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IRCT20180923041101N4 IRCT 2022-04-18 Shiraz University of Medical Sciences Comparison of parental lullabies on pain and neonatal physiological parameters Comparison of the effect of recorded lullaby of father and mother on pain and some physiological indicators in arterial blood sampling of neonates admitted to neonatal intensive care units 2022-05-05 anticipated 51 Complete https://irct.ir/trial/62513 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible infants are randomly assigned to three groups of 17: father lullaby, mother lullaby, and control group, based on the four ABAB-BABA-ABBA-BAAB-AABB-BBAA blocks, Blinding description: The research assistant and the evaluator of the results do not know in which intervention group the infants are. In this way, for the third group (control) to prevent the noise of the environment, headphones will be set without sound playback. N/A Neonates admitted to neonatal intensive care units. Intervention 1: Intervention group1: Father lullaby. First, a lullaby that is sung to the fetus during pregnancy or is about to be sung to the baby will be recorded by the father and will be ready to play for 10 minutes during the blood draw. The recorded lullaby of the father with controlled decibels (35 to 45 decibels) will be played for ten minutes during arterial blood sampling through a headphone that is connected to a sound player and placed on the baby's ear. Intervention 2: Intervention group2: Mother lullaby. First, a lullaby that is sung to the fetus during pregnancy or is about to be sung to her baby will be recorded by the mother and will be ready to play for 10 minutes during the blood draw. The recorded lullaby recorded by the mother in controlled decibels (35 to 45 decibels) will be played for ten minutes during arterial blood sampling through a headphone attached to an audio player and placed on the baby's ear. Intervention 3: Control group: Control. For the control group, headphones will be set without sound to prevent ambient noise. Yes - There is a plan to make this available What will be shared: Analyzed data can be shared after completion of the study as an article When: The access period will start 6 months after the results are published. To whom: All of the researchers in Medical Sciences Universities Conditions: Analysis of data based on statistical software Where to obtain: Dr. Majid Najafi Kalyani How to obtain: Sending request, permission from Ethic Committee, sending data Comments:
public Fatemeh Roozegar
Zand
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4255 fruzegar@gmail.com Shiraz University of Medical Sciences scientific Majid Najafi Kalyani
Namazee St
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4251 Najafikalyani@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Gestational age between 38 and 42 weeks Confirmation of the baby's hearing ability by the doctor Apgar in the normal range No sedative use by the baby during the previous 24 hours No substance abuse and sedative use by the mother No congenital anomalies No intracranial hemorrhage The baby should not be under mechanical ventilation and CPAP 1 day 28 days Both Reluctance of parents to cooperation Instability of physiological status in the infant Behavior Behavior Behavior Intervention group1: Father lullaby. First, a lullaby that is sung to the fetus during pregnancy or is about to be sung to the baby will be recorded by the father and will be ready to play for 10 minutes during the blood draw. The recorded lullaby of the father with controlled decibels (35 to 45 decibels) will be played for ten minutes during arterial blood sampling through a headphone that is connected to a sound player and placed on the baby's ear. Intervention group2: Mother lullaby. First, a lullaby that is sung to the fetus during pregnancy or is about to be sung to her baby will be recorded by the mother and will be ready to play for 10 minutes during the blood draw. The recorded lullaby recorded by the mother in controlled decibels (35 to 45 decibels) will be played for ten minutes during arterial blood sampling through a headphone attached to an audio player and placed on the baby's ear. Control group: Control. For the control group, headphones will be set without sound to prevent ambient noise. Pain score. Timepoint: From ten minutes before to ten minutes after neonatal arterial blood sampling. Method of measurement: NIPS scale. Heart rate. Timepoint: From ten minutes before to ten minutes after neonatal arterial blood sampling. Method of measurement: Baby heart rate monitoring. Blood oxygen saturation. Timepoint: From ten minutes before to ten minutes after neonatal arterial blood sampling. Method of measurement: Pulseoximetry. Shiraz University of Medical Sciences Approved 2021-12-18 Schools of Nursing and Midwifery, Management and Medical Information science- - Shiraz University of Zand Shiraz Fars Iran (Islamic Republic of)