This study aimed to investigate changes of T3 and iodine concentrations in urine of elementary students following a mild and short-term social stress in Urmia city.
Design
In this study, 160 students from both sexes (80 girls and 80 boys) will randomly be chosen. A mild and short-term social stress will be applied to half of the students. Before and after stress, urine sample will be collected and T3 and Iodine concentrations will be determined. Also, heart rate and blood pressure will be measured before and after stress.
Settings and conduct
This study will be done in elementary schools of Danesh and Setayesh in Urmia city with presence of students' family.
Participants/Inclusion and exclusion criteria
Inclusion criteria: students in grade 4 to 6 without any recognized illness and drug usage that they and their families are volunteers to participate in the study.
Exclusion criteria: Students who have had a major family problem in the last two months, such as parental divorce, the death of one of the parents, and the death of the first grade relative.
Students who have had severe illness in the past month and endorsed by our endocrinologist or psychiatrist colleagues.
Students who do not have normal physical growth, such as dwarfs and giants
Intervention groups
control group will be studied without exposure to stress. group stress will be exposed to a mild and short term stress. The both groups will be studied before and after, also.
Main outcome variables
heart rate; blood pressure; stress score; T3 and iodine concentration in urine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171015036779N2
Registration date:2018-02-11, 1396/11/22
Registration timing:prospective
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Ehsan Saboory
Name of organization / entity
Urmia U of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 32780803
Email address
saboory@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia university of medical sciences
Expected recruitment start date
2018-04-13, 1397/01/24
Expected recruitment end date
2018-05-25, 1397/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of changes in thyroid hormones and iodine in urine with mild and short-term social stress in male and female students in Urmia
Public title
Effect of stress on thyroid hormones
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
students at grade 4 to 6 in elementary schools without any recognized illness and drug application
Exclusion criteria:
students who had a certain family problem in the last two months such as separation of parents, the death of mother or father, the death of relatives of first degree
student who had a sever illness in the last month diagnosed by endocrinologist and psychiatric colleagues
students who have not normal growth such as dwarfs and giants
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate 80 students to the intervention groups, we will use a random block method .We will use blocks of size 4. This method of randomization will yield balance number of students in two groups. The blocks and their random order are defined before the random selection of students, and will be concealed among on the research team members.
At each elementary school, list of all students of fourth, fifth and sixth grade are obtained from school officials. Then, we will give an identification number from 1 to N to each student. Then, using a random number table, 100 students will be selected from each school (i.e., students will be randomly selected from the school). (We consider a 20% chance of not agreeing to participate in the study by the students’ parents) .The selection order of the students will be recorded. After obtaining the informed consent from the parents of the students, we will match the selection order of the students with the predefined order of the blocked randomization to identify the group that the students will enter to it
Blinding (investigator's opinion)
Single blinded
Blinding description
students will be divided into two groups as group one and group two. the students and their teachers are not informed of the group differences.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia university of medical sciences
Street address
Blv resalat, End of Jehad street, next to emergency centerUrmia
City
Urmia
Province
West Azarbaijan
Postal code
5556115111
Approval date
2017-09-20, 1396/06/29
Ethics committee reference number
IR.UMSU.REC.1395.435
Health conditions studied
1
Description of health condition studied
endocrine and metabolic
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Thyroid hormones
Timepoint
before stress and two hours after it
Method of measurement
ready to use Eliza kit
2
Description
Urinary iodine concentration
Timepoint
before and after stress
Method of measurement
ready to use ELIZA kit
Secondary outcomes
1
Description
heart rate
Timepoint
before and after stress
Method of measurement
counting the heart beat in one minute
2
Description
blood pressure
Timepoint
before and after stress
Method of measurement
sphygmomanometer
Intervention groups
1
Description
stress group: In the morning at 9 heart rate and blood pressure of the students will be recorded and urine sample will be obtained.Reading and presenting one page text from student's Farsi book in each grade in front of researchers, teachers and staff of the school will be performed by the students. This is conceptualized as mild social stress. two h later recording of heart rate and blood pressure and obtaining urine sample will be repeated.
Category
Behavior
2
Description
Control group: the students will be studied without any intervention. At 9 am heart rate and blood pressure of the students will be recorded and urine sample will be obtained. the procedure will be repeated 120 minutes later.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Elementary school Setayesh
Full name of responsible person
Narges Norooz Tamar
Street address
Next to Baba taher street, Sadi street
City
Urmia
Province
West Azarbaijan
Postal code
5719187497
Phone
+98 44 3367 4330
Email
ehsan.db@gmail.com
2
Recruitment center
Name of recruitment center
elementary school Danesh
Full name of responsible person
Roghayeh Moradi
Street address
Next to Baba taher street, Sadi street
City
Urmia
Province
West Azarbaijan
Postal code
5719166943
Phone
+98 44 3368 6130
Email
ehsaan48@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
End of Jihad street, Resalat BLdv
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3222 2010
Email
malizade1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Ehsan Saboory
Position
Prof in physiology, academic member
Latest degree
Ph.D.
Other areas of specialty/work
neuroendocrinology
Street address
Department of physiology, faculty of medicne,Serow road
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3277 0698
Fax
Email
saboory@umsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ehsan saboory
Position
PhD in physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Department of physiology, faculty of medicne, Serow road
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3277 0698
Fax
Email
saboory@umsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ehsan Saboory
Position
professor in physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Department of physiology, school of medicine, Serow road
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3277 0698
Email
saboory@umsu.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
Personal information is confidential and should not be published