Protocol summary

Summary
The aim of this study was to comparison of effect of puberty health education to mothers and to daughters on girls’ knowledge and performance in high schools of Tabriz. Design: single-blind randomized controlled trial. The sample size was calculated for each group is 110. Participants: 330 adolescent girls between 13 to 14 years old who experienced at least 6 months after the first menstrual period, who studying in seventh and eighth graders secondary girls' schools of Tabriz and 110 theirs mother. Stratified random sampling will be used for sampling. In first stage, 15 schools will be randomly selected from Tabriz schools from the five areas of education of Tabriz. Then, from each school, 25 students (from seventh and eighth grades) will be randomly selected. After acquiring informed consent from students and your parents, pre-test questionnaires will be completed by participants. Then, according to the similarity of the performance score of pre-test, 15 schools will be divided into 5 groups which contain 3 schools in each group. These 3 schools in each group will be randomly assigned to two intervention groups (education to mothers and to daughters) and one control group. The two intervention groups will receive training. Training includes lecture presentation and booklet. The control group will receive no intervention. Main outcome measures: Knowledge, attitude and performance that will be measured by self-report in all three groups before and one month after education by students.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201408244613N11
Registration date: 2014-09-05, 1393/06/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-09-05, 1393/06/14
Registrant information
Name
Sousan Valizadeh Dehkharghani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
009804134751706- 34796770
Email address
valizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparion of Effect of Puberty Health Education to Mothers and Daughters on Girls’ Knowledge and Performance in High Schools of Tabriz:Single Blind Randomized Clinical Trial
Public title
Comparion of Effect of Puberty Health Education to Mothers and Daughters on Girls’ Knowledge and Performancein High Schools of Tabriz
Purpose
Prevention
Inclusion/Exclusion criteria
A girl student: 14-13 years of age 1. (2) passing at least 6 months from the time period, according to their 3 having a chronic illness, physical or mental 4 girls studying at public and private high schools in Tabriz. 5 schoolgirls informed consent to participate in the study. 6 girls who live with their real mothers B mothers: 1 mom real girls 2 having the lowest literacy to read and write 3 having a chronic illness, physical or mental 4 Not taking certain medications (anti-anxiety drugs, sedatives, anticonvulsants) Consent 5. 6 non-working mothers in the Health Professions
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: 330
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences, Vice chancellor for research
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Postal code
51668-44199
Approval date
2014-08-18, 1393/05/27
Ethics committee reference number
9381

Health conditions studied

1

Description of health condition studied
Puberty hygiene
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Knowledge
Timepoint
Before and one month after education
Method of measurement
Knowledge questionnaire

2

Description
Performance
Timepoint
Before and one month after education
Method of measurement
Performance questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Education through educational booklet containing the training materials in the field of mental health (skin and hair, menstruation, physical activity, and resting and feeding), psychosocial maturity, and lectures on the content of the manual is a high school girls.
Category
N/A

2

Description
Education through educational booklet containing the training materials in the field of mental health (skin and hair, menstruation, physical activity, and resting and feeding), psychosocial maturity, and talk to the mothers of female students is based on the contents of the manual
Category
N/A

3

Description
Control group will receive no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Girls' state and non state High Schools in Tabriz
Full name of responsible person
Afsari Atusa
Street address
South Artesh street, Education Office
City
Tabriz East Azerbaijan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Shakouri Seyyed Kazem
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Sousan Valizadeh
Position
PhD in Nursing
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street Tabriz
City
Tabriz
Postal code
51668-44199
Phone
+98 41 3477 0648
Fax
+98 41 3479 6969
Email
valizadehsousan13@gmail.com, valizades@tbzmed.ac.ir
Web page address
http://researchvice.tbzmed.ac.ir

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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