The effect of puberty health education for Daughters and mothers on Daughters’ self-esteem
Design
A blinded randomised controlled clinical trial with 3 groups include of 141 participants, that will be followed for one week and one mouth after education
Settings and conduct
the sampling method will be a multi-stage method. In the first step, 3 schools will be randomly selected from the first secondary school girls in the 4th district of Shiraz. Then, from selected schools, a class from each section is randomly selected as a cluster, and then individuals in each class will be selected by systematic randomization method. Selected individuals are randomly assigned to three groups of 47 participants by block randomization method.
Participants/Inclusion and exclusion criteria
Education of girls in secondary schools, Students and mothers willingness for participation in the study
Intervention groups
Intervention group 1: Puberty Health Education for girls
Intervention group 2: Puberty Health Education for mothers
Main outcome variables
Self esteem score from Cooper Smith questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037908N1
Registration date:2019-07-08, 1398/04/17
Registration timing:prospective
Last update:2019-07-08, 1398/04/17
Update count:0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Mitra Soltanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
soltanian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-25, 1398/07/03
Expected recruitment end date
2019-11-27, 1398/09/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the effects of puberty health education for girls and mothers on girl students’ self-esteem
Public title
A Comparison of the effects of puberty health education for girls and mothers on girl students’ self-esteem
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Education of girls in the first secondary schools
Students and mothers willing to participate in the study
Exclusion criteria:
History of taking sedative medications
Transfer to other school or city
Having a chronic disorder
Exposure to stressful incidents in the last three months
Age
From 13 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
141
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be a multi-stage method.
In the first step, 3 schools will be randomly selected from the first secondary school girls in the 4th district of Shiraz.
From selected schools, a class from each section is randomly selected as a simple cluster.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the training sessions will be conducted by the researcher, but the completion of the questionnaires will be done by the researcher-helper in three steps before the training, one week and one month after the training.
In other words, the outcome assessor and data analyzer are unaware of how the groups are allocated.
Placebo
Not used
Assignment
Parallel
Other design features
Initially, for each of the three groups, demographic and Cooper Smith Self Esteem Questionnaires will be filled in. Then, Puberty health classes will be held in 5 sessions with slideshows, giving pamphlets and lectures for intervention group one and two. Control group will not receive any training. For each of the three groups, Cooper Smith Self Esteem Questionnaire will be filled one week and one month later.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science, Zand Street
City
Shiraz
Province
Fars
Postal code
7194818694
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.SUMS.REC.1396.184
Health conditions studied
1
Description of health condition studied
Girls' self esteem
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-Esteem score from Cooper Smith Questionnaire
Timepoint
Before, one week and one month after education
Method of measurement
Cooper Smith self-esteem questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
3 sessions on puberty health education in the form of lectures, slideshows and pamphlets, each session will be held during 45 minutes for the intervention group 1 (girl students) in their schools.
Category
Lifestyle
2
Description
3 sessions on puberty health education in the form of lectures, slideshows and pamphlets, each session will be held during 45 minutes for the intervention group 2 (Mothers of girl students) in their schools.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
First secondary girl's schools in the Fourth District of Shiraz
Full name of responsible person
Mr. Allah Yar Rezaei
Street address
Education Department of the Fourth District of Shiraz, Vali-e-Asr Square ,Shiraz
City
Shiraz
Province
Fars
Postal code
14894-71368
Phone
+98 71 3224 2315
Fax
+98 71 3222 6034
Email
nahieh4@farsedu.ir
Web page address
http://shz4.farsedu.org/default.aspx
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice-Chancellor for Research & Technology - Seventh Floor - Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir/fa
Grant name
Research proposal budget
Grant code / Reference number
1396-01-08-15626
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Soltanian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz - Namazi Square - School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
Soltanian@sums.ac.ir
Web page address
http://nurs-midwif.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Soltanian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatemeh college of Nursing and Midwifery, Namazee square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
Soltanian@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Soltanian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatemeh college of Nursing and Midwifery, Namazi square, Shiraz
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
Soltanian@sums.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
No - There is not 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