Pain / painful procedure. Preterm [premature] newborn [other]
Conditions
Interventions
Intervention 1: In this study, the intervention consists of delivering Simulated Intrauterine Sounds to preterm infants admitted to the NICU. These sounds are provided using a calibrated and standardi
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
7 Months to 9 Months
Inclusion criteria
Inclusion criteria: Late preterm infants, with a gestational age of 34 full weeks to 36 weeks and 6 days Having a stable clinical condition as determined by a neonatologist Absence of any known life-threatening diseases, major congenital anomalies, or diagnosed hearing impairments No need for invasive mechanical ventilation
Exclusion criteria
Exclusion criteria: Sudden and acute change in the clinical condition of the infant requiring emergency intervention Initiation of sedative medications that affect the level of consciousness Parental withdrawal at any stage of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured by the total score of the Premature Infant Pain Profile Revised, following exposure to the womb sound simulator intervention. This outcome reflects behavioral and physiological responses to auditory stimulation and is considered the main indicator of the effectiveness of the intervention. The sample size of the study is calculated based on the expected change in this outcome variable. Timepoint: The primary outcome will be measured at the following time points: at baseline before the intervention, during the intervention at the thirtieth minute of sound exposure, and thirty minutes after completion of the intervention session. Measurements will be performed on each intervention day during the three consecutive days of intervention. Method of measurement: The primary outcome will be measured using the Premature Infant Pain Profile Revised, a standardized and validated clinical assessment tool. This scale evaluates pain and stress in preterm infants based on changes in heart rate, oxygen saturation, facial expressions, and gestational age, and is completed by a trained nurse or researcher through direct observation and monitoring data. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome variable is the change in physiological stability of preterm infants, defined as the mean heart rate measured during and after the intervention period, following exposure to the womb sound simulator intervention. This outcome reflects the autonomic nervous system response to auditory stimulation and is considered a supportive indicator of the calming effect of the intervention. Timepoint: At baseline before the intervention, during the intervention at the thirtieth minute of sound exposure, and thirty minutes after completion of the intervention session. Measurements will be recorded continuously using bedside monitoring and averaged for each defined time point during the three consecutive days of intervention. Method of measurement: Will be measured using continuous heart rate monitoring through a standard neonatal bedside monitoring system. Heart rate values will be extracted from the monitor records and analyzed by the research team according to predefined time intervals. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Shokraei
Shahid Beheshti University of Medical Sciences
Outcome results
None listed