Protocol summary

Summary
Objectives: To assess the effect of group education versus no education on sexual knowledge and attitude of student girls at high-risk of sexual behavior. Design: a randomized clinical trial. Setting and conduct: The eligible student girls at high-risk of sexual behavior who are educating at Hamadan University of Medical Sciences during the study period will be enrolled into the trial. Inclusion criteria: age of 18 to 20 years; first year student; single; mild to moderate score of knowledge and attitude. Exclusion criteria: having physical or mental diseases; absence of educational sessions more than one session. Intervention group: Educational session 90 minutes twice a week for 3 weeks. Control group: No education. Primary outcome: Assessing the sexual knowledge and attitude of student before and after education using standard questionnaire. Secondary outcome: Nothing. Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. Blinding: Not possible.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201610039014N120
Registration date: 2016-10-13, 1395/07/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-10-13, 1395/07/22
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group education versus no education on sexual knowledge and attitude of student girls at high-risk of sexual behavior: a randomized clinical trial
Public title
The effect of group education versus no education on sexual knowledge and attitude of student girls at high-risk of sexual behavior
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 to 20 years; first year student; single; mild to moderate score of knowledge and attitude. Exclusion criteria: having physical or mental diseases; absence of educational sessions more than one session.
Age
From 18 years old to 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. Blinding: Not possible.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-07-16, 1395/04/26
Ethics committee reference number
IR.UMSHA.REC.1395.221

Health conditions studied

1

Description of health condition studied
student girls at high-risk of sexual behavior
ICD-10 code
Z72.5
ICD-10 code description
High-risk sexual behaviour

Primary outcomes

1

Description
Assessing the sexual knowledge and attitude of student
Timepoint
Before and after education
Method of measurement
Using standard questionnaire

Secondary outcomes

1

Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing

Intervention groups

1

Description
Educational session 90 minutes twice a week for 3 weeks
Category
Other

2

Description
No education
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Satari Mahtab
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Satari Mahtab
Position
Midwifery Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
mahtabsattari212@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Dr Farzaneh Soltani
Position
Fertility Health Specialist
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
farzanehsoltani2008@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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