Cold Spray and Helfer Skin Tap for Pain During Infant Vaccination

Pain during vaccination is a common source of distress for infants and concern for families. Since infants cannot verbally express pain, behavioral pain assessment tools are needed to evaluate their pain responses during painful procedures. Non-pharmacological methods that are simple, low-cost, and easy to apply may help reduce injection-related pain in primary health care settings.

This study is designed to compare two non-pharmacological pain management methods, cold spray and the Helfer Skin Tap technique, during intramuscular pneumococcal conjugate vaccine administration in 12-month-old infants. The study will be conducted in a family health center setting, where routine infant vaccinations are performed.

Eligible infants will be randomly assigned to one of three groups: a cold spray group, a Helfer Skin Tap group, or a control group. In the control group, infants will receive the routine intramuscular vaccine injection without any additional pain-reducing intervention. In the cold spray group, cold spray will be applied to the injection site before the vaccine injection. In the Helfer Skin Tap group, the researcher will apply rhythmic tapping near the injection area before and during needle insertion according to the technique.

Pain will be assessed using the Face, Legs, Activity, Cry, Consolability Pain Scale, known as the FLACC scale. Pain responses will be evaluated before, during, and after the vaccination procedure. Crying duration will also be recorded as an additional behavioral indicator of pain. Physiological parameters, including pulse, oxygen saturation, and body temperature, will be measured before and after the injection.

The study aims to determine whether cold spray or the Helfer Skin Tap technique reduces pain compared with routine vaccination practice and whether one method is more effective than the other. The results may provide evidence for pediatric nurses and primary health care professionals on the use of practical non-pharmacological pain management methods during infant vaccination.

Inclusion criteria

• Parent or legal guardian has at least primary school education.
• Parent or legal guardian agrees for the infant to participate in the study.
• The infant is scheduled to receive the pneumococcal conjugate vaccine by - intramuscular injection.
• The infant was born between 38 and 42 weeks of gestation.
• The infant is 12 months old.
• The infant's body weight corresponds to the 50th percentile.

Exclusion criteria

• Parent or legal guardian is illiterate.
• The infant was born preterm or postterm.
• The infant attends the family health center for a vaccine other than the pneumococcal conjugate vaccine.
• The infant has a congenital anomaly, birth asphyxia, or any chronic disease.
• The infant received an analgesic medication within at least 4 hours before vaccination.