Comparison of effect of family centered and individual nutrition education on decrease bodily signs of premensturation syndrom in daughters 14-18 years old
Comparison of effects of family centered and Individual nutrition education on bodily signs of premensturation syndrom in daughters 14-18 years old.
Design
Randomised, clinical trial with one control and two intervention groups design of 342 samples.
Settings and conduct
The place of study is 5 high schools in Qazvin. At schools, with using premenstruation questionnair, the students with premenstruation syndrom are recognized and based on inclusion and exclusion criteria114 students are putting as intervention group and 114 students are putting as control group and 114 students are putting as parents group. After doing nutrition education intervention to students and parents, we spread questionare form after 1 month and evaluate the result of education in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Have premenstruation syndrome,
Have regular and natural menstruation,
Not married,
14-18 years old,
Live in Qazvin,
Exclusion criteria:
Supplements usage,
Diseases,
History of cancer in family,
Have stress on three month ago,
Intervention groups
Intervention group 1: "students with premenstruation syndrom", convene 4 sessions education of self care of youth.
Intervention group 2:" families of students with premenstruation syndrom". convene 4 sessions education of self care of youth.
"Control group" students with premenstruation syndrom.There isnt any training.
Main outcome variables
Bodily signs of premenstruation syndrom, 24 hours nourishment recall .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180423039389N1
Registration date:2019-01-16, 1397/10/26
Registration timing:retrospective
Last update:2019-01-16, 1397/10/26
Update count:0
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Homa Javadiaftabdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 5521
Email address
h.javadiaftabdari@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of family centered and individual nutrition education on decrease bodily signs of premensturation syndrom in daughters 14-18 years old
Public title
Effect of nutrition education on Premensturation syndrom
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Have premensturation syndrom, based on premenstruation questionare.
Have regular and natural menstruation.
Be single.
Have 14-18 years old.
Live in Qazvin.
Be a student in one of schools in Qazvin.
Exclusion criteria:
Have diseases.
Take Supplements.
History of cancer in family
Have stress on three month ago such as; death of relatives, marriage and operation.
Age
From 14 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
342
Randomization (investigator's opinion)
Randomized
Randomization description
Stage 1:At first, Qazvin is considered as 5 cluster. Then from each cluster, one high school is selected in simple random that in average 5 high schools are selected.
Stage 2:The students who have moderate to severe premensturation syndrom are detected based on premenstruation questionnaire and exclusion and inclusion criteria.
Stage 3: Card shuffling with coloured cards is used for putting samples in three groups: "students", "families" and "control".
For randomize allocation, we provide 342 coloured cards such as yellow, blue and green that are separated in114 yellow cards, 114 green cards and 114 blue cards. Then after detecting students with premensturation syndrom (moderate to severe) one coloured card is given to her. After ending of allocate, students with yellow cards are ( intervention1), students with green cards are (intervention 2) and students with blue cards are Control group.
At last, 114 persons with yellow cards are in intervention group 1, 114 persons with green cards are in intervention group 2 and 114 persons with blue cards are in control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin university of medical sciences; Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Approval date
2018-05-20, 1397/02/30
Ethics committee reference number
IR.QUMS.REC.1397.045
Health conditions studied
1
Description of health condition studied
Premensturation Syndrom
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Bodily signs mark of premenstruation syndrom in premenstruation syndrom questionnaire.
Timepoint
Comparison of bodily signs of premenstruation syndrome before Intervention and 30 days after Intervention
Method of measurement
Premenstruation syndrom questionnaire.
2
Description
Nurishment score based on recall nurishment questionnaire.
Timepoint
Comparison recall nurishment before Intervention and 30 days after Intervention
Method of measurement
Recall 24 hours questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 :The nutrition trainingto parents of students with premensturation syndrom. The nutrition training is based on hygiene ministry protocol at 4 weeks at 40 minutes.
Category
Prevention
2
Description
Intervention group 2 : The nutrition training to students with premensturation syndrom. The nutrition training is based on hygiene ministry protocol at 4 weeks at 40 minutes with pamphelets.
Category
Prevention
3
Description
Control group: The Students with Premenstruation Syndrom. This group wont have any Education.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat high school
Full name of responsible person
Fateme Shali
Street address
No. 20, Aban Ave; Padegan Blvd.,
City
Qazvin
Province
Qazvin
Postal code
3413838451
Phone
+98 28 3333 3158
Email
Hamgam@pfm.ir
2
Recruitment center
Name of recruitment center
Nastaran high school
Full name of responsible person
Elham Haidari
Street address
No3; Day7 Ave., Dehkhoda Blvd
City
Qazvin
Province
Qazvin
Postal code
3414749996
Phone
+98 28 3378 3797
Email
Hamgam@pfm.ir
3
Recruitment center
Name of recruitment center
Alzahra School Of Art
Full name of responsible person
Masomeh Taromi
Street address
No10; Police Station side; Modarres Blvd
City
Qazvin
Province
Qazvin
Postal code
3413838451
Phone
+98 28 3323 5900
Email
SchoolAlzahra95@gmail.com
4
Recruitment center
Name of recruitment center
Narges
Full name of responsible person
Azam Mosavi
Street address
No 1, 1 alley, Dastghyb Ave.
City
Qazvin
Province
Qazvin
Postal code
3414749996
Phone
+98 28 3333 8322
Email
Hamgam@pfm.ir
5
Recruitment center
Name of recruitment center
Fatemiyeh
Full name of responsible person
Fatemah Hossieni
Street address
NaderiAve; Resalat Ave;
City
Qazvin
Province
Qazvin
Postal code
3414749996
Phone
+98 28 3333 5995
Email
Hamgam@pfm.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pymani
Street address
Qazvin University of Medical Sciences ; Shahid Bahonar Blvd; Qazvin.
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Homa Javadi Aftabdari
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.39; 8th Sadra Ave; West Mollasadra Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415835995
Phone
+98 28 3368 5521
Email
h.Javadiaftabdari@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Homa Javadi
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 39; 8th Sadra Ave; West Sadra Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415835995
Phone
+98 28 3368 5521
Email
h.Javadiaftabdari@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Homa Javadi
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.39; 8th Sadra Ave ; West Mollasadra Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415835995
Phone
+98 28 3368 5521
Email
h.Javadiaftabdari@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There isn't more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
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