Maternal Voice Versus White Noise in Pediatric Surgery

NCT07785297 | Completed

• 1 other identifier: 2023/361
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study will evaluate the effects of maternal voice and white noise on postoperative pain, comfort, and physiological parameters in children aged 1 month to 3 years during the early postoperative period. The study will also compare the effectiveness of maternal voice and white noise in improving these outcomes.

Conditions

Physiological Parameters; Comfort; Children; Postoperative Pain

Keywords

Pediatric surgery; Maternal voice; White noise; Pain management; Comfort

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Assessed Using the Face, Legs, Activity, Cry, and Consolability Scale

  Postoperative pain was assessed using the Face, Legs, Activity, Cry, and Consolability Scale. The scale evaluates five behavioral domains: facial expression, leg movement, activity, crying, and consolability. Each domain is scored from 0 to 2, producing a total score ranging from 0 to 10. Higher scores indicate greater postoperative pain and therefore a worse outcome. The scale was administered at 30 and 60 minutes. The prespecified primary endpoint was the total score at 60 minutes.

  30 and 60 minutes after admission to the pediatric surgery ward

Secondary Outcomes (4)

• Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score

  30 and 60 minutes after admission to the pediatric surgery ward

• Heart Rate

  Immediately after admission and before the intervention, and at 30 and 60 minutes

• Respiratory Rate

  Immediately after admission and before the intervention, and at 30 and 60 minutes

• Peripheral Oxygen Saturation

  Immediately after admission and before the intervention, and at 30 and 60 minutes

Study Arms (3)

Maternal voice

EXPERIMENTAL

Children received routine postoperative nursing care and listened continuously for 60 minutes to a preoperatively recorded lullaby sung by their mother. Playback began after baseline physiological measurements following admission to the pediatric surgery ward. The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels.

Other: Maternal Voice Recording

White noise

EXPERIMENTAL

Children received routine postoperative nursing care and listened continuously to a standardized white noise recording for 60 minutes. Playback began after baseline physiological measurements following admission to the pediatric surgery ward. The recording was played through a portable speaker positioned at the head of the child's bed at ear level, with the sound intensity maintained at 50-55 decibels.

Other: White Noise Recording

Control Arm

NO INTERVENTION

Children received routine postoperative nursing care without a structured auditory intervention. No planned silence or sound restriction was imposed, and the children remained in the usual auditory environment of the pediatric surgery ward. Outcome assessments were conducted at the same time points as in the intervention groups.

Interventions

Maternal Voice Recording OTHER

Before surgery, each mother selected and recorded a lullaby in a quiet room with guidance from the researcher. Following postoperative admission to the pediatric surgery ward, the recording was played continuously to the child for 60 minutes through a portable speaker. Sound intensity was monitored using a calibrated sound-level meter and maintained at 50-55 decibels.

Maternal voice

White Noise Recording OTHER

Children listened to the standardized recording "Don't Let Your Baby Cry 2" from the album "Colic." The recording included intrauterine-like sounds, white-noise frequency components, and accompanying music. It was played continuously for 60 minutes through a portable speaker. Sound intensity was monitored using a calibrated sound-level meter and maintained at 50-55 decibels.

White noise

Eligibility Criteria

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

You may qualify if:

• Aged 1 to 3 years
• Scheduled to undergo an elective minor surgical procedure, such as orchiopexy, hypospadias repair, or hernia repair
• Undergoing surgery under general anesthesia with an anesthesia duration not exceeding 60 minutes
• No known hearing impairment
• No anatomical abnormality of the ear
• No chronic condition that could affect auditory perception or pain response, such as cerebral palsy, Down syndrome, or another neurodevelopmental disorder
• Scheduled for direct transfer to the pediatric surgery ward after surgery without an extended stay in the postanesthesia care unit
• Written informed consent provided by a parent or legal guardian

You may not qualify if:

• Surgery performed under emergency conditions
• A surgical procedure different from the planned procedure
• Anesthesia duration exceeding 60 minutes
• Development of a postoperative complication requiring admission to the postanesthesia care unit or intensive care unit
• Administration of additional analgesic medication beyond the institutional analgesia protocol
• Interruption or inability to complete the 60-minute auditory intervention or observation period
• Withdrawal of consent by the parent or legal guardian

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, İ̇zmi̇t, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: August 25, 2026
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)