FindTrial
Sign In

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250820066925N1
Enrollment
51
Registered
2025-09-20
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Term newborns admitted to intensive care units. Newborn small for gestational age, 1000-1249 grams

Interventions

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 wi

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 28 Days

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Parents' unwillingness to continue cooperating during the research Instability of the infant's physiological status or any other systemic disorder

Design outcomes

Primary

MeasureTime frame
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.—

Secondary

MeasureTime frame
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.—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Paran

Shiraz University of Medical Sciences

paran90@gmail.com56317161736

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026