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IRCT20180526039844N1 IRCT 2018-07-03 Esfahan University of Medical Sciences Effect of Voice and Tune in pain of neonates Comparison of the effectiveness of relaxing Voice and Tune voices using voice pillow on pain intensity of heel stick in hospitalized neonates 2018-03-13 anticipated 84 Complete https://irct.ir/trial/31481 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, audio pillows are used to play music, which is an innovation aspect and the pillow is designed to not damage the baby's ear, and with a sound level for babies of 35-40 dB that accurately measures this volume, Randomization description: Small cards are made up of the total volume of the sample, and they are written in the Voice group, the Tune intervention and the control group, each with the same number and the size of the sample size in each group. Then the cards are placed inside the box and, during the sampling, according to The card accident crashes out of the box and the newborn is placed in the same group and the cards are picked out of the box. This will continue until the entire card is removed from the box, Blinding description: Simultaneously, by sampling the changes in the face and limb of the infant, a researcher colleague randomly assigned to the groups is filmed, and the films will be encoded by the first fellow of the researcher without specifying the intervention group or the control group. And the code is behind the card The second collaborator who does not group videos of newborns reviews the videos and evaluates them according to the Nips criteria. Then, the researcher will match the code with the code behind the cards, which determines which score is for which intervention group, and analyzes the data he is doing it. N/A Pain caused by neonatal blood sampling. Intervention 1: In the first intervention (voice group), the baby is sleeping on an acoustic pillow and a sedative vocal with specific sound intensity (35-40 dB) is distributed to the baby. Then, after 3 minutes, he takes blood from the baby and is filmed by a researcher fellow. The second co-worker examines films for the baby. Intervention 2: Intervention group:(tune group): In the second intervention (the tune group), the baby is sleeping on an audio pillow and the sedative with a specific voice intensity (40-35 dB) is distributed to the baby. Then, 3 minutes later, he takes blood from the newborn and infants by the partner The researcher filmed and the second colleague of the researcher scores videos for the baby. Intervention 3: . Intervention 4: Control group:The baby is sleeping on the audio pillow and without any intervention, after 3 minutes, the baby is taken from the infant and the baby is filmed by a researcher's colleague and the second co-worker is evaluating the films for the baby. Yes - There is a plan to make this available What will be shared: In this study, the score for neonatal pain is given on a neon film. Neonatal films are not shared, but the pain score will be shared in the intervention and control groups When: Get started 6 months after printing results To whom: For researchers working in academic and scientific institutions Conditions: In order to cite the results of data in research studies Where to obtain: mrabiey1356@gmail.com How to obtain: The requestor can receive files within two weeks from sending emails through the introduction of his specifications by email and for which purpose he wants to Comments:
public Manijeh Rabiei
Esfahan University of Medical Sciences, Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1668 7153 mrabiey1356@gmail.com Esfahan University of Medical Sciences scientific Manijeh Rabiei Faradonbeh
Esfahan University of Medical Sciences, Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1668 7153 mrabiey1356@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Baby has a fetal age of 34 weeks and older The need for blood sampling from the heel There is no congenital anomaly in the form of cleft lip and palate The baby is not sleeping and is not crying Do not use a sedative or medication within 24 hours The baby has no hearing problem Failure to receive other painful procedure before intervention 238 days 273 days Both Babies under 34 weeks No need to bleed from the heel There is a hearing problem Congenital malformation of the cleft lip and palate The baby is sleeping or crying Has received a home medicine within the last 24 hours Y84.7 Blood-sampling as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Devices Treatment - Devices Treatment - Devices In the first intervention (voice group), the baby is sleeping on an acoustic pillow and a sedative vocal with specific sound intensity (35-40 dB) is distributed to the baby. Then, after 3 minutes, he takes blood from the baby and is filmed by a researcher fellow. The second co-worker examines films for the baby. Intervention group:(tune group): In the second intervention (the tune group), the baby is sleeping on an audio pillow and the sedative with a specific voice intensity (40-35 dB) is distributed to the baby. Then, 3 minutes later, he takes blood from the newborn and infants by the partner The researcher filmed and the second colleague of the researcher scores videos for the baby Control group:The baby is sleeping on the audio pillow and without any intervention, after 3 minutes, the baby is taken from the infant and the baby is filmed by a researcher's colleague and the second co-worker is evaluating the films for the baby Intensity of pain. Timepoint: 3 minutes after playing voice or tune, through the pillow and in the control group 3 minutes after pillow sleep. Method of measurement: Neonatal Infants Pain Scale. Score pain severity. Timepoint: 3 minutes after the intervention. Method of measurement: Neonatal Infant Pain Scale. Esfahan University of Medical Sciences Approved 2018-02-26 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib street,isfahan Isfahan Isfehan Iran (Islamic Republic of)