Cold Spray and Helfer Skin Tap for Pain During Infant Vaccination
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-12
SponsorHitit University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cold spray
- Helfer Skin Tap Technique
Treatment groups
120 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov