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White Noise and Buzzy for Reducing Pain During Infant Vaccination

NCT07286721 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-12-23

No results posted yet for this study

Summary

This randomized controlled trial aims to evaluate the effectiveness of two non-pharmacological methods-white noise and the Buzzy device-in reducing pain experienced by infants during routine vaccination. Infants are known to feel pain, and untreated or poorly managed pain during early life may lead to negative short- and long-term outcomes. Therefore, identifying effective, safe, and easy-to-apply pain-reducing strategies is essential for improving infant comfort and supporting evidence-based nursing practices.

Conditions

  • Infant Pain Management

Interventions

OTHER

Standard Care (in control arm)

White noise will be played 1-2 minutes before vaccination and continued throughout the procedure. The device will be placed within safe hearing distance of the infant. This auditory distraction method is intended to reduce procedural pain. No physical stimulation will be applied. The Buzzy device will be placed about 3 cm above the injection site 60 seconds before vaccination and kept active until the procedure ends. The device provides vibration and cold stimulation to decrease pain by activating competing sensory pathways. Infants in the control arm will receive routine vaccination with no additional intervention. No white noise, vibration, or cold stimulation will be used. Pain will be assessed according to standard observation procedures.

Sponsors & Collaborators

  • Istanbul Arel University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-25
Primary Completion
2026-04-01
Completion
2026-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286721 on ClinicalTrials.gov