NCT06454812

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

The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Healthy Infants During Intramuscular Vaccination: a Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Istanbul Medeniyet University · Academic / Other
• Sex: All
• Age: 6 Months – 7 Months
• Healthy volunteers: Accepted

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.

Detailed description

Vaccination is one of the painful procedures routinely performed in infants. The pain experienced by the infant negatively affects the prognosis of the disease, the infant's behavior, the harmony with the environment, the development of the brain and senses, as well as the family infant interaction. Nonpharmacologic methods have been found to be effective in alleviating pain during interventions that cause pain caused by medical procedures that infants frequently encounter. Mechanical vibration and Helfer skin tap technique are effective methods that can be used in nonpharmacologic procedural pain management. Studies have commonly used parent-related methods (kangaroo care, mother/ father cuddling, breastfeeding, etc.) for neonatal pain management during vaccine administrations. In units where access to the parent is not always possible, nonpharmacologic pain methods that can be used independently of the parent can be used in the management of needle related acute pain. In addition, no study was found in the literature comparing the effect of mechanical vibration and Helfer skin tap technique on hepatitis B and DTaP-IPV-Hib vaccinations-related pain. This study will be investigated the effects of mechanical vibration and Helfer skin tap technique methods on procedural pain, crying time and duration of the procedure during intramuscular vaccinations in healthy term infants.

Conditions

• Procedural Pain
• Nursing Caries
• Pain, Acute

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-07-15
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2024-06-12
• Last updated: 2025-01-13

Locations

1 site across 1 country: Turkey (Türkiye)