White NoiseNCT07453641
White Noise and Crying Duration After Invasive Procedures in Infants
A study testing White Noise Audio in people with White Noise, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of white noise applied during invasive procedures (blood sampling or intravenous access) on pain and physical parameters in infants aged 1-3 months. Read more about this study
- Who is it for?
- Ages 1 month to 3 months
- Conditions the study is for
- White Noise
- What is being tested?
- White Noise Audio
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 1-3 months
- Born at term (≥37 weeks gestational age)
- Admitted to the general pediatric ward
- Scheduled for routine invasive procedures such as venipuncture or intravenous line placement
Who cannot join
- Infants with congenital anomalies
- Infants with hearing impairments
- Infants with a history of analgesic or pain-relieving medication use prior to the invasive procedure
- Infants requiring intensive care unit (ICU) monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Basaksehir Cam ve Sakura City Hospital
Istanbul
About this study
Official title: The Effect of White Noise on Crying Duration After Invasive Procedures in Infants Aged 1-3 Months
The aim of this study is to evaluate the effect of white noise applied during invasive procedures (blood sampling or intravenous access) on pain and physical parameters in infants aged 1-3 months.
Read the detailed description
White noise is a monotonous sound that mimics the intrauterine environment, protecting the baby from environmental noise and having a calming effect. The findings may demonstrate the effectiveness of white noise among non-pharmacological approaches to pain management in infants and may offer healthcare professionals an applicable intervention method. If the pain and stress-reducing effects of white noise are proven, its use in routine care could be expanded. There are no known side effects associated with white noise application. There is no risk beyond that of a normal blood draw during the procedure.
- Conditions
- White Noise
- Being tested
- White Noise Audio
- Keywords
- Infant, White Noise, Invasive Procedures, Cry, Pain
- Medical subject headings
- Crying, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Noise AudioBehavioural
Infants undergo routine invasive procedures while continuous white noise audio is played through speakers. Crying duration is measured immediately after each procedure to evaluate the effect of white noise on procedural distress.
| Study group | Role | What they receive |
|---|---|---|
| White Noise Group | Experimental | Not described Receives: Behavioral: White Noise Audio |
| No White Noise Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crying Duration
Measured: Immediately after each invasive procedure (0-5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jan 2026
- Primary completion15 Mar 2026
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White NoiseStudies 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
- Crossover
- Model description
- This is a single-center, randomized, crossover study in which each infant undergoes invasive procedures under two conditions: with white noise and without white noise. Crying duration is measured after each procedure to assess the effect of white noise.
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Şeymanur Uçum, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453641
- Sponsor's protocol ID
- BCSSH-SBU-ŞU-11
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of White Noise on Crying Duration After Invasive Procedures in Infants Aged 1-3 Months
- ClinicalTrials.gov ID
- NCT07453641
- Acronym / sponsor ID
- BCSSH-SBU-ŞU-11
- Conditions
- White Noise
- Keywords
- Infant, White Noise, Invasive Procedures, Cry, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 6 Mar 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.
The aim of this study is to evaluate the effect of white noise applied during invasive procedures (blood sampling or intravenous access) on pain and physical parameters in infants aged 1-3 months.
Detailed description
White noise is a monotonous sound that mimics the intrauterine environment, protecting the baby from environmental noise and having a calming effect. The findings may demonstrate the effectiveness of white noise among non-pharmacological approaches to pain management in infants and may offer healthcare professionals an applicable intervention method. If the pain and stress-reducing effects of white noise are proven, its use in routine care could be expanded. There are no known side effects associated with white noise application. There is no risk beyond that of a normal blood draw during the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, randomized, crossover study in which each infant undergoes invasive procedures under two conditions: with white noise and without white noise. Crying duration is measured after each procedure to assess the effect of white noise.
| Arm | Type | Receives |
|---|---|---|
| White Noise Group | Experimental | Behavioral: White Noise Audio |
| No White Noise Group | No intervention | – |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants aged 1-3 months
- Born at term (≥37 weeks gestational age)
- Admitted to the general pediatric ward
- Scheduled for routine invasive procedures such as venipuncture or intravenous line placement
Key exclusion criteria (4 listed)
- Infants with congenital anomalies
- Infants with hearing impairments
- Infants with a history of analgesic or pain-relieving medication use prior to the invasive procedure
- Infants requiring intensive care unit (ICU) monitoring
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 AudioInfants undergo routine invasive procedures while continuous white noise audio is played through speakers. Crying duration is measured immediately after each procedure to evaluate the effect of white noise on procedural distress. | Behavioural | White Noise Group |
Primary outcome
Crying Duration
Time frame: Immediately after each invasive procedure (0-5 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Audio in people with 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esin YILDIZ ALDEMİR, MD, PhD (+905324859556, aldemiresin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crying Duration (time frame: Immediately after each invasive procedure (0-5 minutes)). 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 17 Mar 2026.