self-efficacy questionnaire) and ENRICH Marital Satisfaction Questionnaire. In sessions, genital anatomy topics for women and men, genital and reproductive physiology, and then sexual cycle in men and women, and the ability to solve sexual problems, and ultimately increase self-efficacy through lectures and questions and answers. After 6 weeks of the last session in the intervention group and 6 weeks after the pretest, the questionnaires were again filled in the control group. The samples were selected using random sampling method. They were randomly assigned to two intervention and control groups using health records. 40 people were calculated for each group
Settings and conduct
Health center of Ladan in Isfahan
Participants/Inclusion and exclusion criteria
Criteria for entering the study; the samples should be between 20-45 years of age and free of any physical illness, such as renal, cardiac, pulmonary, ..., sexual, psychological, medical, and drug and alcohol addiction. Exclusion criteria: no attendance at training sessions; getting pregnant during the study.
Intervention groups
Organizing a self-efficacy class for intervention group, a 2-hour training session per week for 4 weeks for groups of 10 participants. For the control group, there is no classroom, but at the end of the training package they will receive the instructional data in the classroom.
Main outcome variables
The first self-efficacy variable was evaluated before the intervention and 6 weeks after the intervention using the Wazirie's self-efficacy questionnaire (designed based on Schwarz's self-efficacy questionnaire); The second variable of marital satisfaction, which was assessed before and after 6 weeks of intervention by the Enrique Marital Satisfaction Short Questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180114038352N1
Registration date: 2018-02-09, 1396/11/20
Registration timing: registered_while_recruiting

Last update: 2018-02-09, 1396/11/20
Update count: 0
Registration date
2018-02-09, 1396/11/20
Registrant information
Name
Sabiheh Shokrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4229 2872
Email address
shokranis@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Education based on sexual self-efficacy on marital satisfaction in women referred to health centers in Isfahan in 2017.
Public title
The Effect of Education based on sexual self-efficacy on marital satisfaction in women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The samples should be between 20-45 years of age free of any physical illness, such as renal, cardiac, pulmonary, ..., sexual, psychological, medical, and drug and alcohol addiction.
Exclusion criteria:
Single women, pregnant women, postmenopausal women, any physical or mental illness, alcoholism or drug addiction
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Odd number or Even number Based on file number
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
The Ethics Committee of Islamic Azad University of Najafabad Branch
Street address
Daneshgah Ave
City
Najafabad
Province
Isfehan
Postal code
8514143131
Approval date
2017-12-07, 1396/09/16
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1396.72

Health conditions studied

1

Description of health condition studied
Marital satisfaction
ICD-10 code
Z70.0
ICD-10 code description
Counseling related to sexual attitude

Primary outcomes

1

Description
Sexual self-efficacy
Timepoint
Before intervention and 6 weeks after intervention (holding an educational class)
Method of measurement
self-efficacy questionnaire (based on Schwarz's self-efficacy questionnaire)

2

Description
Marital Satisfaction Score in Enrich questionnaire
Timepoint
Before intervention and 6 weeks after intervention (holding an educational class)
Method of measurement
Enrich Marital Satisfaction questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pre test is held and then divided into 4 groups of 10, and a 2-hour training session is held each week for 4 weeks. In sessions, genital and anatomical topics for women and men, genital and reproductive physiology, and then sexual cycle In men and women, the ability to solve sexual problems and ultimately increase sexual self-efficacy through lectures and questions and answers. After 6 weeks of the last session in the intervention group, the questionnaires were completed again.
Category
Other

2

Description
Control group: Pretest is performed and then six weeks after the pretest in the control group again, the questionnaires are completed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ladan Health Center
Full name of responsible person
sabiheh shokrani
Street address
Ashrafi Isfahani Blvd
City
Isfahan
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2872
Email
shokranis@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Islamic Azad University of Najafabad Branch
Street address
Daneshgah Ave
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2929
Email
shokranis@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
sabiheh shokrani
Position
Instructor and Faculty Member of the University
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Daneshgah Ave
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2872
Email
shokranis@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
sabiheh shokrani
Position
Instructor and Faculty Member of the University
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Daneshgah Ave
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2872
Email
s.shokrani@pmi.iaun.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
sabiheh shokrani
Position
Instructor and Faculty Member of the University
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Daneshgah Ave
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2872
Email
s.shokrani@pmi.iaun.ac.ir

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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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