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Not yet recruitingNCT06246266Updated Feb 7, 2024

Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique

An interventional study of Helfer Skin Tap Technique group and ShotBlocker Technique group in Pain, sponsored by Ondokuz Mayıs University. Not yet recruiting. Open to participants aged 2 Months to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
2 Months to 4 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • infant
  • ıntramuscular
  • vaccine
  • Helfer Skin Tap Technique
  • ShotBlocker
  • pain
03

In context

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 4 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureHelfer 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.

  • ProcedureShotBlocker 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.

06

What researchers measure

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.

    Time frame: Immediately after vaccination, the baby's pain will be evaluated with the Newborn Infant Pain Scale (NIPS).

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06246266
Lead sponsor
Ondokuz Mayıs University
Responsible party
Esra TURAL BUYUK (Associate Professor, Ondokuz Mayıs University) — Principal investigator
First posted
Feb 7, 2024
Start date
Feb 5, 2024 (estimated)
Primary completion
Sep 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Feb 7, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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