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IRCT201203086918N5 IRCT 2012-08-04 Deputy of Tabriz University of Medical Sciences olphactory stimulations and pain control in newborn Comparison of Breast Milk and Vanilla Odor Venipuncture Response to Pain in Preterm Infants 28-34 Weeks: Control Randomised Clinical Trial 2012-06-21 anticipated 150 Complete https://irct.ir/trial/7351 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A pain. Intervention 1: Newborns of the mother milk group 9-16 hours before the study will be familiarized with their mother’s milk odor by an sterile swap perfumed with mother᾿s milk which its distance from the infant’s nose is 10 cm. Day of the study this group of infants during the 5 minutes before blood sampling, during sampling and 5 minutes after blood sampling by an sterile swap perfumed with mother᾿s milk will be exposed to the Intended smell from 1 cm distance without contact with the infant’s nose and will be evaluated Neonatal pain response using PIPP tool based on the recorded movies. . Intervention 2: Newborns of the vanilla group 9-16 hours before the study will be familiarized with vanilla Dissolved in glycerol odor by an sterile swap perfumed with vanilla Dissolved in glycerol which its distance from the infant’s nose is 10 cm. Day of the study this group of infants during the 5 minutes before blood sampling, during sampling and 5 minutes after blood sampling by an sterile swap perfumed with vanilla Dissolved in glycerol will be exposed to the Intended smell from 1 cm distance without contact with the infant’s nose and will be evaluated Neonatal pain response using PIPP tool based on the recorded movies. . Intervention 3: Newborns of the control group will not be familiarized with any odor before the study . Day of the study this group of infants during the 5 minutes before blood sampling, during sampling and 5 minutes after blood sampling filmed Whereas will be an sterile swap perfumed with sterilel water on 1 cm distance without contact with the infant’s nose and will be evaluated Neonatal pain response using PIPP tool based on the recorded movies. .
public
scientific Seyedrasooli Alehe
South Shariety St ; Faculty of Nursing & Midwifery ; Tabriz ; Iran
tabriz Iran (Islamic Republic of) +98 41 1479 0365 seyyedrasooly@tbzmed.ac.ir Faculty of Nursing & Midwifery of Tabriz Iran (Islamic Republic of) Inclusion criteria:Having 28 to 34 weeks gestational age; Minimum age is 3 days, mother᾿s milk fed; having experienced the pain of previous sampling; drink milk or sweet liquids 30 minutes before the intervention; have not asphyxia, they have stability With specialist neonatal physiologic view; haven’t any congenital malformation Especially in the nose area; haven’t IVH or PVL; haven’t need to surgery; without mecanical ventilation or CPAP; Baby’s have willingness to participate in the study و Exclusion criteria:Baby will be deleted from the study if the diagnosis neuromuscular complications and congenital abnormalities or create any item that would violate the entry criteria; Baby will be deleted from the study if it is not successful obtaining a blood sample with a disposable needle into the skin and need to again try from sampling; Baby will be deleted from the study if recorded films during the intervention are obscure. no limit 1 year Both P07.3 Other preterm infants. 28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation. Prematurity NOS Prevention Prevention N/A Newborns of the mother milk group 9-16 hours before the study will be familiarized with their mother’s milk odor by an sterile swap perfumed with mother᾿s milk which its distance from the infant’s nose is 10 cm. Day of the study this group of infants during the 5 minutes before blood sampling, during sampling and 5 minutes after blood sampling by an sterile swap perfumed with mother᾿s milk will be exposed to the Intended smell from 1 cm distance without contact with the infant’s nose and will be evaluated Neonatal pain response using PIPP tool based on the recorded movies. . Newborns of the vanilla group 9-16 hours before the study will be familiarized with vanilla Dissolved in glycerol odor by an sterile swap perfumed with vanilla Dissolved in glycerol which its distance from the infant’s nose is 10 cm. Day of the study this group of infants during the 5 minutes before blood sampling, during sampling and 5 minutes after blood sampling by an sterile swap perfumed with vanilla Dissolved in glycerol will be exposed to the Intended smell from 1 cm distance without contact with the infant’s nose and will be evaluated Neonatal pain response using PIPP tool based on the recorded movies. . Newborns of the control group will not be familiarized with any odor before the study . Day of the study this group of infants during the 5 minutes before blood sampling, during sampling and 5 minutes after blood sampling filmed Whereas will be an sterile swap perfumed with sterilel water on 1 cm distance without contact with the infant’s nose and will be evaluated Neonatal pain response using PIPP tool based on the recorded movies. . Pain. Timepoint: 5 minute before blood sampling and during blood sampling and 5 minute after sampling. Method of measurement: with PIPP standard tool. Deputy of Tabriz University of Medical Sciences Approved 2012-06-30 Tabriz University of Medical Sciences tabriz-the end of golgasht street tabriz Iran (Islamic Republic of)