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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from TC Erciyes University

Record History

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  1. Primary endpoint(s) modifiedv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07753486
Lead Sponsor TC Erciyes University
Conditions
(from sponsor)		 Pain, Sedation, Mechanical Ventilation
Related terms Pain
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov