are categorized into 3 groups.
First group: The infants of this group listen to their mothers’ live voice for 10 minutes.
Second group: In this group, the mother stands beside the incubator for 10 minutes but does not speak to the infant.
Third Group: The infants of this group listen to the nurse’s (researcher) live voice for 10 minutes.
The study is in this way: The infants understudy are placed inside the incubator. For all of the three groups, 10 minutes before the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes using a pulse oximeter made in USA (Masimo) which is on one side positioned on the infant’s foot and on the other side attached to a monitoring system (Saadat) made in Iran through three chest leads and neonatal pressure cuffs in various sizes each of which are connected to the system with separate cables. Similarly, the vital signs are recorded in the second 10 minutes; but this time in three different situations including mother’s presence with her voice, mother’s presence without voice and nurse’s presence with her voice. In the last 10 minutes also the vital signs are recorded without the mother or nurse’s presence. It should be noted that the infantsare not being fed during the intervention and evaluation and they are under study for 3 consecutive days from 3 to 5 PM. The mother and the nurse are not allowed to touch the infant during the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081623636N1
Registration date:2015-09-16, 1394/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-16, 1394/06/25
Registrant information
Name
Mozhgan Ahmadi Vastani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 353 0723
Email address
m.ahmadi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2014-12-21, 1393/09/30
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of live maternal voice on physiologic factors of premature infants hospitalized in NICU
Public title
The effect of live maternal voice on physiologic factors of premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:
Premature infants with gestational age of 28 to less than 37 weeks; Birth weight of more than 1 kilograms and less than 2.5 kilograms; Infants that are at least 3 days old; Infants that are kept in incubator, have physiological stability and no congenital anomalies and their inclusion in the study is confirmed by the shift attending; Infants that are not under the effect of any kind of ventilation such as nasal cannula, positive pressure ventilation through nasal mask or ventilator; Receiving no muscle relaxant drug; Not having surgery; Infants that are merely fed by their mother’s milk.
Exclusion Criteria:
Startle reflex/ (ABR) hearing test indicate hearing impairment; Definitive diagnosis of the following issues during the intervention:Intraventricular hemorrhage with grade 2 and above; Necrotizing enterocolitis; patent ductus arteriosus; sepsis; acute lung disease; anemia (Hb<10gm / dr); occurrence of seizure and mother’s unwillingness to cooperate; Infants that use pacifier or are fed by things other than mother’s milk; Reports that indicate mother’s known addiction to alcohol, addictive drugs (narcotic drugs) and psychotropic substances;The mother receive hypnotic drugs in the intervention day.
Age
From 3 days old to 29 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences,
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.
City
Babol
Postal code
4717647745
Approval date
2015-06-02, 1394/03/12
Ethics committee reference number
MUBABIL.REC.1394.36
Health conditions studied
1
Description of health condition studied
Premature infant
ICD-10 code
P07
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified
Primary outcomes
1
Description
Heart rate
Timepoint
10 minut before-10 minute during-10 minute after intervention
Method of measurement
Monitor
2
Description
Respiratory rate
Timepoint
10 minut before-10 minute during-10 minute after intervention
Method of measurement
Monitor
3
Description
Blood pressure
Timepoint
10 minut before-10 minute during-10 minute after intervention
Method of measurement
Monitor
4
Description
Saturation of pressure of O2
Timepoint
10 minut before-10 minute during-10 minute after intervention
Method of measurement
Monitor
Secondary outcomes
empty
Intervention groups
1
Description
First group: The infants of this group listen to their mothers’ live voice for 10 minutes.This group, 10 minutes before، 10 minutes during، 10 minutes after the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes.
Category
Behavior
2
Description
Second group: In this group, the mother stands beside the incubator for 10 minutes but does not speak to the infant. This group, 10 minutes before، 10 minutes during، 10 minutes after the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes.
Category
Behavior
3
Description
Third Group: The infants of this group listen to the nurse’s (researcher) live voice for 10 minutes.This group, 10 minutes before، 10 minutes during، 10 minutes after the intervention, the nurse records heart rate, blood oxygen saturation, blood pressure and respiratory rate every five minutes.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali Hospital
Full name of responsible person
Mozhgan Ahmadi Vastani
Street address
Boali Hospital، Pasdaran boulevadr، Sari، Mazandaran Province، IR Iran
City
Sari
2
Recruitment center
Name of recruitment center
Emam Hospital
Full name of responsible person
Mozhgan Ahmadi Vastani
Street address
Emam Hospital،Amir mazandarani boulevard، Sari، Mazandaran Province، IR Iran
City
Sari
3
Recruitment center
Name of recruitment center
Amirkola Children’s Hospital
Full name of responsible person
Mozhgan Ahmadi Vastani
Street address
Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province، IR Iran.
City
Amirkola
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Chancellor for Research Technology Affairs
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mozhgan Ahmadi Vastani
Position
Student of Ms In Neonatal Intensive care Unit
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.
City
Babol
Postal code
4717647745
Phone
+98 11 3310 5346
Fax
+98 11 3219 0181
Email
Mozhganahmadivastani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Yadolla Zahed Pasha
Position
Neonatologist، Professor
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.
City
Babol
Postal code
4717647745
Phone
+98 113219959296
Fax
+98 981132190181
Email
Zypasha@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mozhgan Ahmadi Vastani
Position
Student of Ms In Neonatal Intensive care Unit
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.
City
Babol
Postal code
4717647745
Phone
+98 11 3310 5346
Fax
00891132190181
Email
Mozhganahmadivastani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)