Protocol summary

Summary
The aim of this study was to determine the analgesic and physiologic effects of warmth in neonates undergoing intramuscular injection of vitamin K. Appropriate for gestational age infants of 37/1- 42 weeks of gestational age were included. Infants of mothers with substance abuse, infants of diabetic mothers, neonates with asphyxia, first and fifth minute Apgar score less than 7 were excluded. We observed the behavioral state only after the infant had spontaneously reached 1 of 3 quiet behavioral states (State 1: eyes closed, regular respiration, no movements; state 2: eyes closed, irregular respiration, small movements; or state 3: eyes open, no movements). Forty infants were divided in control and intervention groups in the first hour after birth. The protocol consisted of baseline (2 min), intervention (2 min), injection (20 s ), and recovery (2 min) periods. Infants in the intervention group were warmed by radiant warmer, first in manual mode with 100% power for 2 minutes followed by servo controlled mode with 35 degrees. Infants in the control group were also warmed by radiant warmer but only at 35 degrees in servo controlled mode during the study. Maximum heart rate and oxygen saturation were recorded two minutes before, during and two minutes after the injection in thirty-second intervals . Pain measurement were recorded independently (with NIPS scale) through video recording.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051117645N1
Registration date: 2014-06-07, 1393/03/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-07, 1393/03/17
Registrant information
Name
Behnaz Mirzaee
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5558 0187
Email address
behnazmirzaee61@yahoo.com
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2013-11-16, 1392/08/25
Expected recruitment end date
2013-12-16, 1392/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of warmth during intramuscular injection of vitamin K on physiological indicators and pain in term newborns
Public title
The effect of neonatal warming up on pain management and physiological indicators in term newborns
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: infants with gestational age 37/1- 42 week with appropriate weight for gestational age; lack of palliative sedation or anti convulsion drugs during pregnancy maternal. Exclusion criteria: infants of mothers with substance abuse; infants of mothers with diabetes; neonates with asphyxia; anomalies of the face and extremities; first and fifth minute Apgar score less than 7.
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not 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
Babol University of Medical Sciences, Ganj Afroz Ave, Babol, Mazandaran
City
Babol
Postal code
4717641367
Approval date
2013-11-05, 1392/08/14
Ethics committee reference number
3326

Health conditions studied

1

Description of health condition studied
The correlation of neonatal warming up infant during intramuscular injection of vitamin K with pain and physiological indicators in term infants
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Oxygen saturation
Timepoint
Two minutes before injection, during the injection, two minutes after injection
Method of measurement
Pulse Oximeter

2

Description
Pain
Timepoint
Two minutes before injection, during injection, two minutes after injection
Method of measurement
Neonatal Infant Pain Scale (NIPS)

3

Description
Heart rate
Timepoint
Two minutes before injection, during injection, two minutes after injection
Method of measurement
Pulse Oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Infants in the intervention group were exposed warmth in manual mode and 100% power of warmer (HKN- 93B Model) for 2 minutes during intervention phase .
Category
Prevention

2

Description
Infants in the control group has not taken intervention and just were exposed in servo controlled mode with 35 degrees (35 degrees) during the study.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Mirzaee Behnaz, NeonataI Intensive Care Nursing Student
Street address
Nursery Ward, Ayatollah Rouhani Hospital, Ganj Afrooz Ave, Babol, Mazandaran, Iran
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahid Pasha Ydllh
Street address
Research and Technology Department, Babol University of Medical Sciences, Babol, Mazandaran
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
Mirzaee Behnaz
Position
NeonataI Intensive Care Nursing Student
Other areas of specialty/work
Street address
Zanan Hospital, Karim Khan Zand Ave, Tehran, Iran
City
Tehran
Postal code
1199734113
Phone
+98 21 5558 0187
Fax
Email
behnazmirzaee61@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Education, Babol University of Medical Sciences
Full name of responsible person
Zahid Pasha Ydllh
Position
Neonatologist, Professor
Other areas of specialty/work
Street address
Department of Education, Babol University of Medical Sciences, Ganj Afrooz Ave, Babol, Mazandaran, Iran
City
Babol
Postal code
47745-47176
Phone
+98 11 1219 9592
Fax
+98 11 1219 0181
Email
yzpasha@yahoo.com M_Amoozesh@mubabol.ac.ir
Web page address
http://education.mubabol.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mirzaee Behnaz
Position
Neonatal Intensive Care Nursing Student
Other areas of specialty/work
Street address
Zanan Hospital, Karim Khan Zand Ave, Tehran
City
Tehran
Postal code
1199734113
Phone
+98 21 5558 0187
Fax
Email
behnazmirzaee61@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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