To determine the effect of puberty health education on the quality of life of girls aged 10 to 13 years
Design
This study is a randomized field trial with a control group.
Settings and conduct
This study will be conducted at the girl's public elementary schools in the west region of Tehran. The fifth- and sixth-grade students and their mothers meeting the inclusion criteria, will complete the Pediatric Quality of Life Inventory and KID Screen before the intervention. 45 days after the intervention and six months after the intervention, the questionnaires will again be completed by the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: female students aged 10 to 13 years and their mothers; exclusion criteria: lack of parental permission for students' participation in the study, inability to use smart phone
Intervention groups
The intervention group will receive an educational application on puberty health. The program has been set based on five 90-minute sessions for the students and three 90-minute sessions for their mothers during 5 weeks.
The control group will not receive any education.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180523039789N1
Registration date:2019-06-17, 1398/03/27
Registration timing:registered_while_recruiting
Last update:2019-06-17, 1398/03/27
Update count:0
Registration date
2019-06-17, 1398/03/27
Registrant information
Name
Maryam Gharacheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8867 1613
Email address
gharacheh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of puberty health education on the quality of life of girls aged 10 to 13 years
Public title
Effect of puberty health education on the girls' quality of life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Girls aged 10 to 13 years and their mothers
The absence of underlying illnesses
Having a smartphone or tablet under Android and IOS system
Exclusion criteria:
Lack of parental permission for students' participation in the study
Inability to use smartphone
Age
From 10 years old to 13 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization will be conducted in two steps. In the first step, schools will be selected using the stratified random method and divided into several similar classes. From each class, one school will be allocated to the intervention group and another one to the control group, by ballot. Then, among each selected school, twenty students meeting the inclusion criteria, will equally be selected using the list of the fifth- and sixth-grade students through a random number table.
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, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.IUMS.REC.1398.203
Health conditions studied
1
Description of health condition studied
Quality of life
ICD-10 code
Z71.9
ICD-10 code description
Counseling, unspecified
Primary outcomes
1
Description
Quality of life
Timepoint
Baseline, 45 days after the intervention and 6 months after the intervention
Method of measurement
Pediatric Quality of Life Inventory TM 4.0, KID Screen
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention includes a smartphone application on puberty health that will be available to eligible female students and their mothers. Its content includes physiology of puberty, changes during puberty, menstruation, premenstrual syndrome and nutrition during puberty.The mothers will receive an activation code after training. Then, with this code, the application will be activated for the student and they will be able to use it and receive the education. This program has been set based on five 90-minute sessions for students and three 90-minute sessions for their mothers during 5 weeks.
Category
Behavior
2
Description
Control group: will not receive any education.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
primary schools in Tehran
Full name of responsible person
Sedigheh Khanjari
Street address
School of nursing and midwifery, Rashid Yasemi St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8867 1613
Email
s-khanjari@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
seyed kazem malakouti
Street address
Iran university of medical sciences, Hemat Exp
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1111
Email
kmalakouti@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
Sedigheh Khanjari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Rashid Yasemi St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8867 1613
Email
s-khanjari@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sedigheh Khanjari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Rashid Yasemi St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8867 1613
Email
s-khanjari@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Gharacheh
Position
Assistant professorَ
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of nursing and midwifery, Rashid Yasemi St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8867 1613
Email
gharacheh.m@iums.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
Not applicable
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