White Noise and Crying Duration After Invasive Procedures in Infants

March 15, 2026 updated by: Şeymanur Uçum, Başakşehir Çam & Sakura City Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Basaksehir Çam Ve Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: White Noise Group
Behavioral: White Noise Audio
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.
No Intervention: No White Noise Group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Actual)

March 15, 2026

Study Completion (Estimated)

April 15, 2026

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCSSH-SBU-ŞU-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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