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NOT YET RECRUITING
NCT07753486
NA

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

Sponsor: TC Erciyes University

View on ClinicalTrials.gov

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.

Official title: The Effect of Maternal Voice Played to Children on Mechanical Ventilators on Pain, Sedation, and Physiological Parameters: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

1 Year - 3 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-08-15

Completion Date

2026-12-15

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

BEHAVIORAL

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. Want to be notified when Claude responds?

Locations (1)

Kayseri City Hospital

Kayseri, Kayseri, Turkey (Türkiye)