Active — Not RecruitingNot Applicable

White Noise and Buzzy for Reducing Pain During Infant Vaccination

Turkey (Türkiye)108 participantsStarted 2025-09-25

Plain-language 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.

Who can participate

Age range2 Months – 6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Infants aged 2 to 6 months * Receiving routine hexavalent vaccination * Born at term (≥37 weeks gestation) * Medically stable at the time of vaccination * Parent or legal guardian able to provide written informed consent Exclusion Criteria * Infants with neurological disorders or developmental delay * Use of analgesic, antipyretic, or sedative medications within 24 hours prior to vaccination * Skin conditions or contraindications at the injection site * Hearing impairment that may affect response to white noise * History of adverse reactions to vaccination * Preterm infants (\<37 weeks gestation)

What they're measuring

FLACC Pain Score During Vaccination

Timeframe: Periprocedural (during vaccination)

Trial details

NCT IDNCT07286721

SponsorIstanbul Arel University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

View on ClinicalTrials.gov More Infant Pain Management trials