Protocol summary

Summary
Physical factors such as noise, heat and lightind along side other enviromental factors can cause changes in occupational performance and social behavior (increased errors, accident and reduced product quality). The aim of This study is Investigation the effects of combined exposure to harmful and non-harmful levels of noise, heat and lighting on performance indices such as attention & working memory and physiological indices such as body temperature, blood pressure & heart rate of human, 2013. This study is an interventional. student with having the general health, hearing,vision,No consumption of Narcotics and full satisfaction will participate in the study. Noise, heat and lighting at two levels harmful and non harmful together are combined, and the 8 combination conditions are created. Each group exposed to one of 8 conditions placed. Attention, working memory and physiological parameters(pulse, blood pressure and temperature) of each person is measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013101415016N1
Registration date: 2014-04-23, 1393/02/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-23, 1393/02/03
Registrant information
Name
Zahra Zamanian
Name of organization / entity
Shiraz University of Medical Sciences, School of Public Health
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
zamanianz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effects of combined exposure to harmful and non-harmful levels of noise, heat and lighting on performance indices such as attention & working memory and physiological indices such as body temperature, blood pressure & heart rate of human, 2013.
Public title
Investigation the effects of combined exposure to harmful and non-harmful levels of noise, heat and lighting on performance indices such as attention & working memory and physiological indices such as body temperature, blood pressure & heart rate of human, 2013.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: having the general health, hearing, vision, and no consumption of Narcotics and full satisfaction for participation in the study.
Age
From 18 years old to 26 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
zand st,shiraz
City
shiraz
Postal code
Approval date
2013-10-08, 1392/07/16
Ethics committee reference number
CT-92-6710

Health conditions studied

1

Description of health condition studied
Attention
ICD-10 code
F73
ICD-10 code description
Profound mental retardation

2

Description of health condition studied
Memory
ICD-10 code
R41
ICD-10 code description
Other symptoms and signs involving cognitive functions and awareness

3

Description of health condition studied
Blood pressure
ICD-10 code
Z01.3
ICD-10 code description
Examination of blood pressure

4

Description of health condition studied
Body temperature
ICD-10 code
ICD-10 code description

5

Description of health condition studied
Heart rate
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
reaction time
Timepoint
during exposure
Method of measurement
Continuous Performance Test

2

Description
commission error
Timepoint
during exposure
Method of measurement
Continuous Performance Test

3

Description
omission error
Timepoint
during exposure
Method of measurement
Continuous Performance Test

4

Description
working memory
Timepoint
during exposure
Method of measurement
pasat test

5

Description
blood pressure
Timepoint
before, during & after exposure
Method of measurement
digital manometer

6

Description
heart rate
Timepoint
before, during & after exposure
Method of measurement
digital manometer

7

Description
body temperature
Timepoint
before, during & after exposure
Method of measurement
mercury thermometer

Secondary outcomes

1

Description
Personality Type
Timepoint
before exposure
Method of measurement
NEO Questionnaire

Intervention groups

1

Description
combined exposure to noise, temperature and lighting(8 different conditions).
Category
Other

2

Description
group1:exposure to noise(55 db),lighting(500lux),heat(24ᵒc) for 40 min.
Category
Other

3

Description
group2:exposure to noise(55 db),lighting(20lux),heat(24ᵒc) for 40 min.
Category
Other

4

Description
group3:exposure to noise(55 db),lighting(500lux),heat(32ᵒc) for 40 min.
Category
Other

5

Description
group4:exposure to noise(55 db),lighting(20lux),heat(32ᵒc) for 40 min.
Category
Other

6

Description
group5:exposure to noise(95 db),lighting(500lux),heat(24ᵒc) for 40 min.
Category
Other

7

Description
group6:exposure to noise(95 db),lighting(20lux),heat(24ᵒc) for 40 min.
Category
Other

8

Description
group7:exposure to noise(95 db),lighting(500lux),heat(32ᵒc) for 40 min.
Category
Other

9

Description
group5:exposure to noise(95 db),lighting(20lux),heat(32ᵒc) for 40 min.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Laboratory of occupational health, School Public Health
Full name of responsible person
Fateme Amiri
Street address
School Public Health, Koi Zahra
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Syyed Basir Hashemi
Street address
Shiraz University of Medical Sciences ,zand st,shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
School of Public Health, Shiraz
Full name of responsible person
Zahra Zamanian
Position
PhD, Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
School of Public Health, Shiraz, Koi Zahra
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
zamanianz@sums.aac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health, Shiraz
Full name of responsible person
Fatemeh Amiri
Position
MSc student
Other areas of specialty/work
Street address
School of Public Health, Koi Zahra
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
amiri_fa@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Fateme Amiri
Position
Other areas of specialty/work
Street address
School of Public Health, Shiraz, Koi Zahra
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
amiri_fa@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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