NeonatesNCT07590479
Effects of White Noise and Lullaby on Vital Signs of Term Newborns in Neonatal Intensive Care
A study testing White Noise Exposure and Lullaby Listening in people with Neonates and White Noise, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neonates, White Noise, Non-Pharmacological Interventions
- What is being tested?
- White Noise Exposure and Lullaby Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Istanbul
About this study
Official title: Comparison of the Effects of White Noise and Lullaby on Vital Parameters in Term Infants Hospitalized in the Neonatal Intensive Care Unit: A Controlled Randomized Study
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.
Read more
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.
Read the detailed description
Background and Rationale: Newborns admitted to the Neonatal Intensive Care Unit (NICU) are frequently exposed to environmental stressors that may disrupt autonomic stability. Developmental care strategies increasingly incorporate sensory modulation approaches to support physiological regulation. Auditory stimulation, including white noise and lullabies, has shown potential to reduce stress responses and promote behavioral organization. However, comparative evidence in term newborns remains limited, as most studies have focused on preterm populations. This study was designed to evaluate and compare the short-term physiological effects of two standardized auditory interventions-white noise and lullaby exposure-in term newborns under controlled NICU conditions.
Study Design and Setting: This was a prospective, multicenter, parallel-group randomized controlled trial conducted in two tertiary NICUs in Türkiye. Participants were randomized in a 1:1 ratio using stratified block randomization by center, with allocation concealment ensured through sealed opaque envelopes.
Intervention Protocols: Both interventions were delivered in a standardized manner to minimize environmental variability. Auditory stimulation sessions lasted 20 minutes and were administered three times daily over four consecutive days. Sound intensity was calibrated prior to each session and maintained below 55 dBA to ensure auditory safety. White noise exposure consisted of a digitally standardized recording simulating intrauterine acoustic patterns. The lullaby intervention consisted of a culturally familiar, standardized digital recording. All sessions were conducted during stable clinical conditions and scheduled to avoid routine caregiving activities. The playback device was a portable MP3 player with a 3-5 W speaker placed approximately 50 cm from the infant's ear. Sound intensity was measured before each session using a Wintact WT85 decibel meter, maintaining a maximum of 55 dBA (A-weighted). Sessions were conducted during quiet periods after routine care and feeding to minimize external stressors.
Data Collection and Measurements: Physiological parameters were obtained using continuous bedside monitoring systems. Heart rate and oxygen saturation were automatically recorded, while respiratory rate was assessed using standardized observation methods. Repeated measurements within sessions enabled evaluation of temporal trends and within-subject variability.
Statistical Analysis: The primary analytical approach utilized linear mixed-effects models to account for repeated measurements within individuals. Fixed effects included intervention group, time, and group-by-time interaction, while random intercepts accounted for within-subject correlation. Baseline values and study center were included as covariates. Sensitivity analyses were performed to assess the robustness of the findings.
Ethical Considerations: The study was approved by the institutional ethics committee, and written informed consent was obtained from parents or legal guardians prior to enrollment. All procedures were conducted in accordance with the Declaration of Helsinki.
- Conditions
- Neonates, White Noise, Non-Pharmacological Interventions, Auditory
- Being tested
- White Noise Exposure, Lullaby Listening
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Noise ExposureBehavioural
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.
Lullaby ListeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Lullaby Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Peripheral oxygen saturation (SpO₂, %) was continuously recorded using pulse oximetry as part of bedside monitoring. The outcome assesses maintenance of oxygenation and physiological safety during auditory stimulation in term newborns.
Measured: Change from baseline to 20 minutes, averaged across intervention sessions over 4 days.
Incidence of Adverse Events During or Immediately After Intervention Sessions
Any clinically significant event (e.g., desaturation, apnea, bradycardia, or need for clinical intervention) occurring during or immediately after a session was documented according to NICU safety protocols. This outcome assesses the tolerability and safety of auditory stimulation.
