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Completed

NCT Number: NCT07785297

Maternal Voice Versus White Noise in Pediatric Surgery

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.

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Key information

Conditions

Children Agnosia Comfort Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Physiological Parameters Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, İ̇zmi̇t, Turkey (Türkiye)

About this study

For the maternal voice intervention, the mother will select a lullaby, and its lyrics will be provided to her by the researcher. The lullaby will be recorded in the mother's voice with the assistance of the researcher. The sound level of the recording will be adjusted to approximately 50 decibels. Children assigned to the maternal voice group will listen to the recorded lullaby during the early postoperative period. A copy of the recording will be provided to the mother after completion of the study.

Children assigned to the white noise group will listen to the white noise recording "Don't Let Your Baby Cry 2" from the album "Colic." The recording includes intrauterine-like and white-noise sounds combined with music. The recording will be used after obtaining the necessary permissions from the relevant copyright holders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 30 and 60 minutes after admission to the pediatric surgery ward

    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.

Secondary outcomes

  1. Postoperative Recovery Assessed Using the Modified Aldrete Recovery Score

    Time frame: 30 and 60 minutes after admission to the pediatric surgery ward

    Postoperative recovery was assessed using the Modified Aldrete Recovery Score. The scale evaluates five domains: motor activity, respiration, circulation, consciousness, and peripheral oxygen saturation. Each domain is scored from 0 to 2, producing a total score ranging from 0 to 10. Higher scores indicate a better level of postoperative recovery. A score of 9 or higher generally indicates readiness for discharge from postanesthesia care. The scale was administered at 30 and 60 minutes. The prespecified secondary endpoint was the total score at 60 minutes.

  2. Heart Rate

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

    Heart rate was measured using a pulse oximeter and recorded as beats per minute. Lower values within the age-appropriate physiological range indicate reduced physiological arousal; however, the measure does not have a predefined better or worse direction independently of the clinical context.

  3. Respiratory Rate

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

    Respiratory rate was recorded as breaths per minute. Lower values within the age-appropriate physiological range may indicate reduced physiological arousal; however, the measure does not have a predefined better or worse direction independently of the clinical context.

  4. Peripheral Oxygen Saturation

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

    Peripheral oxygen saturation was measured using a pulse oximeter and recorded as a percentage. Higher values within the clinically expected range indicate better oxygenation.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Maternal Voice Versus White Noise: Effects on Pain, Comfort, and Physiological Responses in Pediatric Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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