Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique

NCT ID: NCT06246266

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2024-12-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Helfer Skin Tap Technique group

Mechanical stimulation given with the Helfer Skin Tap technique during intramuscular vaccine administration will distract the baby's attention.

Group Type: EXPERIMENTAL

Helfer Skin Tap Technique group

Intervention Type: PROCEDURE

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.

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).

Group Type: EXPERIMENTAL

ShotBlocker Technique group

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Esra TURAL BUYUK

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Helfer Skin Tap

Identifier Type: -

Identifier Source: org_study_id