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A clinical trial on the effect of education and the presence of visual signs on the intensity of noise pollution induced by the neonatal intensive care unit staff

Protocol summary

Summary
The purpose of this study was to investigate the effect of behavioral education on the intensity of noise induced by the staff working in the neonatal intensive care unit. The population included all the personnel of the neonatal intensive care unit of Valiasr Hospital in Birjand. Twenty-five personnel of this department were incorporated by census. The study was one-grouped, without blindness, and without randomization. The main criteria for inclusion in the study comprised of the working staff in the neonatal intensive care unit of Valiasr Hospital in Birjand and informed consent for participation. Major exclusion criterion was transference from the neonatal intensive care unit. In this study, the neonatal intensive care unit was divided into 4 points at the bedside of the infants and inside the incubator, and 4 points in the center of the ward, inside the incubator, and in the nursing station. In each area, the intensity was measured for at least 15 minutes during each work shift for two days. Subsequently, a general meeting was held for all staff members of the neonatal department including physicians, nurses and sanitation crew to explain about the sources of noise pollution and the methods of noise suppression. After a week, noise intensity was measured again in all stations. In the next step, color flags associated with noise absorption project and the related posters were installed and noise intensity was measured. To determine noise intensity, the maximum sound level, mid-level and minimum sound level were recorded for 15 minutes using the TES-1385 sound pressure detector device.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017101117756N32
Registration date: 2017-10-22, 1396/07/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-22, 1396/07/30
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research, Birjand University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on the effect of education and the presence of visual signs on the intensity of noise pollution induced by the neonatal intensive care unit staff
Public title
The effect of education and visual signs on noise pollution
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Staff of neonatal intensive care unit of Valiasr Hospital of Birjand; informed consent for participation in the study. Exclusion criteria: Transference of the staff member from the neonatal intensive care unit.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice-chancellery of Research, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2017-02-01, 1395/11/13
Ethics committee reference number
Ir.bums.REC.1395.235

Health conditions studied

1

Description of health condition studied
Noise pollution
ICD-10 code
W42
ICD-10 code description
Exposure to noise

Primary outcomes

1

Description
Noise intensity in the environment
Timepoint
Before and one week after intervention
Method of measurement
TES-1385 Sound Pressure Detector made by TES Company in Taiwan

Secondary outcomes

empty

Intervention groups

1

Description
intervention Group (Education): A general meeting was held for all staff members of the neonatal department including physicians, nurses and sanitation crew to explain about the sources of sound pollution and the methods of noise suppression. Moreover, color flags associated with noise absorption project and the related posters were installed in the ward.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit
Full name of responsible person
Dr Gholamreza Faal
Street address
Valiasr Hospital, Ghaffari St.,
City
Birjand,

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellery for Research and Technology, Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Vice-chancellery of Reasearch and Technology, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery for Research and Technology, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr Afsaneh Davoodi
Position
Assistant of Pediatrics
Other areas of specialty/work
Street address
Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
afsanehdavodi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Gholamreza Faal
Position
Associate Professor of Pediatrics
Other areas of specialty/work
Street address
Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3242 5402
Fax
Email
faalgh1@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Vice-chancellery of Education, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
hadirooz@gmail.com
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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