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IRCT20131228015965N20 IRCT 2020-09-01 Rafsanjan University of Medical Sciences Investigation and Comparing the effects of foot reflexology and sucrose 24% with pacifier on severity of neonatal Abstinence syndrome among the neonates with addicted mother Investigation and Comparing the effects of foot reflexology and sucrose 24% with pacifier on severity of neonatal Abstinence syndrome, Hearth rate and Respiratory rate among the neonates with addicted mother 2019-10-22 anticipated 90 Complete https://irct.ir/trial/50416 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be done by block randomization method and based on that, the participants will be placed in one of the intervention and control groups and in a randomized block in terms of material consumed by the mother and Fingan score and type of feeding. Randomization will be performed by a blind staff to study, Blinding description: Participants are blind (blindness is based on the fact that they are infants) and will be intervened in a separate room. It will also be blind. N/A neonatal Abstinence syndrome. Intervention 1: Intervention group 1: In the sucrose group with pacifier, 2 cc of sucrose solution for infants over 2 kg and 1.5 cc for infants 1.5 to 2 kg and 0.5 cc for infants under 1.5 kg of sucrose 24%(Made by Shahid Ghazi Pharmaceutical Company) Pour a sterile syringe on the front of the baby's tongue, the dose of sucrose was selected based on studies in this field (50) and then put the pacifier in the baby's mouth for 15 minutes. Interventions will be performed twice a day, 12 hours apart. Heart rate was measured using a pulse oximetry device (calibrated and identical), respiration rate was counted, and deprivation syndrome score was measured using the Finigan checklist before the intervention and then 15 minutes and 2 hours after the intervention. Intervention 2: Second intervention group:. In the reflexology group, infants will receive a foot massage (reflexology belief is based on the fact that the foot is a reflection of different organs of the body and foot massage affects different systems). In this intervention, we use zone number one, which is the thumb and toes. We chose that it is directly related to the head and neck and the secretion of endorphins. Reflexology intervention will be performed for 15 minutes. The pressure of the massage is such that the blood supply to the target organ is not disturbed. The basis of Finger Walking is that we first massage the sole of the baby's foot completely, from the heel vertically and walking, with the index finger, and then the desired area will be massaged more. Interventions will be performed twice a day, 12 hours apart. Heart rate using pulse oximetry device (calibrated and identical), number. Intervention 3: Control group: The control group will have only the presence of the intervener and the heart rate using the pulse oximetry device (calibrated and identical), the number of breaths counted and the deprivation syndrome score using the Finigan checklist before the intervention and then 15 minutes. And is measured 2 hours after the intervention. Interventions will be performed twice a day, 12 hours apart. 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 Sedighe Gholami Shiri
Tavanir Street
Kerman Iran (Islamic Republic of) 7618469184 +98 930 822 5514 gholamidesigh@gmail.com Rafsanjan University of Medical Sciences scientific Dr.Majid Kazemi
Ali ibn Abi Taleb Squre, Imam Ali Street
Rafsanjan Iran (Islamic Republic of) 7717933777 000034283498+ Maj_Kaz@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Newborns born with term maternal addiction during pregnancy Get a score of 8 or higher on the Finigan checklist Being hospitalized in educational and medical centers of the place of study Having parental consent 1 day 28 days Both Having congenital problems, congenital anomalies and injuries during childbirth Having respiratory problems and other problems affecting the symptoms of deprivation P96.1 Neonatal withdrawal symptoms from maternal use of drugs of addiction N/A N/A N/A Intervention group 1: In the sucrose group with pacifier, 2 cc of sucrose solution for infants over 2 kg and 1.5 cc for infants 1.5 to 2 kg and 0.5 cc for infants under 1.5 kg of sucrose 24%(Made by Shahid Ghazi Pharmaceutical Company) Pour a sterile syringe on the front of the baby's tongue, the dose of sucrose was selected based on studies in this field (50) and then put the pacifier in the baby's mouth for 15 minutes. Interventions will be performed twice a day, 12 hours apart. Heart rate was measured using a pulse oximetry device (calibrated and identical), respiration rate was counted, and deprivation syndrome score was measured using the Finigan checklist before the intervention and then 15 minutes and 2 hours after the intervention. Second intervention group:. In the reflexology group, infants will receive a foot massage (reflexology belief is based on the fact that the foot is a reflection of different organs of the body and foot massage affects different systems). In this intervention, we use zone number one, which is the thumb and toes. We chose that it is directly related to the head and neck and the secretion of endorphins. Reflexology intervention will be performed for 15 minutes. The pressure of the massage is such that the blood supply to the target organ is not disturbed. The basis of Finger Walking is that we first massage the sole of the baby's foot completely, from the heel vertically and walking, with the index finger, and then the desired area will be massaged more. Interventions will be performed twice a day, 12 hours apart. Heart rate using pulse oximetry device (calibrated and identical), number Control group: The control group will have only the presence of the intervener and the heart rate using the pulse oximetry device (calibrated and identical), the number of breaths counted and the deprivation syndrome score using the Finigan checklist before the intervention and then 15 minutes. And is measured 2 hours after the intervention. Interventions will be performed twice a day, 12 hours apart. On severity of neonatal Abstinence syndrome. Timepoint: Twice a day for 12 hours, before and then 15 minutes and 2 hours after the intervention. Method of measurement: Fingan Tools. Number of breaths. Timepoint: Twice a day 12 hours before the intervention, 15 minutes and 2 hours after the intervention. Method of measurement: Counting. Heart rate. Timepoint: Twice a day 12 hours before the intervention, 15 minutes and 2 hours after the intervention. Method of measurement: Pulse oximetry device. Rafsanjan University of Medical Sciences Approved 2019-07-16 Rafsanjan University Of Medical Sciences Imam Ali Street Rafsanjan Kerman Iran (Islamic Republic of)