The Effect of the Helfer Skin Tap and Buzzy Application on Vaccination Pain, Fear and Crying Duration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ege University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Children's Fear Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 9 Months to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bee Buzzy
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.
Intervention: Bee Buzzy (Device)
Helfer Skin Tap (HST) Technique Group:
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).
Intervention: Helfer Skin TAp (Behavioral)
control group
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.
Outcomes
Primary Outcomes
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.
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.
Crying Duration
Time Frame: Periprocedural
Secondary Outcomes
No secondary outcomes reported
Investigators
Furkan Torun
Phd Candidate
Ege University