Determining the effect of puberty health education on mothers and girls on general self-efficacy of Ghaemshahr female public school students
Design
The clinical trial has a control group and two interventional groups, community based and pragmatic, with parallel and randomized groups in the classification method.
Settings and conduct
The intervention was conducted on 150 female students aged 13 and 14 years old, one year old from their menstruation, and 7th and 8th grade students in Ghaemshahr high school girls, and 50 of their mothers. A randomized sampling will be classified. In the first step, three schools will be selected from the education system and from each selected school, 10 students from the seventh and eighth grades will be randomly selected and, if the student is satisfied, And his or her parents to participate in the research, pre-test questionnaires will be completed by them. Then, based on the homogeneity of the mean score of the pre-test performance, each school will be randomly assigned to intervention and control groups. The education of puberty health will include lectures and presentations to intervention teams.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Having the age of 13 - 14 years
2. Having real mothers
3- Passing at least one year from the menstrual period as they say
4- Education in Ghaemshahr State Schools
Exclusion criteria :
1- Study in non-governmental schools of Qaemshahr
2. Education other than the seventh and eighth
Intervention groups
Group 1: Community Health Nurse Group: 4 lecture sessions and using educational aids
Group 2: Mothers-trained group: Mothers' training (previously seen in community education nurses at two 90-minute sessions) is given to their daughters at home.
Control group: Without intervention, at the end of the study, receive educational pamphlets.
Main outcome variables
Public self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040461N1
Registration date:2018-12-29, 1397/10/08
Registration timing:registered_while_recruiting
Last update:2018-12-29, 1397/10/08
Update count:0
Registration date
2018-12-29, 1397/10/08
Registrant information
Name
Simin Khatirpasha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
khatirpasha.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-01, 1397/08/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
2018-11-06, 1397/08/15
Actual recruitment end date
2019-02-04, 1397/11/15
Trial completion date
2019-02-04, 1397/11/15
Scientific title
The effect of puberty health education on mothers and girls on general self-efficacy of Ghaemshahr public school girls in 2018
Public title
Evaluation of puberty health education on girl's self-efficacy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Having an age of 14-13 years
2. Pass at least one year from the time period, according to your statement
3. Not having chronic physical or mental illness
4. Students at Ghaemshahr girls' high school
5. Girls who live with their true mothers.
Exclusion criteria:
Absence of a student at the seventh and eighth grade
Age
From 13 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
By random sampling with a draw from the list of government schools in Ghaemshahr, three schools will be randomly selected (two schools for intervention groups 1 and 2 and one for the control group). From Schools
Intervention and control groups are selected individually and randomly from the list of students of each base in each school by drawing lots to the required number and completing 50 individuals in each intervention group to conduct a sample study.
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
Ethics committee of Iran University of Medical Sciences
Street address
, Iran University of Medical Sciences, next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.342
Health conditions studied
1
Description of health condition studied
Puberty health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
General Self-Efficacy
Timepoint
Before training and 12 weeks after puberty health education
Method of measurement
Sherer General Self-efficacy Inventory
Secondary outcomes
empty
Intervention groups
1
Description
intervention group 1: training in the form of 4 half-hour training sessions, question and answer lecture, and the use of teaching aids (slideshows for educational materials in the field of physical health (skin and hair, menstruation, physical activity, and rest and nutrition) , psychological and social maturity.
Category
N/A
2
Description
The intervention group 2: The mothers' training group, where the mothers are previously trained in two 90-minute training sessions by the health nurse, and they train their daughters at home.
Category
N/A
3
Description
Control group: There is no special intervention; at the end of the intervention, educational pamphlets receive the same as the other two groups.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaemshahr State Schools
Full name of responsible person
simin khatirpasha
Street address
Education Department, Danesh Street
City
Qaemshahr
Province
Mazandaran
Postal code
4763634618
Phone
+98 11 4222 5017
Email
robatkarim@iums.ac.ir
Web page address
http://qaemshahr.mazand.medu.ir/fa/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malekoti
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@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
Marhamat Farahaninia
Position
Master of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Iran, Rashid Yasemi Street, above Vanak Square, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
mary_f2008@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marhamat Farahaninia
Position
Master of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Iran, Rashid Yasemi Street, above Vanak Square, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
mary_f2008@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marhamat Farahaninia
Position
Master of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Iran, Rashid Yasemi Street, above Vanak Square, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
mary_f2008@yahoo.com
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
Only part of the data, such as the original outcome information
When the data will become available and for how long
Start the access period 1 year after the print results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
If they are similar in the type of statistical methods or statistical community.
From where data/document is obtainable
Using the email address author skhatirpasha@yahoo.com
Library of the Faculty of Nursing and Midwifery, Iran University of Medical Sciences
What processes are involved for a request to access data/document
First, the request email is sent to the author and the author will send the confirmation email to the requestor after confirmation and acceptance.