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

Sponsor
TC Erciyes University
Study ID
NCT07753486
Status
Not Yet Recruiting

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Conditions

  • Mechanical Ventilation
  • Pain
  • Sedation

Eligibility Criteria

Sex
ALL
Age
1 Year - 3 Years
Healthy Volunteers
Not accepted

Interventions

  • Recorded Maternal Voice — BEHAVIORAL
    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?

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 15, 2026
Status verified
Aug 2026
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Maternal Voice Intervention Group
    Children received a single \~10-minute recording of their mother's voice reading a children's storybook, played once through wireless over-ear headphones at 50-55 dB during a single morning session, with no other interventions during playback.
  • No Intervention: Control Group
    Children received standard PICU care with no additional intervention. Assessments (COMFORT Scale, physiological parameters, video recording) were performed on the same schedule as the intervention group.

Primary Outcome Measure

COMFORT Scale [ Time Frame: 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 ]

Central Contacts

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