An interventional study of Cold spray and Helfer Skin Tap Technique in Procedural Pain, Vaccination Pain and Injection Pain, sponsored by Hitit University. Not yet recruiting. Open to participants aged 12 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Hitit University · Not applicable, Interventional, and Treatment
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.
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 120 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Hitit University is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Infants in this group will receive cold spray before intramuscular pneumococcal conjugate vaccination. Cold spray will be applied to the injection site from a distance of 15 cm for 5 seconds before the vaccine injection.
Other: Cold spray
Infants in this group will receive the Helfer Skin Tap technique before and during intramuscular pneumococcal conjugate vaccination. The technique will be applied by tapping near the injection site in coordination with needle insertion.
Other: Helfer Skin Tap Technique
Infants in this group will receive routine intramuscular pneumococcal conjugate vaccination without any additional pain-reducing intervention.
Cold spray will be applied to the injection site from a distance of 15 cm for 5 seconds before intramuscular pneumococcal conjugate vaccination.
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.
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 vaccination
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 vaccination
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 vaccination
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 vaccination
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 vaccination
Body Temperature Before and After Vaccination
Body temperature will be measured immediately before and immediately after vaccination and recorded in degrees Celsius (°C).
Time frame: Immediately before and immediately after vaccination
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared because the study population consists of 12-month-old infants, and the collected data include sensitive health-related information. Data will be used only by the research team for the purposes of this study. Results will be reported in aggregate form without identifying individual participants.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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