Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique

Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique in Reducing Pain in Babies Receiving Intramuscular Vaccination

The purpose of this study is to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Procedure: Helfer Skin Tap Technique group; Procedure: ShotBlocker Technique group

Detailed Description

During immunization, babies feel pain from the injection and give behavioral reactions such as crying and struggling in response to this pain. Pain-reducing methods (Buzzy device, cold application, hot application, music, virtual reality, distracting cards, stress ball, etc.) are used during intramuscular vaccine injection in children. Studies using the Helfer Skin Tap Technique and ShotBlocker Technique, which are easy to apply and proven effective in reducing pain in infancy vaccination applications, are limited.

Therefore, this study aims to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Born between 38 and 42 weeks of gestation,
• Between 2 and 4 months old,
• Applying to the family health center for KPA (Conjugated Pneumococcal Vaccine) application,
• No congenital anomalies, birth asphyxia or any chronic disease

Exclusion Criteria:

• Born prematurely or postmaturely
• Not between 2 and 4 months old
• Those who come to the family health center for the administration of other vaccines other than the KPA (Conjugated Pneumococcal Vaccine) application administered via IM route.
• Those with congenital anomalies, birth asphyxia or any chronic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Helfer Skin Tap Technique group; Mechanical stimulation given with the Helfer Skin Tap technique during intramuscular vaccine administration will distract the baby's attention.	Procedure: Helfer Skin Tap Technique group; During intramuscular vaccine administration, the muscle will be tapped with the palmar surface of the fingers of the other hand that is not used, with light rhythmic movements, counting for 1-15 seconds. Then, when the muscle is entered with the injection, it will continue to be hit with light rhythmic movements for 1-3 seconds. Thus, the muscle will relax and the fibers around the muscle will be stimulated. Mechanical stimulation given with the Helfer Skin Tap technique during intramuscular vaccine administration will distract the baby's attention.
Experimental: ShotBlocker Technique group; During intramuscular vaccine administration to babies, the injection ShotBlocker Technique will be applied using the ShotBlocker tool (a tool with a "U" appearance, with blunt but not pointed protrusions).	Procedure: ShotBlocker Technique group; The protruding but not sharp surface on the ShotBlocker tool will be placed on the baby's skin before intramuscular vaccine administration. Injection will be applied to the middle part of this vehicle, which has a 'U' appearance. This tool, which does not cause any harm to the skin surface, will provide stimulation to the muscle fibers according to the Gate Control Theory related to pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Infant Pain Scale = NIPS	The Newborn-Infant Pain Scale, developed by Lawrence et al. (1993) to evaluate the physiological and behavioral responses of newborns to pain, was adapted into Turkish by Akdovan (1999). Scale; It consists of five behavioral and one physiological parts, including facial expression, crying, breathing pattern, arm and leg movements, and sleep-wake state. The crying part of the scale is given 0-1 and 2 points, and the other parts are given 0-1 point. The total score can range from 0 to 7, and a score higher than 3 indicates greater pain intensity.	Immediately after vaccination, the baby's pain will be evaluated with the Newborn Infant Pain Scale (NIPS).

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Estimated): February 5, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pain; vaccine; infant; ShotBlocker; Helfer Skin Tap Technique; ıntramuscular
• Other Study ID Numbers: Helfer Skin Tap

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No