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

NCT07753486 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-08-10

No results posted yet for this 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.

Conditions

  • Pain
  • Sedation
  • Mechanical Ventilation

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?

Sponsors & Collaborators

  • TC Erciyes University

    lead OTHER

Principal Investigators

  • MERAL BAYAT, PhD · TC Erciyes University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2026-12-15
Completion
2026-12-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07753486 on ClinicalTrials.gov