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

NCT07753486 | Not Yet Recruiting

• 1 other identifier: 2025/607
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Maternal Voice; Pediatric Intensive Care Unite; Physiological Parameters; COMFORT Scale; Non-pharmacological Intervention

Outcome Measures

Primary Outcomes (1)

• COMFORT Scale Score

  The COMFORT Scale assesses pain and sedation level in critically ill children based on alertness, calmness, respiratory response, physical movement, blood pressure, heart rate, muscle tone, and facial tension. 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

Study Arms (2)

Maternal Voice Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

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?

Maternal Voice Intervention Group

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MERAL BAYAT, PhD

  TC Erciyes University

  STUDY CHAIR

Central Study Contacts

GAMZE NUR GÜZEL, RN

CONTACT

+905535664246; gmznrgzl446@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Model Details: Participants were randomized into two parallel groups: an intervention group receiving recorded maternal voice and a control group receiving standard unit care, assessed concurrently.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)