White Noise and Buzzy for Reducing Pain During Infant Vaccination

NCT07286721 | Active Not Recruiting

• 1 other identifier: 2025/21
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Infant pain; White noise; Buzzy; Vaccination; Nursing

Outcome Measures

Primary Outcomes (1)

• FLACC Pain Score During Vaccination

  Pain during vaccination will be assessed using the FLACC Pain Assessment Scale (Face, Legs, Activity, Cry, Consolability). Scores range from 0 to 10, with higher scores indicating greater pain. Pain will be independently evaluated for each infant by a blinded observer and a parent.

  Periprocedural (during vaccination)

Secondary Outcomes (1)

• Agreement Between Parent and Observer FLACC Pain Scores

  Immediately after vaccination

Study Arms (3)

White Noise Group

EXPERIMENTAL

Infants in this group will listen to white noise beginning approximately 1-2 minutes before the vaccination and continuing throughout the injection procedure. The white noise device will be placed safely within hearing distance of the infant. Pain will be assessed using the FLACC Pain Assessment Scale by a blinded observer and a parent.

Other: Standard Care (in control arm)

Buzzy Device Group

EXPERIMENTAL

Infants in this group will receive vibration and cold stimulation using the Buzzy device. The device will be placed about 3 cm above the injection site 60 seconds before vaccination and will remain active until the procedure is completed. Pain will be assessed using the FLACC Pain Assessment Scale by a blinded observer and a parent.

Other: Standard Care (in control arm)

Control Group

EXPERIMENTAL

Infants in this group will receive routine vaccination following standard clinical practice with no additional non-pharmacological intervention. Pain will be assessed using the FLACC Pain Assessment Scale by a blinded observer and a parent.

Other: Standard Care (in control arm)

Interventions

Standard Care (in control arm) OTHER

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.

Buzzy Device Group; Control Group; White Noise Group

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 2 to 6 months
• Receiving routine hexavalent vaccination
• Born at term (≥37 weeks gestation)
• Medically stable at the time of vaccination

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Arel University: lead

Study Sites (1)

Büyükçekmece Central Family Health Center

Istanbul, Istanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: September 25, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)