The aim of this crossover clinical trial is to compare acute effect of musical and industrial sound exposure on blood pressure and heart rate. The subjects will be chosen from 20- 40 aged volunteer men with normal blood pressure and hearing. Subjects with diabetes, antihypertensive drug use or any other condition that can affect blood pressure and/or heart rate will be excluded from the study. Subjects will be assigned randomly (balanced block Randomization) into one of two groups. Each group will be exposed in a cross-over manner either to industrial noise (90dBA textile industry noise) or light music (90dBA love is blue music sound). During exposure time, systolic and diastolic blood pressure and heart rate will be monitored.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811143269N1
Registration date:2010-04-24, 1389/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
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 and Health Services, Vice chancellor for Research
Expected recruitment start date
2010-04-20, 1389/01/31
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of acute industrial noise effects on blood pressure and heart rate in comparison with musical sound
Public title
Industrial noise and music sound effects on blood pressure and heart rate; a randomized trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: volunteer men aged 20-40 with normal blood pressure and normal hearing (verified with eudiometry).
Exclusion criteria: Consumption of anti hypertensive medication, history of cardiovascular disease or diabetes mellitus, caffeine intake within 1h before baseline measurement, smoking in 15 minutes before baseline measurement, external adrenergic stimulant consumption (such as intra nasal decongestant) and inadequate sleep during previous night
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
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences and Health Services
Street address
Tehran University of Medical Sciences and Health Services, Poorsina street. Tehran
City
Tehran
Postal code
Approval date
2010-01-22, 1388/11/02
Ethics committee reference number
6338
Health conditions studied
1
Description of health condition studied
blood pressure and heart rate
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood Pressure
Timepoint
Every 5 minute during exposure
Method of measurement
by digital sphygmomanometer OMRON 907
2
Description
heart rate
Timepoint
Every minutue during exposure
Method of measurement
by digital sphygmomanometer OMRON 907
Secondary outcomes
1
Description
Hearing transient Threshold Shift
Timepoint
just before and after exposure
Method of measurement
audiometery
Intervention groups
1
Description
15 minute exposure with 90dBA music sound in control group
Category
Other
2
Description
15 minute exposure with 90dBA industrial noise in intervention group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Gholamreza Pouryaghoub
Street address
Baharloo Hospital. Rah Ahan Squ.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Deputy of Research
Street address
Tehran University of Medical Sciences, Porsina Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
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
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Gholamreza Pouryaghoub
Position
Occupational Medicine Specialist/ Faculty Member
Other areas of specialty/work
Street address
Occupational Medicine Department, School of Medicine, Tehran University of Medical Sciences and Health Services
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
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Gholamreza Pouryaghoub
Position
Occupational Medicine Specialist,
Other areas of specialty/work
Street address
Occupational Medicine Department. School of Medicine,Tehran University of Medical Sciences and Health Services
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
Tehran University of Medical Sciences and Health Servises
Full name of responsible person
Gholamreza Pouryaghoub
Position
Occupational Medicine Specialist/Faculty Member
Other areas of specialty/work
Street address
Occupational Medicine Department, School of Medicine, Tehran University of Medical Sciences and Health Servises
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)