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IRCT20181028041482N1 IRCT 2018-12-13 Tehran University of Medical Sciences Assessing Fetal position in neonates undergoing open-heart surgery FPT Assessing the effect of fetal position on the severity of pain during chest tube removal in neonates undergoing open-heart surgery 2018-11-22 anticipated 30 Complete https://irct.ir/trial/34874 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: method of randomization: Simple randomization unit of randomization: Individual tools used in randomization: flip the coin random sequence: single Allocation concealment: single-blind, Blinding description: The parents of neonates were in the course of receiving their newborns' treatment, but they were not informed with either interventional or control groups, and thus single-blind study. In addition, neonatal nurses were not aware of the presence of newborns in the control or intervention group. The doctor in charge of removing the chest tube did not know the type of infant group. 2 Assessing the effect of fetal position on severity of pain during chest tube removal in neonates undergoing open heart surgery. Intervention 1: Intervention group: Neonates in the intervention group, in addition to the administration of 0.05 mg of morphine 20 minutes prior to the removal of the chest tube, the neonate is placed by the nurse trained in the fetal position and the chest tube is given by the physician who is for all Neonates of the two fixed groups are removed and the physiological signs of pain (heart rate-respiration and blood oxygen saturation) and neonatal pain infant scale (NIPS) before and immediately after removal of The chest tube is examined and recorded 5 minutes after removing the chest tube. Intervention 2: Control group:Neonates in the intervention group, in addition to the administration of 0.05 mg of morphine 20 minutes prior to the removal of the chest tube,and the chest tube is given by the physician who is for all Neonates of the two fixed groups are removed and the physiological signs of pain (heart rate-respiration and blood oxygen saturation) and neonatal pain infant scale (NIPS) before and immediately after removal of The chest tube is examined and recorded 5 minutes after removing the chest tube. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "There is no more information".
public Somayeh ashtari
No. 14, Riahi Alley, Barzegar Alley, Amirieh ave, Valie asr Ave
Tehran Iran (Islamic Republic of) 1194815814 +98 21 5537 7749 S_ashtari24@yahoo.com Tehran University of Medical Sciences scientific Somayeh Ashtari
No. 14 , Riahi Alley, Barzegar Alley, Amirieh Ave, Valie asr Ave
Tehran Iran (Islamic Republic of) 1194815814 +98 21 5537 7749 s_ashtari24@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Neonates with 1 to 28 days old neonates with 2500 to 4000 grams weight neonates extubed of ventilator neonates with chest-tube completion of consent form by parents 1 day 28 days Both Neonates who have a prohibition of positioning (such as neonates with chest infection) Neonates with drug deprivation syndrome Treatment - Drugs Treatment - Drugs Intervention group: Neonates in the intervention group, in addition to the administration of 0.05 mg of morphine 20 minutes prior to the removal of the chest tube, the neonate is placed by the nurse trained in the fetal position and the chest tube is given by the physician who is for all Neonates of the two fixed groups are removed and the physiological signs of pain (heart rate-respiration and blood oxygen saturation) and neonatal pain infant scale (NIPS) before and immediately after removal of The chest tube is examined and recorded 5 minutes after removing the chest tube. Control group:Neonates in the intervention group, in addition to the administration of 0.05 mg of morphine 20 minutes prior to the removal of the chest tube,and the chest tube is given by the physician who is for all Neonates of the two fixed groups are removed and the physiological signs of pain (heart rate-respiration and blood oxygen saturation) and neonatal pain infant scale (NIPS) before and immediately after removal of The chest tube is examined and recorded 5 minutes after removing the chest tube. Severity of pain. Timepoint: Before intervention، During the intervention ، 5 minutes after intervention. Method of measurement: NIPS(Neonatal infant pain scale). Severity of pain score. Timepoint: Before intervention, During the intervention ,5 minutes after intervention. Method of measurement: Neonatal infant pain Scale. Fetal of position. Timepoint: Before intervention - during intervention - 5 minutes after intervention. Method of measurement: NIPS(Neonatal infant pain scale). Tehran University of Medical Sciences Approved 2018-10-27 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qodse Ave, keshavarze Blvd Tehran Tehran Iran (Islamic Republic of)