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

NCT07749235 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 26-2T/75
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Crying; Pain; Fear

Keywords

infant; vaccination; pain; fear; crying

Outcome Measures

Primary Outcomes (3)

• Children's Fear Scale

  The Fear Facial Expression Scale was adapted for adults as "The Faces Anxiety Scale" by McKinley et al. (2003). The same scale was subsequently adapted for pediatric medical contexts as the "Children's Fear Scale" by McMurtry et al. (2011). This scale features five distinct facial expressions. It is scored on a scale of 0 to 4 and is recognized as a reliable and valid measurement tool for assessing fear. A study on its Turkish validity and reliability, conducted by Binay Yaz and Bal Yılmaz (2019), demonstrated that the scale is a reliable instrument for measuring fear of medical treatment and surgical procedures across all pediatric age groups.

  Periprocedural

• Wong-Baker Faces Pain Rating Scale-WBFPRS

  It is the most frequently used scale for pain assessment in pediatric patients because it has been reported to effectively differentiate pain levels across all age groups of children. Six (6) facial expressions, rated from 0 to 10 based on the presence and severity of pain, are utilized. The facial expressions are categorized as follows: "0" (smiling/no pain), 1-2 ("hurts a little"), 3-4 ("hurts a little more"), 5-6 ("hurts even more"), 7-8 ("hurts a lot"), and 9-10 ("hurts the most"). This scale does not require verbal expression or numerical values and serves as a reliable and valid measurement tool for assessing acute pain.

  Periprocedural

• Crying Duration

  Periprocedural

Study Arms (3)

Bee Buzzy

EXPERIMENTAL

Buzzy the Bee will be used on the patient during the 9-month vaccination procedure. Thanks to its cold wings and vibration, Buzzy reduces pain and helps distract the patient during the injection, thereby alleviating feelings of pain and fear. Buzzy will be placed 5 cm above the injection site; after a 15-second wait, the actual vaccination will be administered.

Device: Bee Buzzy

Helfer Skin Tap (HST) Technique Group:

EXPERIMENTAL

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).

Behavioral: Helfer Skin TAp

control group

NO INTERVENTION

No intervention other than the administration of the vaccine by the nurse will be performed on the 9-month-old infant in this group. The 9-month-old infant will receive routine vaccination.

Interventions

Bee Buzzy DEVICE

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.

Bee Buzzy

Helfer Skin TAp BEHAVIORAL

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).

Helfer Skin Tap (HST) Technique Group:

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth between the 38th and 42nd weeks of gestation
• Having completed the 9th month postpartum
• Being followed under the standard immunization program in accordance with the national vaccination schedule.
• Babies of mothers who can speak and understand Turkish

You may not qualify if:

• Having an acute or chronic illness
• Having a history of allergies
• Presence of nerve damage or limb deformity at the injection site
• Having received analgesic treatment within the 24 hours prior to immunization

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Private Medicana Bursa Hospital

Bursa, Nilüfer, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Crying

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nonverbal Communication; Communication; Behavior

Study Officials

• Hatice BAL, Prof. Dr.

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Candidate

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 6, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): May 29, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

TU (1)