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NCT Number: NCT07749235

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pain Behavior Communication Crying Fear Neurologic Manifestations Nonverbal Communication Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Medicana Bursa Hospital

Bursa, Nilüfer, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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).

Primary outcomes

  1. Children's Fear Scale

    Time frame: Periprocedural

    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.

  2. Wong-Baker Faces Pain Rating Scale-WBFPRS

    Time frame: Periprocedural

    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.

  3. Crying Duration

    Time frame: Periprocedural

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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