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IRCT20250820066925N1 IRCT 2025-09-20 Shiraz University of Medical Sciences Comparison of the effect of binaural music and mothers lullaby on some physiological indicators and pain caused by endotracheal suction in term newborns hospitalized in neonatal intensive care units of hospitals affiliated to Shiraz University of Medical Sciences Comparison of the effect of binaural music and mothers lullaby on some physiological indicators and pain caused by endotracheal suction in term newborns hospitalized in neonatal intensive care units of hospitals affiliated to Shiraz University of Medical Sciences 2025-09-23 anticipated 51 Complete https://irct.ir/trial/85675 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: All three groups will receive routine neonatal pain management. Intervention group A will additionally receive binaural beat music with controlled decibel levels from 10 minutes before suction until 10 minutes after. Intervention group B will receive a recorded maternal lullaby under the same conditions. The control group will wear silent headphones for the same duration to ensure similarity across groups, Randomization description: Eligible neonates, after obtaining written informed consent from their parents, will be randomly assigned into three groups: binaural music (A), maternal lullaby (B), and control (C). Randomization will be performed using stratified permuted block randomization with Random Allocation software. A pre-prepared randomization list will be generated by the principal investigator. Sampling will continue until the required number is completed, with 60 neonates distributed equally (20 in each group, Blinding description: This study will be conducted using a triple-blind design. The intervention provider, the outcome assessor (research assistant responsible for recording physiological indicators and scoring the videos), and the statistical analyst will all remain unaware of group allocation (binaural music, maternal lullaby, or neutral control sound). Audio files will be coded as X, Y, and Z, and only the code custodian will have access to the actual intervention type. To minimize the risk of unblinding, the control group will receive a neutral, uniform sound at the same decibel intensity as the other groups, ensuring that the intervention conditions appear identical across groups. In addition, upon completion of the study and in line with ethical principles, relaxing music educational files will be provided virtually to the parents of infants in the control group. N/A Term newborns admitted to intensive care units. Intervention 1: Intervention Group 1: Binaural Music, Infants in this group will receive binaural music from 10 minutes before the tracheal suctioning procedure until 10 minutes after it. The music will be played through standard headphones at a controlled sound intensity of 35–45 dB. The selected binaural beat music has a frequency of 10 Hz in the alpha wave range (produced by Miracle Tones and streamed via Spotify). The sound level will be measured and adjusted using the Sound Meter Pro application to ensure it remains within a safe range. Intervention 2: Intervention group 2: Mother’s Recorded Lullaby, Infants in this group will listen to their mother’s recorded lullaby from 10 minutes before the tracheal suctioning procedure until 10 minutes after it. The lullaby is recorded in a quiet room, preferably the one sung by the mother during pregnancy or intended for the infant. If a suitable room is not available in the ward, the mother may record the lullaby at home following the researcher’s guidance. The recorded lullaby will be played through standard headphones at a controlled sound intensity of 35–45 dB, verified and adjusted prior to the intervention. Intervention 3: Control group: Headphones without Sound,Infants in this group will have standard headphones placed on their ears without any sound being played, from 10 minutes before until 10 minutes after the tracheal suctioning procedure. This is to provide the same environmental condition as the intervention groups while preventing the influence of external noise. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of participants
public Maryam Paran
Nursing Faculty, Namazi Square, Blvd Zand, Shiraz town
Shiraz Iran (Islamic Republic of) 3117-31331 56317161736 paran90@gmail.com Shiraz University of Medical Sciences scientific Ms.Maryam Paran
Nursing Faculty, Namazi Square, Blvd Zand, Shiraz town, Iran
Shiraz Iran (Islamic Republic of) 63117-31331 56317161736 mparan90@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Instability of the infant's physiological status or any other systemic disorder Having an endotracheal tube Need for endotracheal suctioning Gestational age between 38 and 42 weeks Postnatal age 1 to 28 days Do not use sedatives 4 hours before suctioning. Confirmation of hearing ability in infants and response to sound stimuli (examination will be performed by a doctor) Absence of congenital anomalies, intracranial hemorrhage greater than grade 2, or neurological problems No invasive procedure for the infant at least 30 minutes before the intervention No substance abuse or use of sedatives by the mother 1 day 28 days Both Parents' unwillingness to continue cooperating during the research Instability of the infant's physiological status or any other systemic disorder P05.14 Newborn small for gestational age, 1000-1249 grams Treatment - Other Treatment - Other Treatment - Other Intervention Group 1: Binaural Music, Infants in this group will receive binaural music from 10 minutes before the tracheal suctioning procedure until 10 minutes after it. The music will be played through standard headphones at a controlled sound intensity of 35–45 dB. The selected binaural beat music has a frequency of 10 Hz in the alpha wave range (produced by Miracle Tones and streamed via Spotify). The sound level will be measured and adjusted using the Sound Meter Pro application to ensure it remains within a safe range. Intervention group 2: Mother’s Recorded Lullaby, Infants in this group will listen to their mother’s recorded lullaby from 10 minutes before the tracheal suctioning procedure until 10 minutes after it. The lullaby is recorded in a quiet room, preferably the one sung by the mother during pregnancy or intended for the infant. If a suitable room is not available in the ward, the mother may record the lullaby at home following the researcher’s guidance. The recorded lullaby will be played through standard headphones at a controlled sound intensity of 35–45 dB, verified and adjusted prior to the intervention. Control group: Headphones without Sound,Infants in this group will have standard headphones placed on their ears without any sound being played, from 10 minutes before until 10 minutes after the tracheal suctioning procedure. This is to provide the same environmental condition as the intervention groups while preventing the influence of external noise. Reduction of neonatal pain intensity during and after suction. Timepoint: 10 minutes before suction, during suction (catheter insertion), and 10 minutes after suction. Method of measurement: Neonatal Infant Pain Scale (NIPS) based on video recordings assessed by a trained assistant. Changes in physiological indices (heart rate, oxygen saturation). Timepoint: minutes before suction, during suction (catheter insertion), and 10 minutes after suction. Method of measurement: Recording of heart rate and oxygen saturation using a calibrated monitor and pulse oximeter. Shiraz University of Medical Sciences Approved 2025-08-02 Shiraz University of Medical Sciences, Shiraz University of Medical Sciences Research Committee, Fac Building No. 2, Hazrat Fatima College of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)