Effects of White Noise and Lullaby on Vital Signs of Term Newborns in Neonatal Intensive Care

NCT07590479 | Completed DMC

• 1 other identifier: 08.09.2025-39
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to evaluate how two types of gentle sounds - white noise and a traditional Turkish lullaby ("Dandini Dandini Dastana") - affect the vital signs of term newborns cared for in the Neonatal Intensive Care Unit (NICU). The first weeks of life are critical for newborns, especially those who need special care in the NICU. During this time, maintaining physiological stability-such as normal heart rate, breathing rate, and oxygen levels-is essential. In addition to medical treatments, non-pharmacological interventions like music and soothing sounds are increasingly used to reduce stress and support comfort. In this randomized controlled study, 70 term newborns (born after 37 weeks of gestation and weighing at least 2500 grams) were randomly assigned to one of two groups:

• White Noise Group: infants listened to a digitally recorded white noise (imitating intrauterine sound patterns) for 20 minutes.
• Lullaby Group: infants listened to a recording of the traditional lullaby "Dandini Dandini Dastana" for the same duration. Both interventions were administered three times a day for four consecutive days in a calm NICU environment. The sound level was carefully calibrated not to exceed 55 decibels (dBA), ensuring safety for newborn hearing. Researchers measured heart rate, respiratory rate, and oxygen saturation (SpO₂) at baseline and at the 5th, 10th, 15th, and 20th minutes during each session. Results showed that both white noise and lullaby sessions led to a gradual decrease in heart rate, while breathing rate and oxygen levels remained stable. No adverse events or signs of physiological instability were observed. These findings suggest that both white noise and lullaby listening are safe, low-cost, and effective supportive methods for helping term newborns remain calm and physiologically stable during intensive care. The study contributes to growing evidence that structured auditory stimulation can help promote comfort and self-regulation in newborns without the need for medication.

Conditions

Neonates; White Noise; Auditory; Non-Pharmacological Interventions

Keywords

White noise; Lullaby; Term newborn; Neonatal intensive care unit (NICU); Physiological stability; Heart rate variability; Oxygen saturation (SpO2); Respiratory rate; Auditory stimulation; Non-pharmacological intervention; Supportive care

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate (beats per minute) from Baseline to 20th Minute During Intervention Session

  Heart rate (beats per minute) was continuously monitored using bedside patient monitors (Dräger, Germany). The primary endpoint is the within-session change in heart rate from baseline to the 20th minute, averaged across all sessions over four days. The measure assesses the acute physiological calming effect of auditory stimulation (white noise or lullaby) in term newborns.

  Change from baseline to 20 minutes, averaged across intervention sessions over 4 days.

Secondary Outcomes (2)

• Change in Oxygen Saturation (SpO₂, %) from Baseline to 20th Minute During Intervention Session

  Change from baseline to 20 minutes, averaged across intervention sessions over 4 days.

• Incidence of Adverse Events During or Immediately After Intervention Sessions

  During intervention and up to 30 minutes post-intervention, over 4 days.

Study Arms (2)

White Noise Group

EXPERIMENTAL

Term newborns received a standardized white noise recording representing intrauterine sound characteristics ("Colic" album, Osman Orhan). Each session lasted 20 minutes, conducted three times daily (at 11:00, 14:00, and 17:00) for four consecutive days. The sound level was calibrated to a maximum of 55 dBA at the infant's ear level. Heart rate, respiratory rate, and oxygen saturation were recorded at baseline and at the 5th, 10th, 15th, and 20th minutes during each session.

Behavioral: White Noise Exposure

Lullaby Group

EXPERIMENTAL

Term newborns listened to a digital recording of the traditional Turkish lullaby "Dandini Dandini Dastana." Each session lasted 20 minutes, conducted three times daily (at 11:00, 14:00, and 17:00) for four consecutive days, under identical environmental conditions as the white noise group. The sound intensity was standardized not to exceed 55 dBA. Vital signs (heart rate, respiratory rate, oxygen saturation) were monitored at baseline and throughout the session.

Behavioral: Lullaby Listening

Interventions

White Noise Exposure BEHAVIORAL

Participants listened to a digitally recorded standardized white noise stimulus mimicking intrauterine sound characteristics. Each session lasted 20 minutes and was conducted three times daily (at 11:00, 14:00, and 17:00) for four consecutive days in the neonatal intensive care unit. The sound level was measured and calibrated before each session to a maximum of 55 dBA at the infant's ear level using a decibel meter (Wintact WT85). Heart rate, respiratory rate, and oxygen saturation were monitored at baseline and during the session. The intervention was administered under stable clinical conditions after routine care.

White Noise Group

Lullaby Listening BEHAVIORAL

Participants listened to a digital recording of the traditional Turkish lullaby "Dandini Dandini Dastana." Sessions lasted 20 minutes and were conducted three times daily (11:00, 14:00, 17:00) for four consecutive days in the neonatal intensive care unit, identical to the white noise schedule. The sound intensity was standardized to a maximum of 55 dBA. Vital parameters (heart rate, respiratory rate, oxygen saturation) were recorded at baseline and at 5, 10, 15, and 20 minutes during each session. The intervention aimed to promote relaxation and physiological stability in term newborns.

Lullaby Group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≥ 37 completed weeks
• Birth weight ≥ 2500 grams
• Postnatal age between 0 and 28 days at enrollment
• Admitted to the neonatal intensive care unit (NICU) for any medical reason
• Spontaneous breathing (not intubated)
• No current sedative or analgesic medication
• Written informed consent obtained from parents or legal guardians

You may not qualify if:

• Gestational age \< 37 weeks (preterm infants)
• Birth weight \< 2500 grams
• Congenital hearing loss or major congenital anomaly
• History of seizures or intracranial hemorrhage
• Requirement for mechanical ventilation
• Current use of sedative or analgesic drugs
• Early discharge or death before completion of the intervention protocol
• Parental refusal or withdrawal of consent during study procedures

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Nevin Cambaz Kurt, MD, Assoc. Prof.

  TC Health Sciences University, Basaksehir Cam and Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the auditory interventions, participants and care providers were not blinded. However, physiological data (heart rate, respiratory rate, SpO₂) were extracted automatically from monitor systems and analyzed using group-coded datasets (Group A / Group B). The outcome assessor and statistician remained blinded until the completion of data analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel-group randomized controlled trial. Participants (term newborns) were assigned in a 1:1 ratio to receive either standardized white noise or lullaby exposure. Each intervention was applied three times daily for four consecutive days in the neonatal intensive care unit.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: May 15, 2026
• Study Start: September 30, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: May 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)