Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique

NCT06246266 | Unknown

• 1 other identifier: Helfer Skin Tap
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

infant; ıntramuscular; vaccine; Helfer Skin Tap Technique; ShotBlocker; pain

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Helfer Skin Tap Technique group

EXPERIMENTAL

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

ShotBlocker Technique group

EXPERIMENTAL

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

Interventions

Helfer Skin Tap Technique group 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.

Helfer Skin Tap Technique group

ShotBlocker Technique group 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.

ShotBlocker Technique group

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: February 5, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share