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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cold spray
Other interventionCold 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
Other interventionThe 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.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Cold Spray GroupExperimental treatment 1 intervention
Group B: Helfer Skin Tap GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain Level During Vaccination Assessed by FLACC Scale
Pain level will be assessed using the Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC). The FLACC scale evaluates five behavioral categories: face, legs, activity, cry, and consolability. Each category is scored from 0 to 2, and the total score ranges from 0 to 10. Higher scores indicate higher pain levels.
Time frame
During intramuscular pneumococcal conjugate vaccinationSecondary outcomes
1
Pain Level Before and After Vaccination Assessed by FLACC Scale
Pain level will be assessed before and after vaccination using the FLACC scale. The total score ranges from 0 to 10, with higher scores indicating higher pain levels.
Time frame
Before vaccination and immediately after vaccination2
Crying Duration
Crying duration will be recorded in seconds using a stopwatch during and after the vaccination procedure. Longer crying duration indicates greater behavioral distress.
Time frame
During vaccination and immediately after vaccination3
Pulse Rate Before and After Vaccination
Pulse rate will be measured immediately before and immediately after vaccination and recorded in beats per minute (bpm).
Time frame
Immediately before and immediately after vaccination4
Peripheral Oxygen Saturation Before and After Vaccination
Peripheral oxygen saturation (SpO₂) will be measured immediately before and immediately after vaccination and recorded as a percentage (%).
Time frame
Immediately before and immediately after vaccinationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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