White Noise and Crying Duration After Invasive Procedures... | NCT07453641

Studies
White Noise and Crying Duration After Invasive Procedures in Infants

NCT07453641

Sponsor

Başakşehir Çam & Sakura City Hospital

Status

Recruiting

Last Update Posted

Mar 17, 2026Actual

Enrollment

37Estimated

Phase

Not Applicable

Conditions

White Noise

Interventions

White Noise Audio

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Actual

Primary Completion Date

Mar 15, 2026Actual

Completion Date

Apr 15, 2026Estimated

First Submitted Date

Mar 2, 2026

First Submission Date that Met QC Criteria

Mar 2, 2026

First Posted Date

Mar 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2026

Last Update Posted Date

Mar 17, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Şeymanur Uçum, MD, Başakşehir Çam & Sakura City HospitalPrincipal Investigator

Lead Sponsor

Başakşehir Çam & Sakura City HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
White Noise Group	Experimental		Behavioral: White Noise Audio
No White Noise Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
White Noise Audio	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Crying Duration		Immediately after each invasive procedure (0-5 minutes)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

3 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Esin YILDIZ ALDEMİR, MD, PhD	Contact	+905324859556		aldemiresin@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Basaksehir Cam ve Sakura City Hospital	Recruiting	Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003448	Crying
D010146	Pain

Ancestor Terms

ID	Term
D009633	Nonverbal Communication
D003142	Communication
D001519	Behavior
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.