Clinical Trial

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

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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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-08-11
Trial Details
NCT Number NCT07753486
Lead Sponsor TC Erciyes University
Conditions Pain, Sedation, Mechanical Ventilation
Enrollment 28 participants
Start Date 2026-08-15
Primary Completion 2026-12-15 (estimated)
Study Completion 2026-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-10