purpose: evaluate effectiveness of earmuff on the physiologic and behavioral responses in preterm infants. The study population: premature infant less than 37 gestational age. inclusion criteria: preterm infant, age more than 7 day, need to care in incubator, without congenital ear infections and other congenital anomaly. exclusion criteria: infant death, life threatening emergency condition. study sample size 36 infants. methods: a crossover study comprising 36 clinically preterm infant less than 37 gestational age cared in closed incubator was conducted. preterm infant acted as their own controls whereby they were observed without earmuff(group 1) for 1 day and with earmuff(group2) on consecutive 1 day. preterm infants physiologic responses such as blood pressure, body temperature, respiratory rate, heart rate, oxygen saturation and Anderson behavioral state scoring system scores were assessed over 30 s every 2 hour for 8 h during daytime for 2 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020817972N6
Registration date:2015-05-17, 1394/02/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-17, 1394/02/27
Registrant information
Name
Zahra Godarzi
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4407
Email address
godarziz@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research Tehran University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of earmuffs on the physiologic and behavioral responses in preterm infants
Public title
the effect of earmuff on the preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: preterm infant, age more than 7 day, need to care in incubator, normal audiometry, oral nutrition, no needs to use Anticonvulsants and Respiratory stimulant drugs, without congenital ear infections and other congenital anomaly, The absence of hemodynamic instability during the first week after birth, without intra ventricular hemorrhage, exclusion criteria: infant death, life threatening emergency condition, refuse parents to participate in the study
Age
From 8 days old to 29 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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 in research Tehran University Of Medical Sciences
Street address
Room 501، Fifth Floor، Medical Ethics and History of Medicine Reserch Center، Junction of Qhods st and Keshavarz Boulvard
City
tehran
Postal code
Approval date
2014-03-15, 1392/12/24
Ethics committee reference number
7659
Health conditions studied
1
Description of health condition studied
preterm infant
ICD-10 code
p07
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.
Primary outcomes
1
Description
respiratory rate
Timepoint
Q2h with earmuff and without earmuff
Method of measurement
respiratory rate per min measured by monitor
2
Description
heart rate
Timepoint
Q2h with earmuff and without earmuff
Method of measurement
heart rate per min measured by monitor
3
Description
oxigen saturation
Timepoint
Q2h with earmuff and without earmuff
Method of measurement
with palsoximeter
4
Description
body tempreture
Timepoint
Q2h with earmuff and without earmuff
Method of measurement
santigrade degree
5
Description
sistolic blood presure
Timepoint
Q2h with earmuff and without earmuff
Method of measurement
mmhg
6
Description
diastolic blood presure
Timepoint
Q2h with earmuff and without earmuff
Method of measurement
mmhg
7
Description
behavioral response
Timepoint
Q2h with earmuff and without earmuff
Method of measurement
abss score system
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: one day preterm infant with earmuff and one day without earmuff
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Aliasghar Hospital
Full name of responsible person
Doctor Nasrin Khalesi
Street address
Zafar Street، Aliasghar Hospital.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research Tehran University Of Medical Sciences
Full name of responsible person
Dr Masoud Yunesian
Street address
Room 604، Sixth Floor، Central Organization Of Tehran University Of Medical Sciences، Qhods St، Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Siences School Of Nursing And Midwifery
Full name of responsible person
Zahra Godarzi
Position
Faculty Member of Nursing School
Other areas of specialty/work
Street address
Eastern Nosrat St، Doctor Mirkhani St، Tohid Square
City
Tehran
Postal code
Phone
00
Fax
Email
godarziz@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
Azadeh Ranjbar
Position
Student Of Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Haghgoo Avenue، Shishegaran Street.
City
Lahijan
Postal code
4418744871
Phone
+98 13 4223 6735
Fax
Email
ranjbarazadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)