Protocol summary

Study aim
Comparing the effect of face to face and multi-media sexual education on satisfaction and Sexual Function of Afghan Adolescent Women
Design
Semi-experimental intervention with control group
Settings and conduct
Place: Health centers in Mashhad
Participants/Inclusion and exclusion criteria
Afghan teenage women ages 10-24 Ability to communicate in Persian language official marriage First marriage Monogamous couples Duration of marriage for at least one year Lack of sex education history Lack of medical conditions Drug addiction in research unit and his wife Non-occurrence of adverse events in the last 6 months non-Pregnancy and non-delivery in the last 3 months Live with my spouse at home now Having active sex
Intervention groups
face to face Sexual education in the first intervention group Multimedia sexual education in the second intervention group
Main outcome variables
Sexual satisfaction Sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180611040054N1
Registration date: 2018-07-13, 1397/04/22
Registration timing: registered_while_recruiting

Last update: 2018-07-13, 1397/04/22
Update count: 0
Registration date
2018-07-13, 1397/04/22
Registrant information
Name
Razia Hakimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1256 7624
Email address
hakimi.r@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Two Methods of Face to Face and Multimedia Sexual Education on Sexual Satisfaction and Sexual Function in Female Afghan’s Adoleacents.
Public title
Sexual Education on Sexual Satisfaction and Sexual Function
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Afghan teenage women ages 10 to 24 years old Ability to communicate in Persian language official marriage First marriage of couples Monogamous couples Duration of marriage is at least one year Lack of formal and comprehensive sexual education history Not having medical conditions Non-drug addiction and psychosis in couples Non-occurrence of adverse events in the last 6 months Pregnancy and non-delivery in the last 3 months Live with her spouse at home now Having active sex
Exclusion criteria:
Age
From 10 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی ایران
Street address
Iran University of Medical Sciences، Hemat Highway next to Milad Tower، TEHRAN
City
TEHRAN
Province
Tehran
Postal code
1449614535
Approval date
2018-06-02, 1397/03/12
Ethics committee reference number
IR.IUMS.REC.1397.027

Health conditions studied

1

Description of health condition studied
Sexual education in face to face and multimedia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual satisfaction
Timepoint
At first. Immediately. 2months later
Method of measurement
questionnaire

2

Description
Sexual function
Timepoint
At first. Immediately. 2months later
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: The training will not be given and will be given educational multimedia at the end of the training course.
Category
Other

2

Description
Intervention group: face to face Sexual education
Category
Other

3

Description
Intervention group: multimedia Sexual education
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Mashhad, in the areas with the highest incidence of Afghan women
Full name of responsible person
Razia Hakimi
Street address
Mashhad. Golshahr Shahid Shafiei Street. Shahid Shafi'i alley 30. Plaque 222.
City
mashhad
Province
Razavi Khorasan
Postal code
9156967179
Phone
+98 51 3256 7624
Email
hakimi.r@tak.iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Syed Kazem malakouti
Street address
Iran University of Medical Sciences. Hemat Highway next to Milad Tower. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6650 9024
Email
kmalakouti@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Razia Hakimi
Position
midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad. Golshahr Shahid Shafiei Street, Shahid Shafiei Street. Plaque 222
City
mashhad
Province
Razavi Khorasan
Postal code
9159967179
Phone
+98 51 3256 7624
Email
hakimi.r@tak.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Faculty of Nursing and Midwifery of Iran. Rashid Yasemi Street. Valiasr Street. Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shivakheirkhah1345@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Razia Hakimi
Position
Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad. Golshahr Shahid Shafiei Street, Shahid Shafiei Street. Plaque 222
City
mashhad
Province
Razavi Khorasan
Postal code
9156967179
Phone
+98 51 3256 7624
Email
hakimi.r@tak.iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The personal information of the participants and their names will not be published based on informed consent and ethical codes.
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
The thesis will be available to individuals after approval and defense, which includes the process of work and the statistical and specific results. Participants information will be protected
When the data will become available and for how long
After 1398
To whom data/document is available
All scholars and students in the private and public sectors
Under which criteria data/document could be used
For use in research and education at universities
From where data/document is obtainable
doctor masoomeh kheirkhah. address: Faculty of Nursing and Midwifery of Iran. Rashid Yasemi Street. Valiasr Street. Tehran.shivakheirkhah1345@gmail.com. Razia hakimi. address: Faculty of Nursing and Midwifery of Iran. Rashid Yasemi Street. Valiasr Street. Tehran.hakimi.r@tak.iums.ac.ir
What processes are involved for a request to access data/document
Request is sufficient by using an official email
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