An interventional study of Bee Buzzy and Helfer Skin TAp in Pain, Fear and Crying, sponsored by Ege University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 9 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Ege University · Not applicable, Interventional, and Other
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.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 90 is above the median of 70 across 1,904 interventional studies indexed under Pain.
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Exclusion Criteria:
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
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
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.
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.
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).
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.
Time frame: 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.
Time frame: Periprocedural
Crying Duration
Time frame: Periprocedural
Plan to share: Yes
Supporting information: Icf
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Ege University