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The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Infants During Vaccination

NCT06454812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-01-13

No results posted yet for this study

Summary

This study will be conducted to determine the effect of mechanical vibration and Helfer Skin Tap technique applied during intramuscular vaccinations on procedural pain level, crying time and procedure time in healthy infants.

Conditions

  • Procedural Pain
  • Nursing Caries
  • Pain, Acute

Interventions

DEVICE

Mechanical vibration

The vibration device will be placed on the procedure site (on the vastus lateralis muscle) on the left extremity and fixed through a long gauze. The vibration device will be operated for 30 seconds with reference to previous studies, then the nurse will administer routine intramuscular Hepatitis B vaccine. A gap of approximately 1-2 cm will be left between the device and the injection site. After the vaccination procedure is completed, the vibration will be terminated. The same procedure was repeated for DTaP-IPV-Hib vaccine administered to the the right extremity. The baby will be swaddled and placed in the mother's lap.

BEHAVIORAL

Helfer skin tap technique (HSTT)

In this group, HSTT consisting of 4-stage strokes will be applied to the vaccination site. The nurse will make approximately 10 strokes for 5 seconds with the palmar side of the fingers of the dominant hand to the injection site to relax the muscles (Stage 1). The nurse will give a V-shaped position to the thumb and index finger of the non-dominant hand and give 3 strokes to the injection site with the palmar side of the fingers (Stage 2). The skin entry site of the needle will remain inside the V-shape. Simultaneously with the 3rd stroke, the nurse will insert the needle into the muscle at a 90 degree angle. The nurse will inject the vaccine into the muscle while continuing to tap the skin with the palmar side of the fingers of the non-dominant hand (Stage 3). The nurse will make 3 strokes on the skin with the palmar side of the fingers of the non-dominant hand at the injection site, simultaneously with the 3rd stroke, the needle will be removed from the baby's skin (Stage 4).

Sponsors & Collaborators

  • Istanbul Medeniyet University

    lead OTHER

Principal Investigators

  • Aynur Aytekin Özdemir, PhD · Istanbul Medeniyet University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2024-12-15
Completion
2024-12-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06454812 on ClinicalTrials.gov