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

August 6, 2026 updated by: Gamze Nur Güzel, TC Erciyes University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial will be conducted in the Pediatric Intensive Care Unit (PICU) of Kayseri City Hospital. Eligible children (aged 1-3 years, intubated, mechanically ventilated, and sedated, with no change in sedation dose in the prior 24 hours) will be assigned to an intervention or control group using stratified block randomization (stratified by age, sex, diagnosis duration, and COMFORT scale score), with simple randomization within blocks performed by an independent researcher.

In the intervention group, each child's mother will be asked to read a children's storybook aloud in a quiet room, and this reading will be recorded (approximately 10 minutes). The recording will then be played to the child once, through wireless over-ear headphones at a safe volume (50-55 dB), during a single morning session. The COMFORT Scale and physiological parameters (heart rate, oxygen saturation, blood pressure, respiratory rate) will be assessed before, during, and after the recording is played. All sessions will be video recorded so that COMFORT Scale scores can also be scored by independent, blinded observers.

Children in the control group will receive standard unit care with no additional intervention, and will be assessed on the same schedule and with the same tools as the intervention group.

Data will be analyzed using IBM SPSS 27.0. Group comparisons will use Chi-square, Independent/Paired Samples t-tests, or Mann-Whitney U/Wilcoxon tests as appropriate, with statistical significance set at p < 0.05.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 1-3 years, intubated and mechanically ventilated under sedation
  • No change in sedation dose within the last 24 hours
  • No hearing impairment in the child
  • Parent has no visual, hearing, or speech impairment
  • Parent is a Turkish speaker/reader with at least a primary school education
  • Parent provides written and verbal informed consent

Exclusion Criteria:

  • Children receiving care/treatment due to surgical operation or trauma
  • Children who experience cardiac arrest during the study
  • Children whose parent withdraws consent during the study
  • Children who are extubated during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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?
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The COMFORT Scale (full behavioral and physiological scale for assessing pain and sedation level in critically ill children) assesses eight items - alertness, calmness, respiratory response, physical movement, blood pressure, heart rate, muscle tone, and facial tension - each scored 1 to 5, yielding a total score ranging from 8 (minimum) to 40 (maximum). Higher scores indicate greater distress/pain and inadequate sedation, while lower scores indicate deeper sedation and better comfort. Scores will be compared between the maternal voice intervention group and the control group.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Study Chair: MERAL BAYAT, PhD, TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 7, 2026

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared, as this is a single-center thesis study involving a vulnerable pediatric population, and no data sharing infrastructure or consent for external data sharing was established as part of the study protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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