This study aimed to compare the efficacy of oral dextrose and the use of fetal pain caused by arterial blood sampling in preterm infants done.Inclusion criteria require arterial blood sampling, gestational age between 32 and 37 weeks, the absence of Syfksy (PH 7.2 and Apgar score 5 minutes after birth, the umbilical cord following hypoxic-ischemic encephalopathy 7 and associated symptoms), no use of drugs, benzodiazepines and phenobarbital 24 hours before, and exclusion criteria addicted mothers, infants with necrotizing enterocolitis (NEC) step 3.2, the ban on eating through the mouth and if not considered at the discretion of the physician.The sample of infants admitted to the neonatal intensive care unit were selected. 120 infants with a dice after random assignment to one of three groups: oral dextrose, placement will be in the fetal position without interference. collect information in three primary (baby belay), case (arterial blood) and recovery (3 minutes after blood sampling) is done.Infant oral dextrose in 1 cc of dextrose 50% of its volume is 1 cc to 2 cc of sterile distilled water solution was to get two minutes before the procedure.The second group, the nurse placed his left hand on the head with his right hand tucked inside the lower extremities to the belly of the baby kept.Use the tool to assess pain in preterm infants in neonatal pain in different groups before and after the procedure will be determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408029568N9
Registration date:2014-09-08, 1393/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2014-09-08, 1393/06/17
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Maternal and Fetal Research Center
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral dextrose and facilitated tucking in reducing pain associated with arterial blood sampling in preterm infants
Public title
Effect of blood sampling pain in newborns
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:Gestational age from 32 to 37 weeks of pregnancy, lack Syfksy conditions (PH umbilical sub 7/2 and 5 minute Apgar score below 7 after birth and symptoms of hypoxia ischemic encephalopathy), not using drugs, benzodiazepines and phenobarbital in 24 Hours intervention.
Exclusion criteria for newborns of addicted mothers, infants with necrotizing enterocolitis (NEC) stage was 3.2 and in the absence of the physician's discretion.
Age
From 32 years old to 37 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences/Research Center for Maternal and newborn baby
Street address
Research Center for Maternal and newborn baby-Second Floor-Asr Hospital-Gharib Street- Keshavarz Street
City
Tehran
Postal code
Approval date
2014-05-19, 1393/02/29
Ethics committee reference number
25966
Health conditions studied
1
Description of health condition studied
Acute Pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Pain
Timepoint
before of intervention, after of intervention
Method of measurement
Premature Infant Pain Profile
Secondary outcomes
empty
Intervention groups
1
Description
Dextrose 50% group, dextrose solution, the volume of 1 cc to 2 cc of sterile distilled water before sampling using a syringe Dvdqyqh has been fed to infants
Category
Prevention
2
Description
The facilitaed tucking group, infants before and during blood collection kept by a nurse in the fetal position
Category
Prevention
3
Description
Whithout intervention group,the usual hospital routine infant did not receive the intervention to relieve pain prior to blood sampling
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Master ofMedical Sience/Asr Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences/ Maternal Fetal Neonatal Research Center
Full name of responsible person
Mamak Shariat
Street address
Second Floor, Asr Hospital, Imam Khomeini Complexex, Gharib Street, Keshavarz Blv
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/ Maternal Fetal Neonatal Research Center
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/Asr hospital
Full name of responsible person
Athareh Ranjbar
Position
Master of Nursing/ Health Education Supervisor
Other areas of specialty/work
Street address
Second Floor, Asr Hospital, Imam Khomeini Hospital Complexex, Gharib Street, Keshavarz Blv
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 0020
Fax
Email
athare_ranjbar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences/Maternal Fetal Neonatal Research Center
Full name of responsible person
Nikoo Niknafs
Position
Professor/Neonatologist
Other areas of specialty/work
Street address
Second Floor, Asr Hospital, Imam Khomeini Complexex, Gharib Street, Keshavarz Blv
City
Tehran
Postal code
1419733141
Phone
+98 21 6691 2357
Fax
Email
nikoo.niknafs@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences/Maternal Fetal Neonatal Research Center
Full name of responsible person
Athareh Ranjbar
Position
Master of nursing/ Health Education Supervisor
Other areas of specialty/work
Street address
Second Floor, Asr Hospital, Imam Khomeini Complexex, Gharib Street, Keshavarz Blv
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 0020
Fax
Email
athare_ranjbar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)