Effects of White Noise and Lullaby on Vital Signs of Term Newborns in Neonatal Intensive Care
NCT07590479 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-05-15
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
- Non-Pharmacological Interventions
- Auditory
Interventions
- BEHAVIORAL
-
White Noise Exposure
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.
- BEHAVIORAL
-
Lullaby Listening
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.
Sponsors & Collaborators
-
Başakşehir Çam & Sakura City Hospital
lead OTHER_GOV
Principal Investigators
-
Nevin Cambaz Kurt, MD, Assoc. Prof. · TC Health Sciences University, Basaksehir Cam and Sakura City Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 0 Days
- Max Age
- 28 Days
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-30
- Primary Completion
- 2025-12-20
- Completion
- 2025-12-20
Countries
- Turkey (Türkiye)
Study Locations
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