The purpose of the study is to determination effect of education, based on the Theory of Planned Behavior on preventive
behaviors of Sexually transmitted disease in women
Design
The research sample is determined after the pilot study. The random allocation between the two intervention and control groups is done by using closed envelopes and selecting them.
Settings and conduct
This study is a clinical trial conducted on two groups of intervention and control. Study population are women referred to the Ziaeian hospital affiliated to Tehran University of Medical Sciences. First, the researcher-made questionnaire are completed by women who have the entry criteria. The training program is delivered in four sessions. For the control group, no educational intervention is conducted and they only receive the training booklet two months after the intervention. Immediately and two months after the intervention, the questionnaires is completed by the two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: all women referred to the Ziaeian Hospital.
Exclusion Criteria: Refusing (No consent) to participate in the study. Having a certain physical or mental illness, being Illiterate, or being single.
Intervention groups
Intervention group receive the training program. No educational intervention is provided for the control group.
Effect of education, based on the Theory of Planned Behavior on preventive behaviors of Sexually transmitted disease in women
Public title
Effect of education, based on the Theory of Planned Behavior on preventive behaviors of Sexually transmitted disease in women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
women referred to the Ziaeian hospital
Exclusion criteria:
No consent to participate in the study
have a certain physical or mental illness
Illiterate
Single
Age
No age limit
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
The random allocation between two groups (Intervention and control) is done by using closed envelopes that are selected by the participants, which determine which group of intervention or control the participants are allocated to.
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
کمیته اخلاق دانشگاه علوم پزشکی تهران
Street address
Nosrat Ave, Tohid Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4228
Health conditions studied
1
Description of health condition studied
Sexually transmitted disease
ICD-10 code
A63.8
ICD-10 code description
Other specified predominantly sexually transmitted diseases
Primary outcomes
1
Description
preventive Behaviors from venereal Diseases
Timepoint
Before the intervention begins, Immediately and two months after intervention
Method of measurement
Use self - made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: First, the researcher-made questionnaire is completed by all subjects. Then, the training program for the intervention group is held in four sessions lasting 75 minutes. The planned behavior theory is used for training. Immediately and two months after the intervention the questionnaires are completed by the subjects again.
Category
Behavior
2
Description
Control group: No training intervention is made for the control group. They receive educational booklet two months after the intervention. Immediately and two months after the intervention, questionnaires are completed by the samples in control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaeian hospital
Full name of responsible person
Maryam Modares
Street address
Falah Sq, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 2700
Email
ma_modars@yahoo.com
Web page address
https://mg.mail.yahoo.com/neo/launch
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ali Sahraeean
Street address
Ghods Ave, Enghelab Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3686
Email
shamsef931@mums.ac.i
Web page address
https://mail.mums.ac.ir/owa/#path=/mail
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Shamsolahi
Position
Senior obstetrics undergraduate
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nosrat Ave, Tohid Sqe, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 2700
Email
shamsef931@mums.ac.ir
Web page address
https://mail.mums.ac.ir/owa/#path=/mail
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Modares
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Ave Nosrat, Tohid Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 2700
Email
ma_modars@yahoo.com
Web page address
https://mg.mail.yahoo.com/neo/launch
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Shamsolahi
Position
Senior obstetrics undergraduate
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nosrat Ave, Tohid Sq,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 2700
Email
shamsef931@mums.ac.ir
Web page address
https://mail.mums.ac.ir/owa/#path=/mail
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