Recorded Maternal Voice: A single \~10-minute audio recording of the child's own mother reading a children's storybook ("The Invisible String," Turkish edition) will be played once through wireless over-ear headphones at a safe listening level (50-55 dB), during a single morning session (10:00-12:00), with no other procedural interventions during playback. The recording will be made in a quiet room by an independent researcher using a digital audio recorder.
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Study summary
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.
Eligibility
Sex
ALL
Min age
1 Year
Max age
3 Years
Healthy volunteers
No
Inclusion Criteria:
* Children aged 1-3 years, intubated and mechanically ventilated under sedation
* No change in sedation dose within the last 24 hours
* No hearing impairment in the child
* Parent has no visual, hearing, or speech impairment
* Parent is a Turkish speaker/reader with at least a primary school education
* Parent provides written and verbal informed consent
Exclusion Criteria:
* Children receiving care/treatment due to surgical operation or trauma
* Children who experience cardiac arrest during the study
* Children whose parent withdraws consent during the study
* Children who are extubated during the study
Primary outcome measure(s)
COMFORT Scale — Assessed before (~5 min), during (~10 min), and immediately after (~5 min) the intervention, within a single ~20-minute session on the day of enrollment The COMFORT Scale (full behavioral and physiological scale for assessing pain and sedation level in critically ill children) assesses eight items - alertness, calmness, respiratory response, physical movement, blood pressure, heart rate, muscle tone, and facial tension - each scored 1 to 5, yielding a total score ranging from 8 (minimum) to 40 (maximum). Higher scores indicate greater distress/pain and inadequate sedation, while lower scores indicate deeper sedation and better comfort. Scores will be compared between the maternal voice intervention group and the control group.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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