Clinical Research Directory
Browse clinical research sites, groups, and studies.
White Noise and Buzzy for Reducing Pain During Infant Vaccination
Sponsor: Istanbul Arel University
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.
Official title: The Effect of White Noise and Buzzy Use on Pain During Infant Vaccination: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
2 Months - 6 Months
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2025-09-25
Completion Date
2026-06-01
Last Updated
2025-12-23
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Büyükçekmece Central Family Health Center
Istanbul, Istanbul, Turkey (Türkiye)