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The Effect of the Helfer Skin Tap and Buzzy Application on Vaccination Pain, Fear and Crying Duration

NCT07749235 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-06

No results posted yet for this study

Summary

To minimize the pain and discomfort during vaccination, one of three different methods will be used. One method involves using 'Buzzy,' a small, bee-shaped device that provides vibration and a cooling sensation; another involves massaging the injection site by tapping it rhythmically with our fingertips; and the third follows the standard vaccination procedure. Participants will be randomly assigned to the group.

Conditions

Interventions

DEVICE

Bee Buzzy

Buzzy the Bee will be attached to the leg where the 9-month-old infant-included in this group by the researcher-is to receive the vaccine. Thanks to its cold wings and vibration, Buzzy the Bee reduces pain; it helps distract attention during the vaccination process, thereby alleviating feelings of pain and fear. Buzzy the Bee will be secured 5 cm above the injection site, and the nurse will administer the vaccine after a 15-second wait.

BEHAVIORAL

Helfer Skin TAp

HST technique maneuvers will be applied to the 9-month-old infants in this group during vaccination. HST consists of a four-stage tapping sequence. The administering nurse will perform approximately 10 taps over a 5-second period using the palmar surface of the dominant hand's fingers to relax the leg muscles at the injection site (Stage 1). Following skin disinfection, the nurse will position the thumb and index finger of the non-dominant hand in a V-shape and perform 3 taps on the injection site using the palmar surface of those fingers (Stage 2). Simultaneously with the third tap, the nurse will insert the needle into the muscle at a 90-degree angle while continuing to tap the skin lightly with the palmar surface of the non-dominant hand's fingers (Stage 3). Once the medication has been fully administered, the nurse will perform 3 taps on the skin with the palmar surface of the non-dominant hand's fingers and withdraw the needle simultaneously with the final tap (Stage 4).

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Hatice BAL, Prof. Dr. · Ege University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-27
Primary Completion
2026-12-29
Completion
2027-05-29
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

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 NCT07749235 on ClinicalTrials.gov