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IRCT2015010220529N1 IRCT 2015-02-16 Vice chancellor for research, Mashhad University of Medical Sciences The effect of scent and glucose on pain of neonates Comparison of the effect of familiar olfactory stimulation (lavender scent) and glucose on pain from blood sampling in term neonates 2012-03-19 anticipated 120 Complete https://irct.ir/trial/18195 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Neonates (N = 120) were randomly assigned to three groups: aromatherapy (n = 40), glucose (n=40) and control group (n = 40). Method of sampling infants in this study is convenient sampling. Because it was probable for the other two groups to be exposed to the lavender scent spread from aromatherapy group (diffusion effect), sampling was done only for one group during each week, with groups being randomly selected; in other words, on the first day, the name of each group was written on a separate piece of paper, then was lottery. During each week, eligible cases were recognized and selected by convenience sampling only for one group, and groups were replaced respectively. Blinding was performed in a manner that the person who Implemented the pain scale was unaware of the purposes of research and study groups. N/A pain. Intervention 1: Without receipt specific intervention for pain, blood samples were taken. Intervention 2: Infants at night for 8 hours before blood sampling were exposed to the scent of lavender. And the next day, at the time of blood sampling was used of the scent of lavender. Intervention 3: Infants 2 minutes before the taking blood sample received 2 cc edible glucose 30%.
public Naghmeh Razaghi
Ibn Sina Street, doctora intersection
Mashhad Iran (Islamic Republic of) +98 51 3859 1511 razaghin@mums.ac.ir Mashhad University of Medical Sciences scientific Naghmeh Razaghi
Ibn Sina Street, doctora intersection
Mashhad Iran (Islamic Republic of) +98 51 3859 1511 razaghin@mums.ac.ir Mashhad University of Medical Science Iran (Islamic Republic of) Inclusion criteria: a- Gestational age over 37 weeks, b- Appearance, Pulse, Grimace, Activity, Respiration (APGAR) scores at five minutes greater than seven c- Non-use of tranquilizer or sedative and anticonvulsant drug during the last 24 hours by mother and neonate d- Need for venous blood sampling e- Stability in general and clinical status f- Oral feeding is not prohibited g- The mother has not received any opioid i- Lack of Diabetes in the mother. Exclusion criteria: a- If the baby in the familiar scent group, should be taken blood sampling during the orientation phase. b- If the infants in the familiar scent group, during the familiar within scent up to blood sampling, was discharged or to cause any complications or problems that interfere with the natural trend of neonatal care, orientation phase stop. c- If the infant receive milk or any sugar within thirty minutes prior to the start of the blood sampling. d- If the infant is restless and uneasy before blood sampling. e- If the first attempt for blood sampling was not successful. 3 days 13 days Both R52 pain not referable to any one organ or body region N/A Treatment - Other Treatment - Other Without receipt specific intervention for pain, blood samples were taken. Infants at night for 8 hours before blood sampling were exposed to the scent of lavender. And the next day, at the time of blood sampling was used of the scent of lavender. Infants 2 minutes before the taking blood sample received 2 cc edible glucose 30% Pain. Timepoint: Immediately after the entry of the needle into the vein. Method of measurement: Pain assessment scale scores Douleur Aigue Nouveau-ne (DAN).The scale is used to evaluate 3 items: facial expressions, limb movements and vocal expression. The duration of crying. Timepoint: According to seconds, in 3 minutes at the beginning of the blood sampling was measured. Method of measurement: Stopwatch. Vice chancellor for research, Mashhad University of Medical Sciences Approved 2010-12-11 Ethics committee of Mashhad University of Medical Sciences Daneshgah Ave,Ghorashi building Mashhad Iran (Islamic Republic of)