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IRCT20211117053083N1 IRCT 2022-05-07 Rafsanjan University of Medical Sciences "Investigation of the combined effect of maternal touch and voice on neonatal pain"; "Evaluation of the effect of 50% glucose on infant pain relief" Comparison of the effect of combination of touch and mother's voice with glucose 50% on pain reduction of Blood sampling in preterm infants 2020-11-16 anticipated 90 Complete https://irct.ir/trial/60031 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Infants with inclusion criteria were randomly divided into three groups (A, B and C) with six alternate blocks. Six blocks (ABC, ACB, BAC, BCA, CAB and CBA) and a number between 1 and 6 were assigned to each block. The sequence of blocks was determined by rolling the dice, Blinding description: In this study, the researcher was in charge of the intervention and one person entered the study as an outcome assessor who was not aware of the type of intervention in each group and a blind study was performed. N/A pain. Intervention 1: Intervention group 1: The infants in the combined group received sound and Yakson touch from the mother for 5 minutes. The mother touched Yakson while the baby was in bed and while touching the lullaby she had already mentioned, she whispered and blood sampling was performed simultaneously. The Yakson protocol has key aspects of traditional Yakson (warm hands, gentle touch without pressure, and gentle hand movements) that are suitable for premature infants. In Yakson touch, the non-dominant hand is placed on the baby's back and the dominant hand is placed on the baby's chest and abdomen. Intervention 2: Intervention group 2: Infants in the oral glucose group received 2 ml and blood sampling was performed after 2 minutes. Intervention 3: Control group: The infants in the control group received routine care. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Parisa Shahmohammadipour
Nurse Ave., Jomhori Blvd., Rafsanjan
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 heidarzadehazam@yahoo.com Rafsanjan University of Medical Sciences scientific Azam Heidarzadeh
Nurse Ave., Jomhori Blvd., Rafsanjan
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 heidarzadehazam@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) weight less than 2500 g gestational age at birth at least 29 weeks and at most 36 weeks lack of congenital anomalies Failure to receive painkillers or sedatives within the previous 24 hours No need for arterial blood sampling Inequality of blood sampling in two blood samples no intracranial hemorrhage or neurological problems 203 days 273 days Both Need a ventilator Need sedatives Failure to draw blood the first time G89.18 Other acute postprocedural pain Other Other Other Intervention group 1: The infants in the combined group received sound and Yakson touch from the mother for 5 minutes. The mother touched Yakson while the baby was in bed and while touching the lullaby she had already mentioned, she whispered and blood sampling was performed simultaneously. The Yakson protocol has key aspects of traditional Yakson (warm hands, gentle touch without pressure, and gentle hand movements) that are suitable for premature infants. In Yakson touch, the non-dominant hand is placed on the baby's back and the dominant hand is placed on the baby's chest and abdomen Intervention group 2: Infants in the oral glucose group received 2 ml and blood sampling was performed after 2 minutes. Control group: The infants in the control group received routine care. Infant pain. Timepoint: Before and after the intervention. Method of measurement: Neonatal Infant Pain Scale. Rafsanjan University of Medical Sciences Approved 2019-03-12 Ethics Committee of Rafsanjan University of Medical Sciences Jomhori Blvd Rafsanjan Kerman Iran (Islamic Republic of)