The aim of this study is to measure impact of using the earmuff on physiologic and dynamic responses of premature infants. Main inclusions criteria are gestational age over 28 weeks and under 37 weeks and, and absence of auditory and congenital disorders and principal exclusion criteria are discharging of neonate during using muff and disagreement of parents of participate in study. Premature neonates admitted in Beheshti hospital neonatal intensive care unit with inclusion criteria are sample of the study. All participants were divided in to two groups randomly 32 in each group. The group receiving earmuff intervention was compared to the control group receiving only routine care. In this clinical trial earmuffs were placed over the premature neonate’s ears 2 hours in the morning and evening for 2 days in row to reduce noise intensity in the busiest time of neonatal intensive care unit. Using of earmuff reduce the noise intensity and will make better environment for them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092010812N2
Registration date:2012-10-16, 1391/07/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-16, 1391/07/25
Registrant information
Name
Zahra Abdeyazdan
Name of organization / entity
Isfaha University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2908
Email address
marofi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
research center of Isfahan University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effects of earmuff on physiologic and dynamic responses of premature neonates admitted in neonatal intensive care unit at 2012
Public title
Using earmuff for premature infant
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: GA more than 28 weeks and less than 37 weeks; neonates without hearing loss or any difficult on middle and external ear; no congenital problems; Apgare score more than 7; in neonate with acute respiratory distress syndrome haveing score less than 5 exclusion criteria: neonate discharge of neonatal intensive care unit; acute respiratory distress syndrome
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Unevrsity of Medical Siences
Street address
Isfaha University of Medical Siences, Hezargarib st, Isfahan
City
Isfahan
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
390623
Health conditions studied
1
Description of health condition studied
prematurity
ICD-10 code
P07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation. Prematurity NOS
Primary outcomes
1
Description
physiologic responsess
Timepoint
3 hours in the morning and 3 hours in the evening for 2 days in row every 15 minutes bigining 15 minute before the study and will continue 1 houre after remove the muff
Method of measurement
bservation
2
Description
dynamicl responsess
Timepoint
3 hours in the morning and 3 hours in the evening for 2 days in row every 15 minutes bigining 15 minutes befor of using ear muff and will continue until 1 hours after the remove the muff
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
earmuff will place over the premature infants ear in trial group 2 hours in the morning and 2 hours in the evening for 2 days
Category
Other
2
Description
only routine care in neonate admitted in control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti hospital
Full name of responsible person
Sara Ghassemi
Street address
shahid Beheshti Hospital, Shahid Beheshti st.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mis Keyanpour
Street address
Isfahan University of Medical Sciences, Hezargarib st, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Marofi
Position
Academic member of Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2908
Fax
Email
marofi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfaha university of medical siences
Full name of responsible person
Zahra Abdeyazdan
Position
assistant professor
Other areas of specialty/work
Street address
Isfaha university of medical siences
City
Isfahan
Postal code
Phone
+98 31 1792 2908
Fax
Email
abdeyazdan@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Sara Ghassemi
Position
master nursing student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1375 1517
Fax
Email
s.ghassemi29@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)