Determining the effect of educational program on the knowledge and attitude of primary school health care provider about children's sexual health
Design
A clinical trial with a control group, with parallel groups, one blind, randomized
Settings and conduct
After introduction of Mazandaran University of Medical Sciences to Mazandaran Education Department, the names of primary school health care provider and their Phone numbers will be extracted. Coordination will be done by phone and the invitation will be sent. After reviewing entry and exit criteria, 60 providers will be considered for inclusion in the study. By using table of random numbers, individuals will be randomly assigned to two groups of intervention and control. Intervention will be done in intervention group; there is no intervention in the control group at the time of the study. The training will be at the Nursing and Midwifery School, Mazandaran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Not interested in participating in the study
Absence in at least one of the training sessions
Intervention groups
Intervention will done in intervention group, there is no intervention in the control group at the time of the study.
Main outcome variables
Knowledge and Attitudes of Primary School Health Care Providers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161126031117N8
Registration date:2019-01-14, 1397/10/24
Registration timing:prospective
Last update:2019-01-14, 1397/10/24
Update count:0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-17, 1397/10/27
Expected recruitment end date
2019-02-21, 1397/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Children's sexual Health Educational Program on Knowledge and Attitudes of Primary School Health Care Providers
Public title
The Effect of Children's sexual Health Educational Program on Knowledge and Attitudes of Primary School Health Care Providers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Working in elementary school as a health care provider
Having at least one year teaching experiences
Exclusion criteria:
Not interested in participating in the study
Absence in at least one of the training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
By using table of random numbers , individuals will be randomly assigned to two groups of intervention and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants were blind if they were in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice –Chancellor for Research of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.MAZUMS.REC.1397.3140
Health conditions studied
1
Description of health condition studied
Children's sexual Health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Knowledge f Primary School Health Care Providers about children's sexual health
Timepoint
Before the intervention, immediately after the intervention and 4 weeks after the intervention
Method of measurement
Knowledge of Primary School Health Care Providers about children's sexual health questionnaire
2
Description
Attitudes of Primary School Health Care Providers about children's sexual health
Timepoint
Before the intervention, immediately after the intervention and 4 weeks after the intervention
Method of measurement
Attitudes of Primary School Health Care Providers about children's sexual health questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After introduction of Mazandaran University of Medical Sciences to Mazandaran Education Department, the names of primary school health care provider and their Phone numbers will be extracted. Coordination will be done by phone and the invitation will be sent. After reviewing entry and exit criteria, 60 providers will be considered for inclusion in the study. By using table of random numbers, individuals will be randomly assigned to two groups of intervention and control. Intervention will be done in intervention group; there is no intervention in the control group at the time of the study. The training will be at the Nursing and Midwifery School, Mazandaran University of Medical Sciences.
Category
Other
2
Description
Control group: The control group does not receive any intervention during the study and receives educational intervention and booklet at the end of the study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Education Department
Full name of responsible person
Reza Safaee Tabalvandani
Street address
Farhang St
City
Sari
Province
Mazandaran
Postal code
4819719336
Phone
+98 11 3332 7981
Email
rezasafaee1356@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Hedayati Zadeh
Street address
Vice Chancellor for Research of Mazandaran University of Medical Sciences, Moalem Square, Moalem Street. sari Mazandaran
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 11 3325 7230
Email
akbar_hedayati@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Barimani
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 11 3336 7342
Fax
Email
z.barimani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Soghra Khani
Position
PhD, Moderator (owner) of project
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 11 3335 8918
Fax
Email
s.khani@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Soghra Khani
Position
PhD, Moderator (owner) of project
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 11 3335 8918
Fax
Email
s.khani@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
En Data will only be available to researchers in academia and academia.
Under which criteria data/document could be used
Meta-analysis is allowed on data
From where data/document is obtainable
Sexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery school, Vesal street, Amir Mazandarani Boulvard. khanisog343@gmail.com
What processes are involved for a request to access data/document
After emailing and sending the profile, it will be sent within a week.