this is a semiexperimental study with repeated measurments for evaluation of taped maternal voice on physiologic responce in their neonates. The duration of study is three consequative days. The populatin are selected by inclusion and exclusion criteria ( neonate who not receiving respiratory support , oxygen and cardiotonic drug).30 neonates admitted in shariati hospital NICU who at least are 2 days old ;in addition to routine care ,recieve their taped maternal sound 3 times per day for 3 days. the duration of intervention is 15 min in each times.at the first 5 min we collect basal data and then in second 5 min the sound of mother report and then at the last 5 min we continue monitoring of vital sign. The intensity of sound is below 50 decible.The collected data are Respiratory rate ,heart rate and o2 saturation .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111268199N1
Registration date:2012-03-08, 1390/12/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-08, 1390/12/18
Registrant information
Name
Negar Sajjadian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2541
Email address
nsajadian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of maternal sound on neonatal vital signs in preterms admitted in NICU
Public title
Evaluation of maternal sound on neonatal physiologic response in preterms admitted in NICU
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:
gestetional age 32-34;post natal age more than 2 day of old;no congenital or neurologic abnormality;no asphyxia;
exclusion criteria:history of maternal addiction;any need to respiratory support
intraventricular hemorrhage more than grade 2;history of any cardiotonic agent or muscle relaxant usage for neonate; metabolic disease;any neonatal bacterial ,viral or fungal infection;paternal disagrrement to continue study
Age
From 1 year old to 28 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Tehran University Of Medical Sciences
Street address
Keshavarz Blv , Tehran
City
Tehran
Postal code
Approval date
2012-02-01, 1390/11/12
Ethics committee reference number
45152
Health conditions studied
1
Description of health condition studied
Evaluation of maternal sound on neonatal phsiologic responces in preterms admitted in NICU ward
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
respiratory rate
Timepoint
at the end of every 5 min of intervention
Method of measurement
respiratory rate measurment by researcher aid
2
Description
heart rate
Timepoint
at the end of every 5 min of int
Method of measurement
by cardiorespiratory manitor
3
Description
o2 saturation measurment
Timepoint
at the end of every 5 min of intervention
Method of measurement
by pulse oximetry
Secondary outcomes
1
Description
gestetional age
Timepoint
at birth time
Method of measurement
by demographic questienary
2
Description
post natal age
Timepoint
at the time of intervention
Method of measurement
by demographic questienary
3
Description
sex
Timepoint
at birth time
Method of measurement
by physical exam
4
Description
birth weight
Timepoint
at birth time
Method of measurement
by digital scale
Intervention groups
1
Description
recording maternal sound in 5 min for every intervention (3 intervention per day).Every neonate expose to maternal sound 9 times during intervention
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Negar Sajjadian
Street address
North Kargar, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Sponsor of tehran medical university
Street address
keshavarz Blv, 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
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
Full name of responsible person
Negar Najjadian
Position
Assistant prof
Other areas of specialty/work
Street address
keshavarz Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 8163 3568
Fax
+98 81634146
Email
crdc@tums.ac.ir
Web page address
Http://rdc.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Negar Sajjadian
Position
Assistant prof
Other areas of specialty/work
Street address
keshavarz Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 8163 3568
Fax
Email
crdc@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Negar Sajjadian
Position
Assistant prof
Other areas of specialty/work
Street address
Keshavarz Blv, Tehran
City
Tehran
Postal code
Phone
+98 21 8163 3563
Fax
+98 81634146
Email
crdc@tums.ac.ir
Web page address
www.rcd.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)