Effect of Maternal Voice on Pain, Sedation, and Physiological Parameters in Mechanically Ventilated Children

Overview

Children in the pediatric intensive care unit often experience pain and stress from medical procedures, even while sedated. This study will test whether playing a recording of the child's mother's voice helps reduce pain and the need for sedation medication in children aged 1 to 3 years who are on a breathing machine (mechanical ventilator). Children will be randomly placed into one of two groups: one group will listen to a 10-minute recording of their mother's voice through headphones, while the other group will receive usual care with no recording. Researchers will measure pain and comfort levels, heart rate, oxygen levels, blood pressure, and breathing rate before, during, and after the session to see if listening to the mother's voice makes a difference.

This randomized controlled trial will be conducted in the Pediatric Intensive Care Unit (PICU) of Kayseri City Hospital. Eligible children (aged 1-3 years, intubated, mechanically ventilated, and sedated, with no change in sedation dose in the prior 24 hours) will be assigned to an intervention or control group using stratified block randomization (stratified by age, sex, diagnosis duration, and COMFORT scale score), with simple randomization within blocks performed by an independent researcher. In the intervention group, each child's mother will be asked to read a children's storybook aloud in a quiet room, and this reading will be recorded (approximately 10 minutes). The recording will then be played to the child once, through wireless over-ear headphones at a safe volume (50-55 dB), during a single morning session. The COMFORT Scale and physiological parameters (heart rate, oxygen saturation, blood pressure, respiratory rate) will be assessed before, during, and after the recording is played. All sessions will be video recorded so that COMFORT Scale scores can also be scored by independent, blinded observers. Children in the control group will receive standard unit care with no additional intervention, and will be assessed on the same schedule and with the same tools as the intervention group. Data will be analyzed using IBM SPSS 27.0. Group comparisons will use Chi-square, Independent/Paired Samples t-tests, or Mann-Whitney U/Wilcoxon tests as appropriate, with statistical significance set at p \< 0.05.