Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique

Not Applicable

Not yet recruiting

• Conditions: Pain
• Interventions: Procedure: ShotBlocker Technique group; Procedure: Helfer Skin Tap Technique group

• Registration Number: NCT06246266
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

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.

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study Start: 2024-02-05
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ShotBlocker Technique group	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).
Helfer Skin Tap Technique group	Helfer Skin Tap Technique group	Mechanical stimulation given with the Helfer Skin Tap technique during intramuscular vaccine administration will distract the baby's attention.

Primary Outcome Measures

Name	Time	Method
Neonatal Infant Pain Scale = NIPS	Immediately after vaccination, the baby's pain will be evaluated with the Newborn 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.