NCT07453641

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 2, 2026

Last Update Submit

March 15, 2026

Conditions

White Noise

Keywords

InfantWhite NoiseInvasive ProceduresCryPain

Outcome Measures

Primary Outcomes (1)

  • Crying Duration

    Immediately after each invasive procedure (0-5 minutes)

Study Arms (2)

White Noise Group

EXPERIMENTAL
Behavioral: White Noise Audio

No White Noise Group

NO INTERVENTION

Interventions

White Noise AudioBEHAVIORAL

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.

White Noise Group

Eligibility Criteria

Age1 Month - 3 Months
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

CryingPain

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Esin YILDIZ ALDEMİR, MD, PhD

CONTACT

+905324859556aldemiresin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

January 1, 2026

Primary Completion

March 15, 2026

Study Completion

April 15, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)