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Cold Spray and Helfer Skin Tap for Pain During Infant Vaccination
Sponsor: Hitit University
Summary
This randomized controlled experimental study aims to evaluate the effects of cold spray and the Helfer Skin Tap technique on pain levels during intramuscular pneumococcal conjugate vaccine administration in 12-month-old infants. Vaccination is one of the most common painful procedures during infancy. Pain experienced during injections may cause distress in infants and anxiety in families. Therefore, simple, safe, non-pharmacological methods that can reduce injection-related pain are important in pediatric nursing and primary health care. The study will be conducted at Çorum Söğütlüevler Family Health Center between March 2026 and March 2027. The study population will consist of 12-month-old infants who attend the family health center for intramuscular pneumococcal conjugate vaccination. A total of 120 infants are planned to be included in the study. Participants will be assigned to one of three groups by stratified block randomization: cold spray group, Helfer Skin Tap group, or control group. Each group will include 40 infants. Infants in the control group will receive routine vaccination without any additional intervention. In the cold spray group, cold spray will be applied to the injection site before vaccination. In the Helfer Skin Tap group, the technique will be applied before and during the injection by gently tapping near the injection site in coordination with needle insertion. Data will be collected using a Child Information Form, an Application Record Form, and the Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC). Pain responses will be evaluated before, during, and after vaccination. Crying duration and physiological parameters such as pulse, oxygen saturation, and body temperature will also be recorded. The findings of this study are expected to contribute to evidence-based pediatric nursing practices by identifying whether cold spray or the Helfer Skin Tap technique is effective in reducing pain during infant vaccination.
Official title: The Effect of Cold Spray and Helfer Skin Tap Technique Used in Intramuscular Vaccinatıon on Pain Levels
Key Details
Gender
All
Age Range
12 Months - 12 Months
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-09-15
Completion Date
2027-09-01
Last Updated
2026-08-21
Healthy Volunteers
Yes
Interventions
Cold spray
Cold spray will be applied to the injection site from a distance of 15 cm for 5 seconds before intramuscular pneumococcal conjugate vaccination.
Helfer Skin Tap Technique
The Helfer Skin Tap technique will be applied before and during intramuscular pneumococcal conjugate vaccination by tapping near the injection site in coordination with needle insertion.