The effect of lullabies on some physiologic and behavioral responses during endotracheal suctioning in premature neonates in neonatal intensive care unit in a Shiraz Medical Sciences University hospital.
1)Objectives: Determining the effect of lullabies on some physiologic and behavioral responses during endotracheal suctioning in premature infants in neonatal intensive care unit. 2) Design: Single-blind randomized clinical trial 3) Setting and conduct: 25 infants qualified for the study are randomly assigned to A and B groups by using the sealed envelope method. The lullaby is played for the babies in group A before and after the suctioning and then it will not be played for the next 24 hours. The order is reversed for the babies in group B. In both groups,the babies are filmed for 20 minutes and heart rate, blood oxygen saturation and behavioral states are recorded by APIB scale. Finally, the changes in the physiological and behavioral parameters of the two groups are compared. 4) Participants including major eligibility criteria: Postnatal age 1 to 28 days after birth; gestational age 28 to 36 weeks; neonate's need to endotracheal suctioning; no sedative medicine use during the past 24 hours; no maternal drug or sedative abuse; neonatal hearing ability (having startle reflex); no congenital malformation; no evidence of grade II or higher intraventricular hemorrhage or neurological disorders; not having used invasive procedures for the baby for at least 3 hours; endotracheal tube insertion at least 24 hours earlier. Major exclusion criteria: Parents' unwillingness to continue cooperating in research; symptoms of physiological instability in the infant. 5) Interventions: Playing lullaby before and after the suctioning 6) Main outcome measures (variables): Heart rate, blood oxygen saturation, and behavioral responses.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121124037N2
Registration date:2017-05-18, 1396/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-18, 1396/02/28
Registrant information
Name
Zahra Zahadatpour
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3720 2096
Email address
zahadatpour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lullabies on some physiologic and behavioral responses during endotracheal suctioning in premature neonates in neonatal intensive care unit in a Shiraz Medical Sciences University hospital.
Public title
The effect of lullabies on physiological and behavioral parameters among the preterm neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Postnatal age 1 to 28 days after birth; gestational age 28 to 36 weeks; neonate's need to endotracheal suctioning; no sedative medicine use during the past 24 hours; no maternal drug or sedative abuse; neonatal hearing ability (having startle reflex); no congenital malformation; no evidence of grade II or higher intraventricular hemorrhage or neurological disorders; not having used invasive procedures for the baby for at least 3 hours; endotracheal tube insertion at least 24 hours earlier. Exclusion criteria: Parents' unwillingness to continue cooperating in research; symptoms of physiological instability in the infant;having Heart disease; Pneumothorax
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Sealed envelope method randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2015-08-24, 1394/06/02
Ethics committee reference number
IR.SUMS.REC.1394.92
Health conditions studied
1
Description of health condition studied
preterm infant
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Heart rate
Timepoint
from 10 minutes before suctioning until 10 minutes after suctioning
Method of measurement
Pulse oxymeter
2
Description
Blood oxygen saturation
Timepoint
from 10 minutes before suctioning until 10 minutes after suctioning
Method of measurement
Pulse oxymeter
3
Description
Behavioral responses.
Timepoint
from 10 minutes before suctioning until 10 minutes after suctioning
Method of measurement
APIB scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: at first receiving lullabies and after 24 hours receiving headphones without playing lullabies
Category
Prevention
2
Description
Control group:at first receiving headphones without playing lullabies and after 24 hours receiving lullabies
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zeinab Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, shiraz 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
Shiraz University of Medical Sciences, Hazrat-e-Fatemeh Nursing and Midwifery Faculty
Full name of responsible person
Zahra Zahadatpour
Position
Neonatal Intensive Care Nursing Master of Science Student
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3720 2096
Fax
Email
zahadatpour@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Hazrat-e-Fatemeh Nursing and Midwifery Faculty
Full name of responsible person
Mitra Edraki
Position
Pediatric Nursing MS, Faculty member
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4257
Fax
Email
Mitraedraki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Hazrat-e-Fatemeh Nursing and Midwifery Faculty
Full name of responsible person
Zahra Zahadatpour
Position
Neonatal Intensive Care Nursing Master of Science Student
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4257
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)