The present study was designed to evaluate the effect of traffic noise on salivary bio-markers while driving activity was ongoing. In order to implement the project we employ male students who have driving license and also driving experience. We ask these people to stay on a car that is capable to simulate driving activity and drive with it for an hour. During driving, in the laboratory we will display the recorded traffic noise with sound average level of 75 dBA. As the previous studies showed that noise can release stress hormones in body, thus in this study in order to deliberate the effect of noise on people performance, effect of noise on stress hormones , such as cortisol and alpha amylase will be checked. This means that the level of these hormones once before and once after testing by individuals,will be measured to determine the effect of noise on hormone levels.
In this study we use salivary cortisol and alpha-amylase kits to collect samples once before and once after driving activity and the samples will send to the laboratory for analysis.
Sample size is 56 persons for cortisol and alpha amylase and these people in each stages of study can leave this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110424875N1
Registration date:2016-01-12, 1394/10/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-12, 1394/10/22
Registrant information
Name
Iraj alimohammadi
Name of organization / entity
iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 7939
Email address
alimohamadi.i@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental sources of Iran University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the traffic noise effect on saliva cortisol and alpha amylase during driving activity
Public title
Effect of traffic noise on saliva cortisol and alpha amylase during driving
Purpose
Prevention
Inclusion/Exclusion criteria
Healthy men; aged between 18 to 35 years old; without any underlying disease and medicine consumption or smoke; having driving licence and driving experience; fill the form of participating in the project
exclusion criteria:
Unwillingness to continue cooperation
Age
From 18 years old to 35 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran, Tehran, Hemmat highway, Next to Milad Hospital, Iran University of Medical Science
City
Tehran
Postal code
Approval date
2015-09-22, 1394/06/31
Ethics committee reference number
IR.IUMS.REC.1394.26225
Health conditions studied
1
Description of health condition studied
The effect of traffic noise on secretion of cortisol and alpha amylase
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
saliva level of cortisol
Timepoint
during experiments before samples be exposed with recorded traffic noise and doing driving activity
Method of measurement
by cortisol and alpha amylase kits
Secondary outcomes
1
Description
level of saliva alpha amylase
Timepoint
after finishing each level of experiment
Method of measurement
by cortisol and alpha amylase kit
Intervention groups
1
Description
In order to determining the effects of noise on stress hormones, people will expose to recorded traffic noise during driving activity. The levels of stress hormones such as cortisol and alpha amylase, as stress index before and after doing experiments will be measured.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Iraj Almohammadi
Street address
Iran, Tehran, Hemmat highway, Next to Milad Hospital, Iran University of Medical Science
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research manager of Iran University of Medical Science
Full name of responsible person
Dr Naserbakht
Street address
Iran, Tehran, Hemmat highway, Next to Milad Hospital, Iran University of Medical Science
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research manager of Iran University of Medical Science
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
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Iraj Alimohamadi
Position
Faculty member
Other areas of specialty/work
Street address
Iran, Tehran, Hemmat highway, Next to Milad Hospital, Iran University of Medical Science
City
Tehran
Postal code
Phone
+98 21 8860 7946
Fax
Email
alimohamadi.i@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Iraj alimohamadi
Position
PhD
Other areas of specialty/work
Street address
Iran, Tehran, Hemmat highway, Next to Milad Hospital, Iran University of Medical Science
City
Tehran
Postal code
Phone
+98 21 8860 7946
Fax
Email
alimohamadi.i@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Iraj Alimohamadi
Position
Faculty member
Other areas of specialty/work
Street address
Iran, Tehran, Hemmat highway, Next to Milad Hospital, Iran University of Medical Science
City
Tehran
Postal code
Phone
+98 21 8860 7946
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)