To evaluate the saliva cortisol level response to stress effect of noise exposure, with respect to inclusion and exclusion criteria 100 volunteers will be introduced to study. They will be allocated to intervention and control groups randomly using balanced block randomization method. After saliva sampling (before intervention sample) intervention group will experience 20 minute exposure to 90 dB industrial noise (controlled with SLM) in sitting position without any physical activity in a controlled room. Control group will experience same condition without noise exposure. After this period second saliva sampling will be down. Finally saliva cortisol alternation will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111163269N2
Registration date:2011-12-11, 1390/09/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-12-11, 1390/09/20
Registrant information
Name
Gholamreza Pouryaghoub
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 5588
Email address
pourya@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Deputy of Research
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining saliva cortisol level response to noise exposure in a RCT study
Public title
stress responses to noise exposure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: male gender; normal hearing;
Exclusion criteria: age lower than 20 or higher than 40 years; cardiovascular diseases; diabetes; alcohol consumption; Hypertension; food consumption during 2hr before sampling; tea or cafe consumption during 30 minute before sampling; smoking during 30 minute before sampling; use of drugs that can alter corticosteroids secretion; previous night sleep deprivation; sport activity before sampling
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Deputy of Research, Tehran University of Medical Sciences
Street address
Enqelab Square, Qods Avenue, Tehran University of Medical Sciences Central Office
City
Tehran
Postal code
Approval date
2010-11-07, 1389/08/16
Ethics committee reference number
1085/130/ص/89
Health conditions studied
1
Description of health condition studied
saliva cortisole increase
ICD-10 code
Z57.0
ICD-10 code description
occupational noise exposure
Primary outcomes
1
Description
saliva cortisol increase
Timepoint
just before and after intervention
Method of measurement
using saliva cortisol dimetra kit
Secondary outcomes
empty
Intervention groups
1
Description
Exposure to 90 dB recorded industrial noise for a 20 minute interval without any physical activity at sitting position in a controlled room for intervention group.
Category
Other
2
Description
sitting in a controled room for 20 minute without any physical activity (same experience as intervention group) without noise exposure.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo Haspital
Full name of responsible person
Gholamreza Pouryaghoub
Street address
Tehran Rah Ahan Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Thran University of Medical Scienses
Full name of responsible person
Deputy of Research
Street address
Enqelab Square, Qods Avenue, Tehran University of Medical Sciences Central Office, Deputy of Research
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Thran University of Medical Scienses
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
Center for Research on Occupational Diseseas
Full name of responsible person
Gholamreza Pouryaghoub
Position
Occupational medicine specialist
Other areas of specialty/work
Street address
Center for Research on Occupational Diseases, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6640 5588
Fax
Email
pourya@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center for Research on Occupational Diseases
Full name of responsible person
Gholamreza Pouryaghoub
Position
Occupational medicine specialist
Other areas of specialty/work
Street address
Center for Research on Occupational Diseases, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6640 5588
Fax
Email
pourya@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Center for Research on Occupational Diseases
Full name of responsible person
Gholamreza Pouryaghoub
Position
Occupational medicine specialist
Other areas of specialty/work
Street address
Center for Research on Occupational Diseases, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6640 5588
Fax
Email
pourya@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)