The Effect of Educational Intervention Based on Information- Motivation and Behavioral Skills(IMB) Theory on Sexual Assertiveness and Self efficacy of Women with High-risk Sexual Behaviors
Determining the Impact of Educational Intervention Based on Information- Motivation and Behavioral Skills(IMB) Theory on Sexual Assertiveness and Self efficacy of Women with High-risk Sexual Behaviors
Design
Clinical trial with control group, with parallel groups, one blind, randomized
Settings and conduct
This study will be conducted on 70 women with sex risky behaviors at two DIC centers. each center will be allocated to one of intervention and control groups. In each group 35 patients are entered in the study.
Participants/Inclusion and exclusion criteria
she should have a written informed consent. be Iranian. be Muslim. she shouldn`t have speech, audio or accent problems that prevent communication with the researcher. she should be 18 to 50 years old. she should not have psychological disease (according to medical records) that impedes concentration and education. she should have at least one of the following: prostitution in exchange for money; Multiple sexual partners in the last year; Having a sex partner with more than one partner; Having sex partners who inject drugs; History of drug injection.
Intervention groups
Individuals are entered into the study after obtaining informed consent;upon completion of relevant questionnaires, intervention group pass four educational courses based on IMB Teory with 2-3 days intervals; post-test and follow-up are immediately after completing training sessions and 8 weeks after completing initial questionnaires, respectively.
Group control has not received intervention by researcher and at the same time they complete related questionnaires like the intervention group, and finally they receive a compact training pamphlet of education.
Main outcome variables
Sexual Assertiveness and Self efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180525039826N1
Registration date:2018-09-06, 1397/06/15
Registration timing:registered_while_recruiting
Last update:2018-09-06, 1397/06/15
Update count:0
Registration date
2018-09-06, 1397/06/15
Registrant information
Name
Marzieh Hassanshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3432 3301
Email address
hasanshahim941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Intervention Based on Information- Motivation and Behavioral Skills(IMB) Theory on Sexual Assertiveness and Self efficacy of Women with High-risk Sexual Behaviors
Public title
The Effect of Educational Intervention on Sexual Assertiveness and Self efficacy of Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
she should have a written informed consent to engage in research.
she should be Iranian.
she should be Muslim.
she should be 18 to 50 years old.
According to the case at the center or personal statements, she should have at least one of the following: prostitution in exchange for money, multiple sexual partners in the last year, having a sex partner with more than one partner, having sex partners who inject drugs, history of drug injection
Exclusion criteria:
she has speech, audio or accent problems that prevent communication with the researcher.
she has a psychological disease (according to medical records) that impedes concentration and education.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
we hold a lottery using a black plastic, from which two DIC ( drope in center) especial centers of women , the first one is assigned as control group and the other to the intervention, then at each center, sampling in an accessible manner was performed with informed consent.
Blinding (investigator's opinion)
Single blinded
Blinding description
To prevent the publication of information, each center is randomly assigned (through the center-name lottery) to one of the two intervention or control groups And women do not know which groups are assigned and what training is given in the other group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology, Mashhad University of Medical Sciences, No 18, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.MUMS.REC.1397.053
Health conditions studied
1
Description of health condition studied
sexual assertiveness and self efficacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual Assertiveness Score
Timepoint
Before the intervention, immediately after the completion of training sessions and eight weeks after the pre-test
Method of measurement
Sexual AssertivenessQuestionnaire
2
Description
Sexual Self efficacy Score
Timepoint
Before the intervention, immediately after the completion of training sessions and eight weeks after the pre-test
Method of measurement
Sexual Self efficacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, four 90-minute training sessions based on the information - motivation and behavioral skills model(IMB) was performed within 2 to 3 days intervals. Classes format includes lecture, video broadcasting, role playing and group discussion.
Category
N/A
2
Description
Control group: Do not get an intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Toos Women's DIC Center
Full name of responsible person
Moosavi
Street address
Toos Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
hasanshahim941@mums.ac.ir
2
Recruitment center
Name of recruitment center
Khaje Rabi Women's DIC Center
Full name of responsible person
Bakhtiyari
Street address
Balal Streat
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
hasanshahim941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University Deputy of Research and Technology, Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
hasanshahim941@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Hassanshahi Raviz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ghaffari Street
City
Rafsanjan
Province
Kerman
Postal code
7718637513
Phone
+98 34 3432 3301
Fax
Email
hasanshahim941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Raheleh Babazadeh
Position
PhD in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Doctora Intersection, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
babazadehr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marzieh Hassanshahi Raviz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ghaffari Street
City
Rafsanjan
Province
Kerman
Postal code
7718637513
Phone
+98 34 3432 3301
Fax
Email
hasanshahim941@mums.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available