Measured: During intervention and up to 30 minutes post-intervention, over 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start30 Sep 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nevin Cambaz Kurt, MD, Assoc. Prof., Principal investigator, TC Health Sciences University, Basaksehir Cam and Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590479
- Sponsor's protocol ID
- 08.09.2025-39
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the inclusion of neonatal participants and the sensitive nature of clinical data collected in intensive care settings. Only aggregated, de-identified summary data will be reported in publications and conference presentations. Data sharing beyond these summaries is restricted by institutional ethics approval and parental consent limitations.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of White Noise and Lullaby on Vital Parameters in Term Infants Hospitalized in the Neonatal Intensive Care Unit: A Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT07590479
- Acronym / sponsor ID
- 08.09.2025-39
- Conditions
- Neonates, White Noise, Non-Pharmacological Interventions, Auditory
- Keywords
- White noise, Lullaby, Term newborn, Neonatal intensive care unit (NICU), Physiological stability, Heart rate variability, Oxygen saturation (SpO2), Respiratory rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale: Newborns admitted to the Neonatal Intensive Care Unit (NICU) are frequently exposed to environmental stressors that may disrupt autonomic stability. Developmental care strategies increasingly incorporate sensory modulation approaches to support physiological regulation. Auditory stimulation, including white noise and lullabies, has shown potential to reduce stress responses and promote behavioral organization. However, comparative evidence in term newborns remains limited, as most studies have focused on preterm populations. This study was designed to evaluate and compare the short-term physiological effects of two standardized auditory interventions-white noise and lullaby exposure-in term newborns under controlled NICU conditions.
Study Design and Setting: This was a prospective, multicenter, parallel-group randomized controlled trial conducted in two tertiary NICUs in Türkiye. Participants were randomized in a 1:1 ratio using stratified block randomization by center, with allocation concealment ensured through sealed opaque envelopes.
Intervention Protocols: Both interventions were delivered in a standardized manner to minimize environmental variability. Auditory stimulation sessions lasted 20 minutes and were administered three times daily over four consecutive days. Sound intensity was calibrated prior to each session and maintained below 55 dBA to ensure auditory safety. White noise exposure consisted of a digitally standardized recording simulating intrauterine acoustic patterns. The lullaby intervention consisted of a culturally familiar, standardized digital recording. All sessions were conducted during stable clinical conditions and scheduled to avoid routine caregiving activities. The playback device was a portable MP3 player with a 3-5 W speaker placed approximately 50 cm from the infant's ear. Sound intensity was measured before each session using a Wintact WT85 decibel meter, maintaining a maximum of 55 dBA (A-weighted). Sessions were conducted during quiet periods after routine care and feeding to minimize external stressors.
Data Collection and Measurements: Physiological parameters were obtained using continuous bedside monitoring systems. Heart rate and oxygen saturation were automatically recorded, while respiratory rate was assessed using standardized observation methods. Repeated measurements within sessions enabled evaluation of temporal trends and within-subject variability.
Statistical Analysis: The primary analytical approach utilized linear mixed-effects models to account for repeated measurements within individuals. Fixed effects included intervention group, time, and group-by-time interaction, while random intercepts accounted for within-subject correlation. Baseline values and study center were included as covariates. Sensitivity analyses were performed to assess the robustness of the findings.
Ethical Considerations: The study was approved by the institutional ethics committee, and written informed consent was obtained from parents or legal guardians prior to enrollment. All procedures were conducted in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| White Noise Group | Experimental | Behavioral: White Noise ExposureTerm 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. |
| Lullaby Group | Experimental | Behavioral: Lullaby ListeningTerm 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. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White Noise ExposureParticipants 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. | Behavioural | White Noise Group |
| Lullaby ListeningParticipants 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. | Behavioural | Lullaby Group |
Primary outcome
Change in Heart Rate (beats per minute) from Baseline to 20th Minute During Intervention Session
Time frame: Change from baseline to 20 minutes, averaged across intervention sessions over 4 days.
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.
2 secondary outcomes
Change in Oxygen Saturation (SpO₂, %) from Baseline to 20th Minute During Intervention Session
Time frame: Change from baseline to 20 minutes, averaged across intervention sessions over 4 days.
Incidence of Adverse Events During or Immediately After Intervention Sessions
Time frame: During intervention and up to 30 minutes post-intervention, over 4 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the inclusion of neonatal participants and the sensitive nature of clinical data collected in intensive care settings. Only aggregated, de-identified summary data will be reported in publications and conference presentations. Data sharing beyond these summaries is restricted by institutional ethics approval and parental consent limitations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevin Cambaz Kurt, MD, Assoc. Prof. principal investigator
TC Health Sciences University, Basaksehir Cam and Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Noise Exposure and Lullaby Listening in people with Neonates and White Noise, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate (beats per minute) from Baseline to 20th Minute During Intervention Session (time frame: Change from baseline to 20 minutes, averaged across intervention sessions over 4 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.