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Clinical Trials/NCT07453641
NCT07453641RecruitingNot Applicable

The Effect of White Noise on Crying Duration After Invasive Procedures in Infants Aged 1-3 Months

Başakşehir Çam & Sakura City Hospital1 site in 1 country37 target enrollmentStarted: January 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
37
Locations
1
Primary Endpoint
Crying Duration

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
1 Month to 3 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

White Noise Group

Experimental

Intervention: White Noise Audio (Behavioral)

No White Noise Group

No Intervention

Outcomes

Primary Outcomes

Crying Duration

Time Frame: Immediately after each invasive procedure (0-5 minutes)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Başakşehir Çam & Sakura City Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Şeymanur Uçum

MD

Başakşehir Çam & Sakura City Hospital

Study Sites (1)

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