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IRCT20171015036779N2 IRCT 2018-02-11 Oroumia University of Medical Sciences Effect of stress on thyroid hormones Assessment of changes in thyroid hormones and iodine in urine with mild and short-term social stress in male and female students in Urmia 2018-04-13 anticipated 160 Complete https://irct.ir/trial/27401 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, 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 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. N/A endocrine and metabolic. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Personal information is confidential and should not be published
public Ehsan Saboory
Department of physiology, faculty of medicne,Serow road
Urmia Iran (Islamic Republic of) 5756115111 +98 44 3277 0698 saboory@umsu.ac.ir Oroumia University of Medical Sciences scientific Ehsan saboory
Department of physiology, faculty of medicne, Serow road
Urmia Iran (Islamic Republic of) 5756115111 +98 44 3277 0698 saboory@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) students at grade 4 to 6 in elementary schools without any recognized illness and drug application 9 years 12 years Both 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 Behavior Behavior 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. 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. Thyroid hormones. Timepoint: before stress and two hours after it. Method of measurement: ready to use Eliza kit. Urinary iodine concentration. Timepoint: before and after stress. Method of measurement: ready to use ELIZA kit. Heart rate. Timepoint: before and after stress. Method of measurement: counting the heart beat in one minute. Blood pressure. Timepoint: before and after stress. Method of measurement: sphygmomanometer. Oroumia University of Medical Sciences Approved 2017-09-20 Ethics committee of Urmia university of medical sciences Blv resalat, End of Jehad street, next to emergency centerUrmia Urmia West Azarbaijan Iran (Islamic Republic of)